Title: Irradiation Phytosanitary Treatment of Imported Fruits and Vegetables.

OMB Control Number: 0579-0155.

Type of Request: Revision to and extension of approval of an information collection.

Abstract: Under the Plant Protection Act (7 U.S.C. 7701 et seq. ), the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture is authorized, among other things, to regulate the importation of plants, plant products (including fruits and vegetables), and other articles to prevent the introduction of plant pests, diseases, and noxious weeds into the United States.

Regulations governing the importation of fruits and vegetables are set out in 7 CFR part 319. In accordance with the regulations, some fruits and vegetables from certain regions of the world must be treated for insect pests in order to be eligible for entry into the United States.

The regulations in 7 CFR part 305, among other things, provide for the use of irradiation as a phytosanitary treatment for some fruits and vegetables imported into the United States. Irradiation provides protection against all insect pests, including fruit flies, the mango seed weevil, and others. Irradiation treatment may be used as an alternative to other approved treatments for pests in fruits and vegetables, such as fumigation, cold treatment, heat treatment, and other techniques.

The regulations concerning irradiation involve the collection of information, such as a compliance agreement, operational work plans (cooperative agreements), dosimetry agreement at the irradiation facility, request for dosimetry device approval, 30-day notification, labeling and packaging, recordkeeping, request for certification and inspection of facility, irradiation treatment workplan, facility preclearance workplan, trust fund agreement, phytosanitary certificate, and denial and withdrawal of certification.

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

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

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

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

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

(4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses.

Estimate of burden: The public burden for this collection of information is estimated to average 0.001 hours per response.

Respondents: National plant protection organizations of exporting countries, irradiation facility operators, and U.S. importers of fruits and vegetables.

Estimated annual number of respondents: 86.

Estimated annual number of responses per respondent: 71,334.

Estimated annual number of responses: 6,134,715.

Estimated total annual burden on respondents: 6,902 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

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

Title: Modernization of Swine Slaughter Inspection.

OMB Number: 0583-0171.

Type of Request: Request to renew an approved information collection.

Abstract: FSIS has been delegated the authority to exercise the functions of the Secretary (7 CFR 2.18, 2.53), as specified in the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601, et seq. ). This statute mandates that FSIS protect the public by verifying that meat products are safe, wholesome, unadulterated, and properly labeled and packaged.

FSIS is requesting a renewal of the approved information collection regarding swine slaughter inspection. The approval for this information collection will expire on January 31, 2023. FSIS is making no changes to the information collection.

FSIS requires that all swine slaughter establishments operating under the New Swine Slaughter Inspection System (NSIS) monitor their systems through microbial testing and recordkeeping. Swine slaughter establishments operating under NSIS must also maintain records to document the total number of animals and carcasses sorted and removed per day and the reasons for their removal. Swine Slaughter establishments may record their disposition data on FSIS Form 6200-3, Establishment Sorting Record, or provide the same information as requested on the form electronically if it is submitted in a format approved by FSIS.

FSIS also requires that each establishment operating under the NSIS submit on an annual basis an attestation to the management member of the local FSIS circuit safety committee stating that it maintains a program to monitor and document any work-related conditions of establishment workers.

FSIS has made the following estimates based upon an information collection assessment:

Estimate of burden: The public reporting burden for this collection of information is estimated to average .048 hours per response.

Estimated total number of respondents: 84.

Estimated annual number of responses: 91,078.

Estimated total annual burden on respondents: 4,348 hours.

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record. Copies of this information collection assessment can be obtained from Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW, Mailstop 3758, South Building, Washington, DC 20250-3700; (202) 720-5627.

Comments are invited on: (a) whether the proposed collection of information is necessary for the proper performance of FSIS' functions, including whether the information will have practical utility; (b) the accuracy of FSIS' estimate of the burden of the proposed collection of information, including the validity of the method and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology. Comments may be sent to both FSIS, at the addresses provided above, and the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Washington, DC 20253.

Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS web page located at: https://www.fsis.usda.gov/federal-register.

FSIS will also announce and provide a link to this Federal Register publication through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Constituent Update is available on the FSIS web page. Through the web page, FSIS can provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: https://www.fsis.usda.gov/subscribe. Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves and have the option to password protect their accounts.

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

Persons with disabilities who require alternative means of communication for program information ( e.g., Braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or contact USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English.

To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint and at any USDA office or write a letter addressed to USDA and provide in the letter all of the information requested in the form. To request a copy of the complaint form, call (866) 632-9992.

Submit your completed form or letter to USDA by: (1) mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410; (2) fax: (202) 690-7442; or (3) email: program.intake@usda.gov. USDA is an equal opportunity provider, employer, and lender.

Purpose and Need

The Rehabilitation Project would be implemented as agricultural water management, as authorized under sections 3 and 4 of Public Law 83-566. The primary purpose of the Rehabilitation Project is to provide a clean dependable water supply for the Upper Hood River valley in Hood River County, Oregon, as authorized in the 1962 Middle Fork Hood River Watershed Work Plan. An assessment of Clear Branch Dam was performed by NRCS and the Project Sponsor in 2015 to evaluate the condition of the dam. Results of the assessment indicated that modifications to Clear Branch Dam are needed to extend its service life. To meet the purpose of providing a clean dependable water supply, there is a need to rehabilitate Clear Branch Dam to meet current dam safety and environmental compliance standards for NRCS, the Forest Service, FERC, and other regulatory agencies. Action to rehabilitate the dam is necessary because the dam reached the end of its original service life and requires structural modifications to extend its service life another 50 to 100 years. The need for watershed planning is established and implementation of management actions are authorized under Public Law 83-566, the Watershed Protection and Flood Prevention Act of 1954 (16 U.S.C. 1001-1009), as amended, and Public Law 78-534, the Flood Control Act of 1944 (33 U.S.C. 702b-1). Further context for the need for watershed planning is provided below.

A Watershed Work Plan for Middle Fork Hood River Watershed in Hood River County, Oregon was authorized by the Soil Conservation Service, the predecessor to NRCS, and its partners in 1962, under the authority of the Watershed Protection and Flood Prevention Act. The primary objective of the Rehabilitation Project is to provide a clean dependable water supply and improved water distribution system for the irrigation of 8,000 acres; this objective was accomplished with the construction of a reservoir on Clear Branch of the Middle Fork Hood River in 1968, named Clear Branch Dam. The dam is owned and operated by the Middle Fork Irrigation District. Today, the reservoir behind Clear Branch Dam provides water to 404 users to irrigate 6,362 acres in the Upper Hood River valley.

In 2016, NRCS, the Forest Service, and the Project Sponsor initiated scoping for an Environmental Assessment for the rehabilitation of Clear Branch Dam. A public scoping meeting was conducted on August 15, 2016, in Parkdale, Oregon.

Since scoping for the Environmental Assessment (EA) was completed in 2016, NRCS, the Forest Service, and the Project Sponsor have completed additional investigations and studies to evaluate the condition of the dam. As a result of the new information obtained during the EA process, the rehabilitation needed is more extensive than anticipated during scoping in 2016. Estimated federal funds required for the construction of the proposed action may exceed $25 million and the proposed action will therefore require congressional approval per the 2018 Agriculture Appropriations Act amended funding threshold. In accordance with 7 CFR 650.7(a)(2), an EIS is required for projects requiring congressional approval.

The 1962 Middle Fork Hood River Watershed Work Plan would be updated to include an EIS that would analyze alternative ways to meet the Rehabilitation Project's purpose and need. At least three Action Alternatives will be evaluated to meet the purpose and need of the Rehabilitation Project. A No Action Alternative will also be considered.

Alternative 1 (Proposed Action)—Structural Rehabilitation. This alternative would structurally rehabilitate the dam to meet current dam safety and environmental compliance standards of NRCS, the Forest Service, FERC, and other regulatory agencies. Structural rehabilitation includes measures to address flood conveyance, seepage, seismic hazards, fish passage, and water quality improvements.

Alternative 2—Decommission. Decommissioning the dam would consist of breaching the dam to allow for flood conveyance, restoring Clear Branch and Pinnacle Creek within the reservoir footprint, and the constructing of run-of river irrigation diversions to continue irrigation water supply.

Alternative 3—Nonstructural Rehabilitation. This alternative would relocate or floodproof at-risk dwellings in the downstream breach inundation area. The downstream breach inundation area extends from the base of Clear Branch Dam to the mouth of the Hood River confluence with the Columbia River. This zone includes 4 homes, 2 apartments or hotels, 23 commercial buildings, 4 bridges, Highway 30, Interstate 84, the Union Pacific railroad, and the Mount Hood Railroad.

Alternative 4—No Action. Taking no action would consist of activities carried out if no federal action or funding were provided. In the absence of federal funding, the Project Sponsor would implement the structural dam rehabilitation alternative (Alternative 3) using alternate funding and likely extended timetable for completion.

Initial agency scoping of this federally assisted action indicates that the Rehabilitation Project may cause significant impacts on the environment. Ron Alvarado, NRCS Oregon State Conservationist, has determined that the preparation of an EIS is needed for this Rehabilitation Project. This EIS will be prepared as required by section 102(2)(C) of the National Environmental Policy Act of 1969 (NEPA); the Council on Environmental Quality Regulations (40 CFR parts 1500-1508); and NRCS regulations that implement NEPA in 7 CFR part 650.

Species listed under the Endangered Species Act (ESA)may be affected by the proposed action. The reservoir behind the dam is designated as critical habitat for bull trout ( Salvelinus confluentus ). The Middle Fork Hood River sub-basin supports spring Chinook Salmon ( Oncorhynchus tshawytscha ), winter steelhead trout ( Oncorhynchus mykiss ), bull trout, and cutthroat trout ( Oncorhynchus clarkii ). Winter steelhead and bull trout are listed as threatened under ESA and critical habitat for both of these species is designated in the Middle Fork Hood River sub-basin. Critical habitat for the Lower Columbia River Chinook Salmon Evolutionarily Significant Unit is designated in the Middle Fork Hood River sub-basin. Critical habitat for the Northern Spotted Owl ( Strix occidentalis caurina ) is mapped near the confluences of Clear Branch, Pinnacle Creek, Coe Branch, and Eliot Branch. U.S. Forest Service Road 2840 accesses the dam and the Laurance Lake recreation facilities. Some alternatives may involve excavation, grading, surveying, limited closure, blocking, or detouring traffic in the right of way during construction.

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

• CWA Section 404 Permit. CWA Implementation of the proposed federal action may require a Clean Water Act (CWA) section 404 permit from the U.S. Army Corps of Engineers;

• CWA Section 401 Permit. The Rehabilitation Project may also require water quality certification under section 401 of CWA;

• U.S. Fish and Wildlife Service ESA section 7 Consultation;

• National Marine Fisheries Service ESA section 7 Consultation;

• Forest Service Special Use Permit; and

• County Permit. Implementation of the proposed federal action may require permit from Hood River County.

A Draft EIS (DEIS) will be prepared and circulated for review and comment by agencies, Tribes, section 106 consulting parties, and the public for at least 45 days per 40 CFR 1503.1, 1502.20, 1506.11, and 1502.17, and 7 CFR 650.13. The DEIS is anticipated to be published in the Federal Register in 2023, approximately 16 months after publication of this NOI. A Final EIS is anticipated to be published within 6 months of completion of the public comment period for the DEIS.

NRCS, in cooperation with the Forest Service, will decide whether to implement one of the alternatives as evaluated in the EIS. Since the Rehabilitation Project is located on National Forest System (NFS) lands, the Forest Service's decision will include whether to authorize construction on NFS lands and whether to issue a new or amended special use permit for continuing to operate Clear Branch Dam on NFS lands. The Forest Service may also issue a decision associated with conformance with the Mt. Hood Land and Resource Management Plan, as amended by the Northwest Forest Plan. An NRCS Record of Decision (ROD) will be completed after the required 30-day waiting period and a Forest Service ROD will be completed after the pre-decisional administrative review process (36 CFR part 218 or 36 CFR part 219) has concluded. The responsible federal official and decision maker for the NRCS is Ron Alvarado, Oregon State Conservationist. The responsible federal official and decision maker for the Forest Service is Meta Loftsgaarden, Mt Hood National Forest Supervisor.

Public scoping meetings will be held to present the Rehabilitation Project and develop the scope of the draft EIS. A preliminary public scoping meeting for an EA was conducted on August 15, 2016, in Parkdale, Oregon. The date, time, and location for a public scoping meeting for the Environmental Impact Statement is:

• Date: Tuesday, October 4, 2022;

• Time: 5 p.m. to 7 p.m. Pacific time;

• Location: Zoom (virtual) and Parkdale Rural Fire Protection District Office at 4895 Baseline Dr., Mt Hood, Parkdale. OR 97041;

• Register at: clearbranchdam.com.

Comments received, including the names and addresses of those who comment, will be part of the public record. Scoping meeting presentation materials are available on the project website: clearbranchdam.com.

NRCS invites agencies, Tribes, section 106 consulting parties, and individuals who have special expertise, legal jurisdiction, or interest in the Rehabilitation Project to provide comments concerning the scope of the analysis and identification of potential alternatives, information, and analyses relevant to the Proposed Action.

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

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

Correction

In the Federal Register of June 3, 2022, in FR Doc 2022-11939, on pages 33718 and 33719, in the first column of each table, correct the header from “Producer/Exporter” to “Exporter.” In addition, on page 33719, in the first column of the first table, correct the list of entities by combining Sailun Jinyu Group Co., Ltd.; Sailun Jinyu Group (Hong Kong) Co., Limited; Shandong Jinyu Industrial Co., Ltd.; Sailun Tire International Corp.; Seatex International Inc.; Dynamic Tire Corp.; and Husky Tire Corp. together, rather than on separate lines.

On June 3, 2022, Commerce published in the Federal Register the amended final results of the 2015-2016 administrative review of the order on passenger tires from the People's Republic of China. 1 We incorrectly labeled the headers in two tables setting forth the weighted-average dumping margins determined in that review as “Producer/Exporter,” instead of “Exporter.” In addition, we incorrectly separated certain entities in the first table, instead of listing them together as determined in the underlying investigation. 2 The corrected tables are below:

Background

On July 16, 2019, Commerce published in the Federal Register the antidumping duty order on OCTG from Ukraine. 1 On July 1, 2021, Commerce published in the Federal Register a notice of opportunity to request an administrative review of the Order on OCTG from Ukraine for the POR July 1, 2020, through June 30, 2021. 2 On September 7, 2021, based on timely requests for review, Commerce initiated an administrative review of the Order. 3 The domestic interested parties are: Maverick Tube Corporation; Tenaris Bay City, Inc.; IPSCO Tubulars Inc.; and United States Steel Corporation. This review covers the sole mandatory respondent, Interpipe. 4

On April 13, 2022, we extended the deadline for the preliminary results of this review by 61 days in accordance with section 751(a)(3)(A) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.213(h)(2). 5 On June 27, 2022, Commerce further extended the deadline for the preliminary results by an additional 59 days. 6 For details regarding the events that occurred subsequent to the initiation of the review, see the Preliminary Decision Memorandum. 7 A list of topics discussed in the Preliminary Decision Memorandum is included in the appendix to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

The merchandise under review is certain OCTG from Ukraine, which are hollow steel products of circular cross-section, including oil well casing and tubing, of iron (other than cast iron) or steel (both carbon and alloy), whether seamless or welded, regardless of end finish ( e.g., whether or not plain end, threaded, or threaded and coupled) whether or not conforming to American Petroleum Institute (API) or non-API specifications, whether finished (including limited service OCTG products) or unfinished (including green tubes and limited service OCTG products), whether or not thread protectors are attached. The scope of the Order also covers OCTG coupling stock. For a full description of the scope, see the Preliminary Decision Memorandum.

Commerce is conducting this review in accordance with section 751(a) of the Act. Constructed export price has been calculated in accordance with section 772 of the Act and normal value was calculated in accordance with section 773 of the Act. For a full description of the methodology underlying these preliminary results, see the Preliminary Decision Memorandum.

Commerce preliminarily determines that the following weighted-average dumping margin exists for the period July 1, 2020, through June 30, 2021:

Commerce will disclose calculations performed for these preliminary results to the parties within five days of the date of publication of this notice, in accordance with 19 CFR 351.224(b).

Case briefs, or other written comments, may be submitted to the Assistant Secretary for Enforcement and Compliance through ACCESS no later than seven days after the date on which the final verification report is issued in this proceeding. 8 Rebuttal briefs, limited to issues raised in the case briefs, may be filed no later than seven days after the date for filing case briefs. 9 Parties who submit case or rebuttal briefs in this proceeding are encouraged to submit with each argument: (1) a statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities. Case and rebuttal briefs should be filed using ACCESS  10 and must be served on interested parties. 11 Note that Commerce has temporarily modified certain of its requirements for serving documents containing business proprietary information, until further notice. 12

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, or to participate if one is requested, must submit a written request to the Assistant Secretary for Enforcement and Compliance, within 30 days of the date of publication of this notice. 13 Requests should contain: (1) the party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs. If a request for a hearing is made, Commerce intends to hold the hearing at a date and time to be determined. 14 Parties should confirm the date, time, and location of the hearing two days before the scheduled date.

Commerce intends to issue the final results of this administrative review, which will include the results of our analysis of all issues raised in the case and rebuttal briefs, within 120 days of publication of these preliminary results in the Federal Register , unless extended, pursuant to section 751(a)(3)(A) of the Act.

On December 16, 2021, the domestic interested parties requested, pursuant to 19 CFR 351.307(b)(1)(v), that Commerce conduct verification of the questionnaire responses submitted in this administrative review. 15 As provided in section 782(i)(1) of the Act, Commerce intends to verify the information relied upon in making its final determination for Interpipe.

Upon issuing the final results of this review, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review. 16 If the weighted-average dumping margin for Interpipe ( i.e., the sole individually-examined respondent in this review) is not zero or de minimis ( i.e., greater than or equal to 0.5 percent) in the final results of this review, we will calculate importer-specific ad valorem assessment rates for the merchandise based on the ratio of the total amount of dumping calculated for the examined sales made during the POR to each importer and the total entered value of those same sales, in accordance with 19 CFR 351.212(b)(1). Where an importer-specific ad valorem assessment rate is zero or de minimis in the final results of the review, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties. 17 If Interpipe's weighted-average dumping margin is zero or de minimis in the final results of the review, we will instruct CBP not to assess duties on any of its entries in accordance with the Final Modification for Reviews, i.e., “{w}here the weighted-average margin of dumping for the exporter is determined to be zero or de minimis, no antidumping duties will be assessed.”  18

In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by Interpipe for which the producer did not know its merchandise was destined for the United States, we will instruct CBP to liquidate those entries at the all-others rate ( i.e., 7.47 percent)  19 if there is no rate for the intermediate company (or companies) involved in the transaction. 20

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 administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for Interpipe will be equal to the weighted-average dumping margin established in the final results of this administrative review, except if the rate is less than 0.50 percent and, therefore, de minimis within the meaning of 19 CFR 351.106(c)(1), in which case the cash deposit rate will be zero; (2) for previously reviewed or investigated companies not listed above, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding in which the company participated; (3) if the exporter is not a firm covered in this review, a prior review, or in the less-than-fair-value investigation (LTFV) but the producer is, the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the producer of the merchandise; and (4) the cash deposit rate for all other producers or exporters will continue to be the all-others rate of 7.47 percent, the rate established in the LTFV investigation of this proceeding. 21 These cash deposit requirements, when imposed, shall remain in effect until further notice.

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

We are issuing and publishing these preliminary results in accordance with sections 751(a)(1) and 777(i) of the Act, and 19 CFR 351.213(h)(2).

Background

On April 30, 2019, Commerce published its Final Results in the 2016-2017 AD administrative review of hot-rolled steel from Australia. 1 Commerce applied facts otherwise available, with an adverse inference, pursuant to sections 776(a) and (b) of the Tariff Act of 1930, as amended (the Act) to BlueScope because it provided deficient responses and failed to provide information in the manner and form requested, thereby significantly impeding the administrative review and failed to cooperate to the best of its ability with Commerce's request for information. BlueScope appealed Commerce's Final Results. On November 30, 2021, the CIT remanded the Final Results to Commerce to reexamine the record in this case, as well as the use of facts available with respect to BlueScope. 2

In its remand redetermination, issued in April 2022, Commerce reevaluated the information on the record and issued a supplemental questionnaire to BlueScope identifying the deficiencies in its previous responses. Based on BlueScope's supplemental response, we recalculated the period of review weighted-average dumping margin for BlueScope consistent with record evidence. 3 The CIT sustained Commerce's Final Redetermination. 4

In its decision in Timken, 5 as clarified by Diamond Sawblades, 6 the U.S. Court of Appeals for the Federal Circuit held that, pursuant to sections 516A(c) and (e) of the Act, Commerce must publish a notice of a court decision that is not “in harmony” with a Commerce determination and must suspend liquidation of entries pending a “conclusive” court decision. The CIT's August 30, 2022, judgment constitutes a final decision of the CIT that is not in harmony with Commerce's Final Results. Thus, this notice is published in fulfillment of the publication requirements of Timken.

Because there is now a final court judgment, Commerce is amending its Final Results with respect to BlueScope as follows:

Because BlueScope has a superseding cash deposit rate, i.e., there have been final results published in a subsequent administrative review, we will not issue revised cash deposit instructions to U.S. Customs and Border Protection (CBP). This notice will not affect the current cash deposit rate.

At this time, Commerce remains enjoined by a CIT order from liquidating entries that: were (a) produced and/or exported by BlueScope Steel Ltd. and BlueScope Steel (AIS) Pty Ltd.; (b) subject to the Final Results; and (c) entered, or withdrawn from warehouse for consumption, on or after March 22, 2016, up to and including September 30, 2017. These entries will remain enjoined pursuant to the terms of the injunction during the pendency of any appeals process.

In the event the CIT's ruling is not appealed, or, if appealed, upheld by a final and conclusive court decision, Commerce intends to instruct CBP to assess antidumping duties on unliquidated entries of subject merchandise produced and/or exported by BSL and BlueScope Steel (AIS) Pty Ltd. in accordance with 19 CFR 351.212(b). We will instruct CBP to assess antidumping duties on all appropriate entries covered by this review when the importer-specific ad valorem assessment rate is not zero or de minimis. Where an import-specific ad valorem assessment rate is zero or de minimis, 7 we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties.

This notice is issued and published in accordance with sections 516A(c) and (e) and 777(i)(1) of the Act.

The development of this Strategic Plan (Plan) was directed by section 12404(c) and guided by section 12405 of the Federal Ocean Acidification Research And Monitoring Act of 2009, 33 U.S.C. 3701-3708, and (FOARAM Act). The Plan is intended to guide “Federal research and monitoring on ocean acidification that will provide for an assessment of the impacts of ocean acidification on marine organisms and marine ecosystems and the development of adaption and mitigation strategies to conserve marine organisms and marine ecosystems.”

This Plan builds on the first Strategic Plan for Federal Research and Monitoring of Ocean Acidification, released in 2014. The present document serves as the required 5-year update and revision to this 2014 document. The 2014 Strategic Plan and this new Strategic Plan focus on the seven priority themes identified in the FOARAM Act: (1) monitoring; (2) research; (3) modeling; (4) technology development; (5) socioeconomic impacts; (6) education, outreach, and engagement strategies; and (7) data management and integration. The new Strategic Plan is organized around these themes and details multiple objectives under each as well as actions to support the objectives. Many of the objectives and actions listed in this Strategic Plan are interconnected, reflecting the interdisciplinary nature of ocean acidification research and transdisciplinary Federal activities on it. For each action, it is indicated whether the action is new, revised, or the same as the action in the 2014 Strategic Plan. Information on federal spending on ocean acidification monitoring and research activities will be included in the final version of the plan; there is currently placeholder text, as public comment is not accepted on this portion of the plan.

NOS is developing a new strategic plan for 2024-2029. The strategic plan will define a future course as NOS continues to play a critical role in filling important needs for our national and coastal communities, including tackling the climate crisis, understanding and reversing declining ecosystem functions, and meeting the ever-expanding needs for authoritative environmental information.

This new plan also represents an opportunity for NOS to refresh our priorities, track our progress toward our goals, and align with the Department of Commerce (DOC) and NOAA strategic plans. Connecting these efforts, both across the agency and with partners, will allow us to achieve a greater impact through collaboration and information sharing.

We are seeking early input from the public as we begin to develop and define our long-term goals, objectives, and opportunities. In addition, we welcome your views on how external partnerships can help us better achieve our mission within NOS. Please consider the four priorities below and bring your ideas to the NOS Strategic Planning Listening Session on September 27, 2022. Participants are encouraged to sign-up to speak prior to the meeting by selecting the option to speak when you pre-register through this link https://noaabroadcast.adobeconnect.com/e31ixeyt0hw6/event/registration.html, or by contacting Michelle Rome by email at michelle.rome@noaa.gov or phone at 240-533-0669.

Conserve, Restore, Connect: America's ocean and coasts are facing significant and increasing pressures from human activity and climate change. NOS would like to hear your ideas on what is most needed to mitigate stressors, enhance degraded ecosystems, restore lost benefits, and provide value-added products and services that facilitate sustainable use, especially within marine protected areas. How can NOS data, observations, and scientific expertise be best utilized to achieve these aims? We'd also like to hear from you on how conserving and restoring ecosystems can address the causes and effects of the climate crisis.

Diversity, Equity, Inclusion, Justice, and Accessibility: Diversity, equity, inclusion, justice and accessibility are fundamental principles that underpin NOS values and how we conduct our mission, guiding our actions today and into the future. To ensure our mission benefits more communities across the nation and serves all people fairly and responsibly, NOS is interested in hearing your thoughts on how we can improve our efforts to equitably provide our data, products, and services. We'd also like your thoughts on how we can better leverage the various expertise and abilities of our external partners and additional organizations to attract, recruit and retain a diverse, highly-capable workforce, especially for future mission needs.

Coastal Resilience: U.S. coastal States, territories, communities, economies, and ecosystems are facing an array of event-based and long-term coastal hazards, including the impacts of changing water levels, land subsidence, marine debris, oil and chemical spills, harmful algal blooms, ocean acidification, and marine heat waves. Risk-informed decision making requires accurate and authoritative data, observations, modeling, mapping, and services that quantify and clearly communicate the drivers of coastal flood risk. NOS addresses this need by providing equitable access to actionable, authoritative data, products, and services relevant to coastal conditions and change that helps communities plan for both the near- and long-term resilience and adaptation of the nation's coasts in a changing climate. How can NOS coastal and ocean data, modeling, predictions, training, grants, tools, services, and products better support communities to prepare for increased near and long-term threats? How can we help ensure the equitable delivery of resilience information and resources to historically underserved communities?

New Blue Economy: NOS envisions a sustainable and equitable ocean and coastal economy that optimizes advances in science and technology to create value-added, data-driven economic opportunities and solutions to pressing societal needs. The New Blue Economy is focused on applying science and technology, especially the vast amounts of data and information they yield, to catalyze public and private sector innovation. By promoting U.S. development of new and improved data-derived products and services, NOS hopes to ensure that the nation has access to better tools to inform decision making across all Blue Economy sectors. How can NOS better support and accelerate the growth of the New Blue Economy? How can NOS support efforts to ensure there is a diverse and available talent pool and workforce that is essential to the success of the New Blue Economy?

The Secretary of Commerce is responsible for implementing the domestic obligations of the United States under the International Convention for the Regulation of Whaling, 1946. The U.S. IWC Commissioner has responsibility for the preparation and negotiation of U.S. positions on international issues concerning whaling and for all matters involving the IWC. The U.S. IWC Commissioner is staffed by the Department of Commerce and assisted by the Department of State, the Marine Mammal Commission, and other U.S. Government agencies.

Additional information about the IWC meeting, including a draft agenda for the meeting, is posted on the IWC Secretariat's website at https://iwc.int/events-and-workshops/iwc68.

NOAA will hold a public meeting to discuss the tentative U.S. positions for the October 2022 IWC meeting in Portorož, Slovenia. Any U.S. citizen with an identifiable interest in U.S. whale conservation and management policy may participate, but NOAA reserves the authority to inquire about the interests of any person who appears at the meeting and to determine the appropriateness of that person's participation. In particular, persons who represent foreign interests may not attend. Persons deemed by NOAA to be ineligible to attend will be asked to leave the meeting. These measures are necessary to limit statements to those conveying U.S. interests.

The September 27, 2022, meeting will be held at 1 p.m. EDT in a hybrid format. In-person attendees can join the meeting in the Fenton Room of the Silver Spring Civic Center, 1 Veterans Pl, Silver Spring, MD 20910. Persons may also attend virtually. Meeting access and conferencing platform information will be sent to those who register. To participate virtually, interested persons must register in advance via the following link: https://noaanmfs-meets.webex.com/noaanmfs-meets/j.php?RGID=r45c98c107d00773a8d62670ff3f302f7.

The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Madison Harris, Madison.Harris@noaa.gov or 202-480-4592, by September 21, 2022.

Title of Collection: Home Mortgage Disclosure Act (Regulation C).

OMB Control Number: 3170-0008.

Type of Review: Extension of a currently approved information collection.

Affected Public: Individuals and Households.

Estimated Number of Respondents: 136.

Estimated Total Annual Burden Hours: 1,472,000.

Abstract: The Home Mortgage Disclosure Act (HMDA) requires certain depository institutions and for-profit, non-depository institutions to collect, report, and disclose data about originations and purchases of mortgage loans. Additionally, these institutions must report mortgage loan applications that do not result in originations (for example, applications that are denied or withdrawn). The Bureau's Regulation C (12 CFR part 1003) implements HMDA. The purpose of the information collection is:

• To help determine whether financial institutions are serving the housing needs of their communities;

• To assist public officials in distributing public-sector investment so as to attract private investment to areas where it is needed; and

• To assist in identifying possible discriminatory lending patterns and enforcing antidiscrimination statutes.

The information collection will also assist the Bureau's examiners (and examiners of other Federal supervisory agencies) in determining whether the financial institutions they supervise comply with applicable provisions of HMDA.

Request for Comments: Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Bureau, including whether the information will have practical utility; (b) The accuracy of the Bureau's estimate of the burden of the collection of information, including the validity of the methods and the assumptions used; (c) Ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and/or included in the request for OMB's approval. All comments will become a matter of public record.

Title of Collection: Generic Information Collection Plan for Studies of Consumers Using Controlled Trials in Field and Economic Laboratory Settings.

OMB Control Number: 3170-0048.

Type of Review: Extension of a currently approved information collection.

Affected Public: Individuals and Households.

Estimated Number of Respondents: 44,150.

Estimated Total Annual Burden Hours: 33,100.

Abstract: Under the Dodd-Frank Wall Street Reform and Consumer Protection Act, the Bureau is tasked with researching, analyzing, and reporting on topics relating to the Bureau's mission including developments in markets for consumer financial products and services, consumer awareness, and consumer behavior. Under this generic information collection plan, the Bureau collects data through controlled trials in field and economic laboratory settings. This research is used for developmental and informative purposes to increase the Bureau's understanding of consumer credit markets and household financial decision-making. Basic research projects will be submitted under this clearance.

Request for Comments: Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Bureau, including whether the information will have practical utility; (b) The accuracy of the Bureau's estimate of the burden of the collection of information, including the validity of the methods and the assumptions used; (c) Ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and/or included in the request for OMB's approval. All comments will become a matter of public record.

Title; Associated Form; and OMB Number: Permit for Non-Army Agency Radiation Sources on Army Land; OMB Control Number 0702-0109.

Needs and Uses: The information collection requirement is necessary to regulate the use, storage, or possession of radiation sources by non-Army agencies (including their civilian contractors) on an Army installation. The non-Army applicant will apply by letter, email or facsimile with supporting documentation to the garrison commander through the appropriate tenant commander or garrison director.

The Army radiation permit application will specify the effective date and duration for the Army radiation permit and describe the purposes for which the Army radiation permit is being sought. The application will include identification of the trained operating personnel who will be responsible for implementation of the activities authorized by the permit and a summary of their professional qualifications; the point-of-contact name and phone number for the application; the applicant's radiation safety Standing Operating Procedures; storage provisions when the radiation source is not in use; and procedures for notifying the installation of reportable incidents/accidents.

Affected Public: Business or Other For-Profit; Not-For-Profit Institutions; State, Local, or Tribal Government.

Annual Burden Hours: 470.

Number of Respondents: 235.

Responses per Respondent: 1.

Annual Responses: 235.

Average Burden per Response: 2 hours.

Frequency: On occasion.

Title; Associated Form; and OMB Number: Qualitative and Quantitative Data Collection on Independent Review Commission Recommendation Evaluation; OMB Control Number 0704-HIRC.

Needs and Uses: This information collection activity provides a means to garner DoD-wide quantitative and qualitative data in support of the implementation and evaluation of the Secretary of Defense approved Independent Review Commission's (IRC) 82 recommendations. These information collections will be conducted by the OUSD (P&R), Office of General Counsel, Military Departments, Military Services, and/or National Guard Bureau (hereafter referred to as DoD). DoD will collect quantitative and qualitative data through data calls, surveys, interviews, site visits and other validated methods. Information collection efforts will align to the four IRC Lines of Effort (LOE): LOE 1—Accountability; LOE 2—Prevention; LOE 3: Climate and Culture; and, LOE 4: Victim Care and Support.

Affected Public: Individuals or households.

Annual Burden Hours: 45,000.

Number of Respondents: 45,000.

Responses per Respondent: 2.

Annual Responses: 90,000.

Average Burden per Response: 30 minutes.

Frequency: Annually.

A. Executive Summary

This notice is to advise all parties of a DHA demonstration project under the authority of Title 10, United States Code (U.S.C.), Section 1092, entitled “TRICARE Expansion of the Department of Defense and Department of Veterans Affairs Hearing Aid Procurement Model to Private Sector Care for Active Duty Service Members Receiving Care through the Supplemental Health Care Program and qualifying Prime Active Duty Family Members.” The demonstration will monitor whether cost variability can be decreased and efficiency increased using the DoD-VA HAP in the TRICARE MCSCs private sector care networks. The DoD Hearing Center of Excellence (HCE), in collaboration with the TRICARE Health Plan (THP) and the VA's Denver Logistics Center (DLC) and Central Audiology Office, will conduct and evaluate a demonstration of the use of the VA National Hearing Aid and Wireless Systems contract for the purchase of hearing aids and associated devices prescribed for ADSMs and qualifying Prime ADFMs seen by private sector care network audiologists in designated states. The proposed demonstration will help DHA assess whether use of these contracts will impact access to care, improve efficiency to care completion, decrease billing errors to increase cost avoidance for TRICARE and its beneficiaries, and improve patient experience in quality of care.

The demonstration will develop and evaluate a system for TRICARE MCSCs private sector care network audiologists to request hearing aids for ADSMs and qualifying ADFMs through a centralized audiology team supported by the DoD HCE. The devices will be ordered through the VA Remote Order Entry System (ROES), purchased from the VA via a DHA Military Interdepartmental Purchase Request (MIPR), and delivered to the prescribing audiologist's practice for fitting and dispensing to the beneficiary. This demonstration will integrate the Military and civilian health care systems per Section 705(c) of the National Defense Authorization Act for Fiscal Year 2017. Conducted under the purview of the DHA, it will be administered through the MCSCs (Health Net Federal Services (HNFS) and Humana Government Business (HGB), Inc. at time of publication) in three phases, applicable to ADSM beneficiaries receiving care authorized under the SHCP and qualifying Prime ADFMs. The DoD HCE will measure several outcome metrics, including but not limited to:

• Access to care for ADSMs and Prime ADFMs impact, positive or negative, by delivering care through this model, which will be measured through appointment data and shifts in number of providers available in demonstration states (ADSMs in California, Phase One; ADSMs in California and Texas, Phase Two, and qualifying ADFMs in California and Texas, Phase Three) vs. similarly sized non-demonstration states (Texas and Florida, Phase One; Florida, Phase Two, Florida; Phase Three).

Cost effectiveness will be measured by comparing:

• Financial costs incurred to THP for ADSMs and Prime ADFMs receiving audiology care in states excluded from Phases One, Two, and Three of the demonstration, to the cost incurred using this model, based on procedural coding and reimbursement data.

• Financial costs incurred to the VA under this model. The source of additional costs, opportunities for mitigation, and options for cost sharing between the Departments will be evaluated.

• Efficiency and convenience of the ordering system through the HCE centralized team and the VA DLC, by measuring the days elapsed between hearing aid evaluation visits, as billed, and the dispensing of hearing aids, as billed, in demonstration states vs non-demonstration states.

Patient satisfaction will be evaluated to determine positive or negative impacts of this program. Metrics will be based on patient questionnaire data through the Joint Outpatient Experience Survey (JOES) in Phase One, Two, and Three demonstration states compared to the JOES in non-demonstration states.

Hearing aids and associated devices for ADSMs seen at military medical treatment facilities (MTFs) are more economically procured through interagency collaboration between the DoD HCE and the VA DLC. For ADSMs and qualifying Prime ADFMs receiving private sector care, audiologists order hearing aids and associated devices for these TRICARE beneficiaries directly from companies at a significant markup over the VA contract price.

The purchase of the same devices for ADSMs treated at MTFs has been economically achieved through collaboration between the DoD HCE and VA per DoD policy established in 2013 to formalize the DoD-VA hearing aid procurement collaboration originating in the mid-1990s. In October 2014, the DoD issued policy authorizing referral of ADSMs to network audiologists when the ADSM either resides outside the catchment area or the specific audiology service is unavailable at their assigned MTF. Private sector care network audiologists prescribe and order hearing aid devices and accessories, when indicated for treatment, for their ADSM and qualifying ADFM patients, directly from companies at a significant markup over the VA contract price. In April 2018, the Office of the Secretary of Defense Chief Management Officer-led Reform Management Group endorsed exploration of a DoD-VA hearing aid procurement expansion initiative as a component of the Acting ASD (HA) approved THP Reform Implementation Plan.

Use of TRICARE private sector care providers for ADSMs is authorized by 10 U.S.C. 1074(c) (1), as implemented by 32 CFR 199.16 through the SHCP. Subject to special rules specified in 32 CFR 199.16(d) or waivers authorized in paragraph 199.16(f), neither of which apply to DoD providing hearing aids through the VA ROES, ADSM hearing aids are currently provided by TRICARE private sector care providers and reimbursed under the SHCP. Hearing aids for qualifying Prime ADFMs are currently provided by TRICARE private sector care providers and reimbursed under 32 CFR 199.4(e)(24). Authority under 10 U.S.C. 1092 will have to be exercised to authorize this hearing aid pilot as a demonstration to test the efficient and economical delivery of hearing aids through the TRICARE private sector care program.

The two-year demonstration will be conducted in three phases (Phase One and Two expanding annually; Phase Three six months after commencement of Phase Two) for ADSMs and qualifying Prime ADFMs meeting the criteria for profound hearing loss according to TRICARE law and policy to receive hearing aids and associated devices through private sector care audiologists in network in the state of California (Phase One), followed by the addition of ADSMs in the state of Texas (Phase Two), and qualifying Prime ADFMs in both states in Phase Three. Mandatory participation in utilizing the procedures established with TRICARE MCSCs will be required of all private sector care network audiologists prescribing hearing aids and associated devices for ADSMs and Prime ADFMs during the timeframe of this demonstration, in accordance with the provider's geographical area of state licensure during the applicable phase. It will require no changes to the manner in which audiology services, hearing aids, and their associated accessories are delivered to the beneficiary. Approximately one-third of the audiology private sector care network providers in the states of California and Texas bundle the cost of a hearing aid and related services, while two-thirds bill for the hearing aid devices, and separately bill for the related services ( e.g., hearing aid dispensing, fitting, and programming). Under this demonstration the providers will not be responsible for the cost of the hearing aids and associated devices that are a TRICARE benefit under the SHCP for ADSM beneficiaries, and special benefit for Prime ADFMs under 32 CFR 199.4(e)(24); therefore, those who bundle their care episodes will be required to unbundle their billing. The contract changes will apply to the audiologists in the HNFS and HGB TRICARE networks. The MCSCs will provide education to, and receive acknowledgement of acceptance by, all network audiologists regarding process and reimbursement differences prior to the effective implementation date of each phase of the demonstration.

Through the current process for ordering and reimbursement, the audiologist orders the prescribed hearing aids and associated accessories (hereafter referred to as “devices”) directly through the device manufacturer and delivers the hearing aids to the ADSM or ADFM. The audiologist then bills HGB or HNFS a bundled fee that includes a markup for the devices and the estimated cost of services that will be required over the life of the hearing aid ( e.g., follow-up visits, repairs). Through the DoD-VA HAP demonstration, the devices will be ordered by the dispensing audiologist through audiologists at the HCE, to the DLC, which processes all VA contract orders for these devices. During this demonstration, the HCE audiologists will use the existing centralized MIPR within DHA to commit funds to the order in the ROES. The devices will then be delivered directly to the dispensing audiologist's practice in order to dispense to the beneficiary and continue follow-up care. HGB and HNFS will continue to reimburse the in-network audiologists for all covered benefits for eligible ADSMs and Prime ADFMs. For all hearing aid services, prescribed Common Procedural Terminology (CPT) code will be provided for use by the audiologists to ensure appropriate reimbursement for the services rendered. Health care received within the demonstration will match the current TRICARE PRIME benefit for ADSMs authorized through the SHCP, and Prime ADFMs authorized in the Prime benefit.

The DHA will proactively educate audiologists, beneficiaries, and other stakeholders about this change through the TRICARE MCSCs. Provider engagement will commence following the publication of this notice. Materials will explain the demonstration benefit and the process changes to the network audiologists and beneficiaries as applicable.

This demonstration will assist the DHA in determining the program's future course of action based on an in-depth analysis. This will include at a minimum: determination if the use of the existing VA hearing aid purchase contract by DoD is an effective approach for ADSMs and qualifying Prime ADFMs who receive hearing aid services in the TRICARE network; measurement of the program's effectiveness in reducing cost variation; the maintenance of access to care; Defense Health Program cost avoidance, with measured cost increases for the VA; and subjective quality of care assessment from patient feedback. Monthly reports and a full analysis of the demonstration outcomes will be conducted throughout and for each phase of the demonstration to monitor the access to care, financial costs incurred, and program effectiveness.

Costs and performance will be analyzed by the DoD HCE and compared to previous periods of the demonstration. Additionally, to measure overall impact, the California and Texas markets will be compared to markets of similar size, such as Florida, taking into account previously fluctuating trends in all three markets with regard to the number of network audiologists, financial costs incurred, and number of ADSM and Prime ADFM patients fit with these devices.

Access to care will be measured using encounter data, showing the time between the hearing aid evaluation and the dispensing of the devices to the patient, as billed through CPT Codes, comparing the average time per patient in California and Texas to average time per patient in the non-demonstration states of Texas and Florida (Phase One), and Florida (Phases Two and Three). Cost effectiveness will be measured by comparing: (1) financial costs incurred to DHP for ADSMs receiving audiology care in states excluded from Phases One, and Two, and ADFM in states excluded from Phase Three of the demonstration, to the cost incurred using this model, based on procedural coding and reimbursement data, and; (2) financial costs incurred to the VA under this model. The source of additional costs, opportunities for mitigation, and options for cost sharing between the Departments will be evaluated. Program effectiveness will be measured by the established workflow for the receipt of orders by the HCE audiologists, the continued service of the contracted audiologists ( i.e., audiologists elected to continue as network audiologists even after implementation of this process), time between ordering and dispensing the device, and decrease in costs of billed devices. Quality of care will be assessed through patient satisfaction data from the JOES.

The DHA Director reserves the right to terminate the demonstration early if the enrollment, cost, or quality do not support continuation of the demonstration. Based on the success of this program within MTFs and the VA Community Care Network, DHA will seek regulatory action to implement the program in the TRICARE private sector program concurrent with the demonstration. If the demonstration is successful, the DHA Director may recommend extension of the demonstration pending regulatory action. If regulatory action is successful and accomplished prior to the demonstration completion, the DHA Director reserves the right to terminate the demonstration and implement the program throughout the TRICARE private sector program.

Under this demonstration the providers will not be responsible for the cost of the hearing aids and associated devices that are a TRICARE benefit under the SHCP for ADSM beneficiaries and Prime benefit for qualifying Prime ADFMs; therefore, those who bundle their care episodes will be required to unbundle their billing. The contract changes will apply to the audiologists in MCSC TRICARE networks in the demonstration states. MCSCs will continue to reimburse the in-network audiologists for all covered benefits for eligible ADSMs and qualifying Prime ADFMs. For all hearing aid services, prescribed CPT codes will be provided for use by the audiologists to ensure appropriate reimbursement for the services rendered.

The demonstration is effective January 1, 2023, continuing for a duration of two years: Phase One (ADSM in California) has a target effective date of care delivery of January 1, 2023; Phase Two (ADSM in Texas) has a target effective date of care delivery of January 1, 2024; and Phase Three (ADFMs in California and Texas) has a target date of delivery of care of July 1, 2024. If successful, the Director, DHA, may recommend extension of the demonstration until appropriate necessary action has been taken to implement the program in the TRICARE private sector care program.

Title; Associated Form; and OMB Number: Department of Defense Application for Priority Rating for Production or Construction Equipment; DD Form 691; OMB Control Number 0704-0055.

Needs and Uses: Executive Order 12919 delegates authority to DoD to require certain contracts and orders relating to approved Defense Programs to be accepted and performed on a preferential basis. This program helps contractors acquire industrial equipment in a timely manner, thereby facilitating development and support of weapons systems and other important Defense Programs.

Affected Public: Business or other For-Profit; Not-for-Profit Institutions.

Annual Burden Hours: 610.

Number of Respondents: 610.

Responses per Respondent: 1.

Annual Responses: 610.

Average Burden per Response: 1 hour.

Frequency: On occasion.

Purpose: In accordance with the Government in the Sunshine Act (Sunshine Act), Public Law 94-409, as amended (5 U.S.C. 552b), the U.S. Election Assistance Commission (EAC) will conduct a virtual workshop in partnership with the National Institute of Standards and Technology (NIST) on “The Path to End to End (E2E) Protocols for Voting Systems.”

Agenda: The EAC, in collaboration with NIST, is initiating a process to publicly solicit, evaluate, and approve protocols used in end to end (E2E) cryptographically verifiable voting systems for conformance to the recently revised Voluntary Voting System Guidelines, Version 2.0 (VVSG 2.0). During this two-day virtual workshop, multiple panel groups will discuss the plan and further develop the protocol requirements and evaluation criteria.

Panels will include state and local election officials, representatives from federal agencies, staff from voting system manufacturers and voting system test labs, and subject matter experts. Topics addressed in these panels include integrity and voter confidence, security, accessibility and human factor considerations, and testing and implementation of E2E in voting systems. There will also be a keynote address on E2E in voting systems.

The workshop is open to the public but registration is required so that webinar connection details can be shared with attendees. Questions about registration can be directed to e2einfo@eac.gov.

The full agenda will be posted in advance on the EAC website: https://www.eac.gov/events/2022/10/06/path-end-end-e2e-protocols-voting-systems and at https://www.nccoe.nist.gov/get-involved/attend-events/path-end-end-e2e-protocols-voting-systems.

Following the event, a recording will be posted on the EAC's website: https://www.eac.gov/events/2022/10/06/path-end-end-e2e-protocols-voting-systems.

Background: On February 10, 2021, the EAC Commissioners unanimously approved the most recent iteration of federal voting system standards, VVSG 2.0.

Principle 9, “Auditable,” of VVSG 2.0 states that voting systems must be auditable and enable evidence-based elections. This principle is supported by the concept of software independence (SI), meaning that an undetected error or fault in the voting system's software is not capable of causing an undetectable change in election results. The VVSG 2.0 requirements specify that E2E cryptographic protocols used in voting systems must be evaluated and approved through a public process established by the EAC, prior to the E2E verifiable voting system being submitted to the EAC's Testing and Certification Program. This workshop is to discuss further development of requirements and evaluation criteria for the public E2E protocol evaluation process.

Status: This meeting will be open to the public.

On June 6, 2018, FERC confirmed and approved Rate Schedule BCP-F10, under Rate Order No. WAPA-178, on a final basis through September 30, 2022. 1 Western Area Power Administration (WAPA) published a Federal Register notice (Proposed FRN) on April 13, 2022 (87 FR 21881), proposing to renew the existing formula rates for electric service as Rate Schedule BCP-F11 and to calculate the FY 2023 base charge and rates under Rate Schedule BCP-F11. The Proposed FRN also initiated a public consultation and comment period and set forth the date and location of the public information and public comment forums.

Consistent with the formulas set forth in the BCP ESC, WAPA is renewing the formula rates for electric service as Rate Schedule BCP-F11, which would be effective October 1, 2022, through September 30, 2027, pending confirmation and approval by FERC on a final basis or until superseded. The formula rates will continue to provide sufficient revenue to recover all annual costs, including interest expense. Rate Schedule BCP-F11 and the BCP ESC require WAPA to calculate the annual base charge and rates for the next fiscal year before October 1 of each year based on formulas that are set for a five-year period.

WAPA is establishing rates for BCP electric service in accordance with section 302 of the Department of Energy (DOE) Organization Act (42 U.S.C. 7152). This provision transferred to, and vested in, the Secretary of Energy certain functions of the Secretary of the Interior, along with the power marketing functions of Bureau of Reclamation. Those functions include actions that specifically apply to the BCP.

Pursuant to the BCP ESC, the renewed rate formula under Rate Schedule BCP-F11 and calculated base charge and rates for FY 2023 shall become effective, provisionally, upon approval by the Deputy Secretary of Energy subject to final approval by FERC. Under the DOE Organization Act, the Secretary of Energy holds plenary authority over DOE affairs with respect to the Power Marketing Administrations, and the Secretary of Energy may therefore exercise the Deputy Secretary's contractual authority in this context. By Delegation Order No. S1-DEL-RATES-2016, effective November 19, 2016, the Secretary of Energy delegated: (1) the authority to develop power and transmission rates to the WAPA Administrator; (2) the authority to confirm, approve, and place such rates into effect on an interim basis to the Deputy Secretary of Energy; and (3) the authority to confirm, approve, and place into effect on a final basis, or to remand or disapprove such rates, to FERC. Based upon the governing terms of the existing BCP ESC, the Deputy Secretary will approve the formula rates and the FY 2023 base charge and rates for BCP electric service. This rate action is issued under the Delegation Order and DOE's procedures for public participation in rate adjustments set forth at 10 CFR parts 903 and 904. 2

Following review of WAPA's proposal, I hereby confirm, approve and place Rate Order No. WAPA-204, which provides the formula rates for BCP electric service and calculates the base charge and rates for FY 2023, into effect on an interim basis. WAPA will submit Rate Order No. WAPA-204 to FERC for confirmation and approval on a final basis.

The Boulder Canyon Project (BCP) formula rates for electric service and fiscal year (FY) 2023 base charge and rates are established following section 302 of the Department of Energy (DOE) Organization Act (42 U.S.C. 7152). 1 This provision transferred to, and vested in, the Secretary of Energy certain functions of the Secretary of the Interior, along with the power marketing functions of the Bureau of Reclamation (Reclamation). Those functions include actions that specifically apply to the BCP.

Pursuant to the BCP Electric Service Contract (ESC), the renewed rate formula under Rate Schedule BCP-F11 and calculated base charge and rates for FY 2023 shall become effective, provisionally, upon approval by the Deputy Secretary of Energy subject to final approval by the Federal Energy Regulatory Commission (FERC). Under the DOE Organization Act, the Secretary of Energy holds plenary authority over DOE affairs with respect to the Power Marketing Administrations, and the Secretary of Energy may therefore exercise the Deputy Secretary's contractual authority in this context. By Delegation Order No. S1-DEL-RATES-2016, effective November 19, 2016, the Secretary of Energy delegated: (1) the authority to develop power and transmission rates to the Administrator of Western Area Power Administration (WAPA); (2) the authority to confirm, approve, and place such rates into effect on an interim basis to the Deputy Secretary of Energy; and (3) the authority to confirm, approve, and place into effect on a final basis, or to remand or disapprove such rates, to FERC. This Rate Order is issued under the Delegation Order and DOE's procedures for public participation in rate adjustments set forth at 10 CFR parts 903 and 904, subject to final approval by FERC.

Rate Schedule BCP-F11 will take effect on October 1, 2022, and will remain in effect through September 30, 2027, and the BCP FY 2023 base charge and rates will be effective October 1, 2022, and remain in effect through September 30, 2023, pending confirmation and approval by FERC on a final basis or until superseded.

The notice of the proposed renewal of formula rates in Rate Schedule BCP-F11 and the proposed FY 2023 base charge and rates for electric service were published consistent with procedures set forth in 10 CFR part 903 and 10 CFR part 904. Following are the steps WAPA took to involve contractors and other interested parties in the rate process:

1. On April 13, 2022, a Federal Register notice (87 FR 21881) (Proposed FRN) announced the proposed renewal of the formula rates and the proposed FY 2023 base charge and rates and launched the 90-day public consultation and comment period.

2. On April 13, 2022, WAPA notified contractors and interested parties of the proposed rates and provided a copy of the published Proposed FRN.

3. On May 13, 2022, WAPA held a public information forum (PIF) via video conference. Reclamation and WAPA's representatives explained the proposed formula rates for electric service and the proposed FY 2023 base charge and rates and answered questions.

4. On June 8, 2022, WAPA posted responses to questions from the PIF about Renewable Energy Certificates (RECs) and to a letter received with additional questions and comments about RECs.

5. On June 13, 2022, WAPA held a public comment forum (PCF) via video conference to provide an opportunity for contractors and other interested parties to comment for the record.

6. WAPA provided a website that contains important dates, correspondence, presentations, comments, responses, FRNs, and other information about this rate process. The BCP website is located at www.wapa.gov/regions/DSW/Rates/Pages/boulder-canyon-rates.aspx.

7. During the 90-day consultation and comment period, which ended on July 12, 2022, WAPA received four oral comments and four written comments. WAPA's responses to comments received prior to the PCF were posted on the BCP website. WAPA's responses to comments received during or after the PCF are included below. All comments have been considered in the preparation of this Rate Order.

Oral comments were received from the following organizations:

Written comments were received from the following organizations, some of which submitted comments jointly:

The comments received during or after the PCF have been paraphrased herein, where appropriate, without compromising the meaning of the comments.

Comment: Commenter (1) thanked Reclamation and WAPA for participation in the BCP Engineering and Operations Committee (E&OC), (2) agreed with additional consultation at future E&OC meetings to address drought impacts, and (3) stated the drought analysis developed by Reclamation and WAPA has helped to forecast and understand the drought impacts to hydropower customers of Federal projects in the Lower Colorado River Basin.

Response: Reclamation and WAPA appreciate the positive feedback and will continue to work with customers as hydrological conditions change. To help the contractors with future planning specific to BCP, an E&OC work group will be formed to study the impacts of the continuing drought.

Comment: Commenters stated they understood from the posted PIF responses that REC revenue projections for FY 2023 will be removed from the FY 2023 rates and supported this interim solution. They encouraged consultation with contractors on future treatment of REC revenues.

Response: This is correct; the $800,000 projection for REC revenue previously included in the proposed FY 2023 base charge calculation has been removed. WAPA will work with the contractors and discuss options to directly provide benefits to those contractors who do not claim their RECs.

Comment: Commenter (1) thanked Reclamation and WAPA for the opportunity to participate in developing the work plans and budget for the BCP and for the reduction in the base charge for FY 2023, (2) commended Reclamation and WAPA and the committees involved that support the goals in the BCP Implementation Agreement between Reclamation, WAPA, and the contractors, and (3) was appreciative that a work group is being established for contingency planning related to the drought.

Response: Reclamation and WAPA appreciate the comment and will continue to work collaboratively with the contractors on contingency planning for the drought, provide information as it is available, and continue to ensure rates are the lowest possible consistent with sound business principles.

Comment: Commenter stated the drought impact analysis has helped to provide an understanding of the water restrictions in response to the ongoing drought and the resulting generation impacts. Commenter agrees with having additional consultation at future E&OC meetings to address the continuing drought and its impact to the future base charge and rates.

Response: Reclamation and WAPA will continue to work with contractors on the impacts of the ongoing drought and a work group will be formed to study the impacts as hydrological conditions change.

Hoover Dam, 2 authorized by the Boulder Canyon Project Act of 1928 (45 Stat. 1057, December 21, 1928), sits on the Colorado River along the Arizona-Nevada border. The Hoover Dam power plant has 19 generating units (two for plant use) and an installed capacity of 2,078.8 megawatts (4,800 kilowatts for plant use). In collaboration with Reclamation, WAPA markets and delivers hydropower from the Hoover Dam power plant through high-voltage transmission lines and substations to Arizona, Southern California, and Southern Nevada.

The base charge recovers an annual revenue requirement that includes projected costs for investment repayment, interest, operations, maintenance, replacements, payments to States, and Hoover Dam visitor services. Non-power revenue projections from water sales, the Hoover Dam visitor center, ancillary services, and late fees help offset the projected costs. Hoover Dam power contractors are billed a percentage of the base charge in proportion to their power allocation. Unit rates are calculated for comparative purposes but are not used to determine the charges for service.

While the formula rates remain unchanged, the FY 2023 base charge for BCP electric service is decreasing from $67.4 million in FY 2022 to $66.8 million in FY 2023, a 0.8-percent decrease. Working together, Reclamation and WAPA conducted a mid-year review to lessen the financial impact of the drought to the rates and reduced costs by $2.1 million from the initial proposal in the Proposed FRN.

Reclamation's FY 2023 budget is increasing $2.9 million from $81.7 million to $84.7 million, a 3.6-percent increase from FY 2022. Reflected in this budget, operations and maintenance (O&M) costs are increasing $3.4 million primarily due to a higher overhead rate for salaries attributed to a reorganization and increased staffing needs to improve cybersecurity; an increase in services for IT support and equipment; trash disposal contract costs; fabrication of elevator doors; ammunition for security forces; and anticipated costs for the Workman's Compensation Program. Visitor services costs are increasing $490,000 due to higher projected contract costs for janitorial, memorabilia, ticketing, and trash disposal services. The increase for Reclamation is offset by a $1.1 million decrease in replacement costs primarily due to Reclamation's effort to level extraordinary maintenance project expenses. This results in reduced annual costs for the control center renovation project and the replacement of the A9 wicket gates, visitors center escalator, and wastewater treatment facility.

WAPA's FY 2023 budget is decreasing $438,000 from $9.2 million to $8.7 million, a 4.8-percent decrease from FY 2022. Reflected in this budget, WAPA's O&M costs are decreasing by $842,000 due to a shift from O&M to capital work. The decreasing O&M costs are offset primarily by a $380,000 increase in WAPA's replacement budget for breaker and relay replacements in the Mead Substation 69-kilovolt yard.

Costs for Reclamation and WAPA are offset by a slight increase of $68,000 in non-power revenue projections, due to a higher estimate for ancillary services revenues. Prior-year carryover is projected to be $5.6 million, a $3 million increase from FY 2022. This increase in carryover primarily is due to the $1.8 million reduction of FY 2022 O&M costs made during the mid-year review and the addition of $1 million in non-power revenues from the FY 2022 sale of RECs from FY 2021 and earlier years. The sale of these RECs occurred prior to contractors expressing a preference for a different treatment of revenue from RECs.

Although the base charge is decreasing by 0.8 percent, the rates calculated for comparative purposes are increasing 6.9 percent and 8.7 percent due to reduced energy and capacity from the ongoing drought in the Colorado River Basin. Reclamation and WAPA will continue to work collaboratively to lessen the impact of the drought in future years.

WAPA's Administrator certified that the formula rates for BCP electric service under Rate Schedule BCP-F11 result in the lowest possible rates consistent with sound business principles, and the calculated FY 2023 base charge and rates under Rate Schedule BCP-F11 are the lowest possible rates consistent with sound business principles. The formula rates and base charge and rates were developed following administrative policies and applicable laws.

Information about this rate adjustment, including studies, comments, letters, memorandums, and other supporting materials that were used to develop the formula rates for electric service and the base charge and rates are available for inspection and copying at the Desert Southwest Customer Service Regional Office, located at 615 South 43rd Avenue, Phoenix, Arizona. Many of these documents are also available on WAPA's BCP website at www.wapa.gov/regions/DSW/Rates/Pages/boulder-canyon-rates.aspx.

WAPA has determined that this action fits within the following categorical exclusions listed in appendix B to subpart D of 10 CFR 1021.410: B4.3 (Electric power marketing rate changes) and B4.4 (Power marketing services and activities). 3 Categorically excluded projects and activities do not require preparation of either an environmental impact statement or an environmental assessment. Specifically, WAPA has determined that this rulemaking is consistent with activities identified in B4, Categorical Exclusions Applicable to Specific Agency Actions ( see 10 CFR part 1021, appendix B to subpart D, part B4). A copy of the categorical exclusion determination is available on WAPA's website at www.wapa.gov/regions/DSW/Environment/Pages/environment.aspx.

WAPA has an exemption from centralized regulatory review under Executive Order 12866; accordingly, no clearance of this notice by the Office of Management and Budget is required.

The BCP formula rates for electric service in Rate Schedule BCP-F11 and the FY 2023 base charge and rates under Rate Schedule BCP-F11 herein confirmed, approved, and placed into effect on an interim basis, together with supporting documents, will be submitted to FERC for confirmation and final approval.

In view of the above and under the authority delegated to me, I hereby confirm, approve, and place into effect, on an interim basis, the BCP formula rates for electric service in Rate Schedule BCP-F11 and the FY 2023 base charge and rates under Rate Schedule BCP-F11. The rates will remain in effect on an interim basis until: (1) FERC confirms and approves them on a final basis; (2) subsequent rates are confirmed and approved; or (3) such rates are superseded.

This document of the Department of Energy was signed on September 12, 2022, by David M. Turk, Deputy Secretary, 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 first day of the first full billing period beginning on or after October 1, 2022, and extending through September 30, 2027, or until superseded by another rate schedule, whichever occurs earlier.

In the marketing area serviced by the Boulder Canyon Project.

To power supplied by the Boulder Canyon Project through one meter, at one point of delivery, unless otherwise provided by contract.

Alternating current at 60 hertz, three-phase, delivered and metered at the voltages and points established by contract.

The charge paid by each contractor for their allocated capacity and firm energy based on the annual revenue requirement. The base charge shall be composed of a capacity component and an energy component:

Capacity Charge: Each month WAPA shall bill each contractor for a capacity charge equal to one-twelfth (1/12) of the capacity dollars multiplied by each contractor's contingent capacity percentage as provided by contract.

Energy Charge: Each month WAPA shall bill each contractor for an energy charge equal to that period's monthly energy ratio, multiplied by the contractor's energy dollars as provided by contract.

Energy: Shall be equal to the annual energy dollars divided by the lesser of the total master schedule energy or 4,501 megawatt-hours. This rate is applied to excess energy, unauthorized overruns, and water pump energy.

Capacity: Shall be equal to the annual capacity dollars divided by 2,074 megawatt-hours. This rate is applied to unauthorized overruns.

Within ninety (90) days after the end of the fiscal year, an energy rate shall be calculated. For any rate year in which energy deemed delivered is greater than 4,501 megawatt-hours, WAPA shall apply the calculated energy rate to each contractor's energy deemed delivered to determine the contractor's actual energy charge. A credit or debit shall be established for each contractor based on the difference between the contractor's energy dollars and the contractor's actual energy charge, to be applied in the month following the calculation or as soon as possible thereafter.

The Contribution Charge is 4.5 mills for each kilowatt-hour measured or scheduled to an Arizona purchaser and 2.5 mills for each kilowatt-hour measured or scheduled to a California or Nevada purchaser, except for purchased power.

For each billing period in which there is a contract violation involving an unauthorized overrun of contractual power obligations, such overrun shall be billed at ten (10) times the forecast energy rate and forecast capacity rate. The Contribution Charge shall also be applied to each kilowatt hour of overrun.

None.

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

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

Abstract: The State Review Framework is an oversight tool designed to assess state performance in enforcement and compliance assurance. The Framework's goal is to evaluate state performance by examining existing data to provide a consistent level of oversight and develop a uniform mechanism by which EPA Regions, working collaboratively with their states, can ensure state environmental agencies consistently implement the national compliance and enforcement program to meet agreed-upon goals. Furthermore, the Framework is designed to foster dialogue on enforcement and compliance performance between states to enhance relationships and increase feedback, which will in turn lead to consistent program management and improved environmental results. This request will allow OECA to review and collect information from state and local agency enforcement and compliance files, to support the State Review Framework implementation from FY 2024 to FY 2027. It will also allow EPA to make inquiries to assess the State Review Framework process, including consistency achieved among the EPA Regions and states, resources required to conduct reviews, and overall effectiveness of the program.

Form Numbers: None.

Respondents/affected entities: States, localities, and territories.

Respondent's obligation to respond: Required as part of program authorization under the Clean Water, Clean Air, Safe Drinking Water and Resource Conservation and Recovery Acts.

Estimated number of respondents: 213 (total).

Frequency of response: Once every 5 years.

Total estimated burden: 12,993 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total estimated cost: $546,729 (per year).

Changes in Estimates: There is an increase in total estimated response burden hours from 218 to 305 per respondent due to the addition of the safe drinking water act enforcement review pilot, which wasn't captured in the previous ICR. This pilot isn't formally part of the SRF, but the agency believes this ICR is an appropriate forum to collect input, due to their similarities in workload and purpose. At the conclusion of the pilot, the agency will review the program and if necessary, revise this ICR. In addition, there is an increase in the number of respondents from 54 to 213 due to inclusion of all media (CAA, CWA, RCRA and SDWA) for 50 states and 4 territories, and 14 local air districts. Previous ICR's included a single response for each state/territory, whereas this ICR utilized a different methodology to capture the burden more accurately. The burden estimates for CAA, CWA and RCRA are unchanged.

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

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

Abstract: Section 608 of the Clean Air Act (CAA), also known as the National Recycling and Emission Reduction Program (the Program), directs the Environmental Protection Agency (EPA) to issue regulations governing the use of ozone-depleting substances (ODS), including chlorofluorocarbons (CFCs) and hydrochlorofluorocarbons (HCFCs), during the maintenance, service, repair, or disposal of air-conditioning and refrigeration appliances. Section 608 also prohibits knowingly venting or releasing ozone-depleting and substitute refrigerants in the course of maintaining, servicing, repairing, or disposing of appliances or industrial process refrigeration except for de minimis releases associated with good faith attempts to recycle or recover refrigerants. The regulations require persons servicing refrigeration and air-conditioning appliances to follow certain service practices that reduce emissions of refrigerants. The regulations also establish certification programs for technicians, recovery/recycling equipment, and refrigerant reclamation. In addition, EPA requires that refrigerants contained in appliances be removed prior to disposal of the appliances and that all refrigeration and air-conditioning appliances be provided with a servicing aperture that facilitates recovery of the refrigerant. The Agency requires that substantial refrigerant leaks in appliances containing ozone-depleting refrigerant be repaired when they are discovered.

Form Numbers: 5900-404, 5900-405, 5900-407.

Respondents/affected entities: Entities required to comply with reporting and recordkeeping requirements include technicians; technician certification programs; refrigerant wholesalers; refrigerant reclaimers; refrigerant recovery equipment certification programs; certain refrigeration and air-conditioning equipment owners and/or operators; and other establishments that perform refrigerant removal, service, or disposal.

Respondent's obligation to respond: Mandatory (40 CFR part 82, subpart F).

Estimated number of respondents: 572,727.

Frequency of response: The frequency of responses varies from once a year to daily.

Total estimated burden: 425,514 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total estimated cost: $31,432,946 (per year), There are no estimated annualized capital or operation and maintenance costs associated with the reporting or recordkeeping requirements.

Changes in Estimates: There is a decrease of 47,837 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This decrease is due to adjusted respondent estimates for appliance leak repair and retrofit or retirement plan extension requests based on recently available industry data and reported activity.

In accordance with 5 U.S.C. 4314(c)(4), the names and position of the EEOC PRB members are set forth below:

Purpose

To obtain relevant information from domestic commercial PV panel and system component manufacturers and resellers, PV panel purchasers and installers, and renewable electricity providers, including small businesses.

The information received will help GSA develop a procurement strategy, to potentially include a procurement standard for use in future solicitations where the use of PV panels and components are required.

GSA intends to use the information generated from this Request for Information (RFI) in support of the goals expressed in section 203 of Executive Order (E.O.) 14057, Catalyzing Clean Energy Industries and Jobs Through Federal Sustainability (December 8, 2021), as well as the White House Fact Sheet, titled President Biden Takes Bold Executive Action to Spur Domestic Clean Energy Manufacturing (June 6, 2022).

GSA seeks to learn more from industry regarding the use of domestically manufactured PV panels and components in contract types including: Power Purchase Agreements (PPA), Energy Savings Performance Contracts (ESPC), Utility Energy Service Contracts (UESC), solar array development contracts, and other acquisition vehicles depending on future need. This RFI is also being issued in anticipation of future projects that may be funded by the Inflation Reduction Act (IRA) (Pub. L. 117-169). GSA is particularly interested in the impacts of this initiative on underserved or disadvantaged communities.

This RFI is for general fact-gathering purposes. Interested parties will not be reimbursed for any costs related to providing information in response to this RFI. The Government does not intend to award a contract on the basis of this RFI.

In submitting your response, please number your answers with which question you are answering, for example: Requested Information Specific to Manufacturing 2(a)(i).

For purposes of organizing the data received, please provide the following information in your response:

• What is your company or organization name, point of contact, telephone number, and email address?

• What is the nature of your company or organization?

○ Are you a solar panel or component provider, manufacturer, re-seller, or retailer (for residential, commercial, or utility scale); developer, utility company, or other (specify)?

○ Describe your business in a few sentences, to include how long your company or organization has provided these services.

• What is your company or organization's primary North American Industry Classification System (NAICS) code?

○ The NAICS code for photovoltaic cell manufacturing is 334413, Semiconductor and Related Device Manufacturing. If you operate under a different NAICS code for other elements of this RFI please provide your primary NAICS code.

• With your primary NAICS code in mind, what is your company's size status, is your company a large or small business?

○ As defined by the Small Business Administration, the size standard to qualify as a small business for NAICS code 334413 is fewer than 1,250 employees.

○ What, if any, small business socio-economic categories apply to your business, such as Small Disadvantaged Business, Woman-Owned Small Business, Veteran-Owned Small Business, Service-Disabled Veteran-Owned, or Historically Underutilized Business Zone?

1. Is your company an established PV panel or component manufacturer (defined for the purposes of the RFI as the panel or component being in commercial production for 2 or more years)?

2. Does your company or organization manufacture PV panels or system components for the arrays domestically?

a. If yes, please provide a brief description to include the place of manufacture and where in the supply chain your product falls, i.e., do you manufacture a component or assemble the final panel system or components?

i. What is your company's production capacity of domestically manufactured solar panels?

ii. Are you anticipating an increase or decrease in production capacity in the next 10-year timeframe? Why or why not?

b. From which countries do you or your suppliers source the majority of the raw materials for the PV panels or components?

i. Please provide the countries of origin for each major component if purchased outside of the U.S.

ii. Please describe current traceability tools and how effective they are.

iii. Has your due diligence in monitoring your supply chain changed as a direct result of the Uyghur Forced Labor Prevention Act (UFLPA)? Is implementation of the UFLPA a help or hindrance to domestic manufacturing?

iv. Do you have capacity to trace and certify that your products meet the component test for manufactured goods of 55% called out in the Infrastructure Investment and Jobs Act (IJA) and 55%, incrementally increasing to 75% over time, for federal procurements?

v. With recent legislative changes, are there now more mechanisms to trace the country of origin for the components? Please describe.

3. Has your company experienced availability, quality, workability, or durability challenges with PV panels and/or components?

a. Have you seen any differences in the availability, quality, workability, or durability between PV panels manufactured foreignly or domestically?

b. Are there good examples of quality assurance and quality control procedures/programs for PV panels or components that you trust?

4. If your company has been in panel/component commercial production for fewer than two years, please disclose which part of the domestic PV supply chain your company will support.

5. It is our understanding that there are primarily two types of panels commercially available: crystalline silicon and tellurium. Is your firm developing or close to commercializing new panel technology outside of these two types?

6. Please provide as many details as you can in response to the questions listed below:

a. What is the rated wattage of your PV panels?

b. What is the efficiency rating of your PV panels?

c. What is the weight of your PV panels?

d. What type of warranty do you offer for your PV panels?

e. What is the product warranty period for your PV panels?

f. What is the power warranty after 25 years of operation?

g. Do you have embodied carbon product declarations (EPDs) for the panels that you produce or sell? If yes, how is this calculated and are shipping logistics included?

h. Do you perceive a difference in efficiency expectations between residential, commercial, and utility-scale PV panels, and if yes what is the difference?

7. What steps would be needed to increase circularity (or recyclability) in the PV manufacturing sector?

a. What are roadblocks to circularity/recyclability in the PV industry and are those barriers alleviated with federal subsidies?

b. Describe your recycling process for PV panels or its components (if any). What technology is needed in order to improve on recycling?

8. Is your company or organization taking action to source domestically manufactured PV panels and/or components?

a. If yes, what actions are you taking and why are you taking those actions?

9. Other than the price, are there other obstacles to sourcing domestically made PV panels and/or components?

a. Are there obstacles to identifying skilled labor to complete the installations?

10. Has your company or organization experienced availability, quality, workability, or durability challenges with PV panels and/or components?

a. Have you seen any differences between foreign and domestic products for PV panels and system components?

11. If you are a developer who anticipates construction of new solar generation facilities in the next five years, what barriers can you identify to using domestically manufactured PV panels and/or components?

a. Are there state laws or regulations preventing energy providers from requiring domestically made PV panels and components?

12. What opportunities, if present, would encourage use of domestically manufactured PV panels and/or components for such generation facilities?

a. Is your company aware of any disruptive technologies that could render current PV panels and/or components, or system designs outdated or incompatible with existing systems?

13. What are the technical, economic, logistical, or regulatory obstacles that exist to domestically manufacturing PV panels or purchasing renewable energy as a commodity? Does the IRA resolve any of these obstacles for your company?

14. How will the IRA and potentially more federal opportunities for use of domestically manufactured PV panels or components help you expand or increase your rate of growth? Are there other initiatives or factors that impede or spur growth in this area? How will the IRA impact the purchase of power versus the PV systems themselves?

15. If you are not a manufacturer, to what extent do you acquire PV panels systems or components from domestic sources? Do you expect your purchasing behavior will change as a result of federal subsidies?

16. What would be the likely impacts of the Government requiring in its procurements that solar energy under such contracts be generated using domestically manufactured PV panels or components?

a. What are the risks/downsides?

b. What are the opportunities/upsides?

c. If you are a developer, would such a requirement change your willingness to participate in future federal opportunities?

17. Other than establishing a requirement, what steps could the Government take to use federal acquisition to leverage domestic PV panel or component manufacturing?

18. If the Government were to pursue developing a procurement standard for domestically manufactured PV panels or components, what key elements should be contained in that standard to encourage domestic manufacturing?

19. What components in PV panels would be difficult to source domestically?

a. Do different components in PV panels need different timeframes for being domestically sourced without difficulty?

20. There is an Electronic Product Environmental Assessment Tool (EPEAT) ecolabel for PV panels and inverters. Please share your company's plan/timeline to get your PV panels EPEAT registered.

a. What percentage of the components of your EPEAT registered solar panels do you anticipate would be domestically sourced?

b. How does your company ensure that your solar supply chain does not utilize forced labor? Will your company's supply chain be impacted by the recently passed Uyghur Forced Labor Prevention Act?

c. What steps can the Government take to further protect your supply chain from forced labor concerns?

d. If the EPEAT criteria for PV panels and/or components were updated to address forced labor within the supply chain, what approach would you recommend be taken in the new criteria?

21. If there is anything else that you want the Government to consider in encouraging domestic manufacturing of PV panels and components, please address.

I. Background

CMS, through the Office of Burden Reduction and Health Informatics (OBRHI), seeks to partner with VCU in the development of a collaborative survey tool that will bring together the perspectives of patients, providers, and payors to understand their experiences across the range of health services they receive over time, also known as the healthcare continuum- specifically in mental and behavioral health services. In alignment with HHS' commitment to addressing the nation's behavioral health crises and strengthening mental health of all Americans, CMS anticipates the development and implementation of this survey will represent an opportunity to use new research methods to advance healthcare beyond its current separation of mind, body, and specialty. The right tool can enable all health outcomes—physical, behavioral, emotional, psychological, cultural, and social—by directing attention to those things patients and clinicians find most important about their care.

Summarized below are the high-level key goals/aims of this project.

• Environmental mapping to discover those questions that will yield feedback essential to understanding the patient experience across the healthcare continuum.

• Identification of elements of care most meaningful to stakeholders through crowd-sourcing.

• Facilitated collaborative workgroup(s) and listening sessions.

• Rigorous and multimodal testing of the designed survey.

• National survey distribution in the manner(s) in which CMS designates.

• Post-survey evaluation and reporting of incoming response data.

• Peer-reviewed publication(s) and conference presentations based on survey findings.

• Application for endorsement from the National Quality Forum (NQF) and the Measures Application Partnership (MAP).

CMS is anticipating approximately a total of $3,280,362 will be available to VCU for this cooperative agreement, pending availability of funds. VCU may use grant funds for a variety of planning, development, testing, and implementation objectives related to a collaborative patient-provider-payer survey tool that will assist in facilitating the integration of the patient care behavioral and mental health survey delivery. This includes but is not limited to hiring or contracting with professionals or firms to complete the work.

Pending an acceptable application and budget, CMS recommends awarding a single source cooperative agreement to VCU (as host institution to The Larry A. Green Center). As the developer of the Person-Centered Primary Care Measure (PCPCM), The Larry A. Green Center is uniquely positioned to provide this support to CMS. The PCPCM is a survey-based measure that asks patients to assess their personal experience of care using the pillars of primary care—comprehensiveness, first contact access, coordination, and continuity—as guideposts. While the PCPCM measure will not be utilized for this survey tool, the methodology and partnerships used in the PCPCMs creation are the foundation for the survey tool as evidenced by the following:

• Robust stakeholder engagement that incorporated the expertise of over 1,000 individuals and 40 organizations.

• Combined digital and social theory methods to crowd-source information among stakeholder groups.

• Demonstrated experience in improving accountability while reducing burden and cost for users- using a design process that listened to end users and enabled learning to ask the right questions. The process allowed The Larry A. Green Center to then develop the best solutions to those questions and apply systemic constraints so the best solution can be operational and pragmatic.

To date, there are no other surveys that take into consideration patients, providers, and payors as a whole. As a result of their endorsed PCPCM tool, expertise, capability to facilitate relationships with groups not often known to work together, and proven track record for success, The Larry A. Green Center (through VCU as the host institution and legal applicant) is the only organization suitable to complete the task at hand.

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

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

The system of records covers individually identifiable records about individuals that are retrieved by a personal identifier to conduct OPRE research, evaluation, and data projects that study how to improve the economic and social well-being of children and families and/or increase the effectiveness and efficiency of programs inside and outside ACF working towards that goal (OPRE Projects). While the results of these studies are generally deidentified and made publicly available, the process of collecting and analyzing the information may, in some instances, require retrieving identifiable records about individuals by personal identifier (for example, to combine or de-duplicate data about the same individual collected at different times or from different sources). The majority of OPRE Projects are conducted without directly retrieving records by personal identifier, so do not involve Privacy Act records.

The updated System of Records Notice (SORN) published in this notice includes the following modifications:

• The SORN has been reformatted to comply with current format requirements in OMB Circular A-108, issued December 23, 2016. The Circular changed the order and headings of certain SORN sections and added a “SORN History” section.

• The “System Location” and “System Manager(s)” sections have been updated with current addresses, and the System Manager(s) section now includes an email address.

• The “Authorities” section no longer cites 42 U.S.C. 7103 and 42 U.S.C. 9858 et seq. and the Consolidated Appropriations Act of 2008, and now cites the following in addition to the other previously cited authorities. Some of the newly cited statutes specifically identify when ACF should provide a service or evaluate an activity. The other statutes give ACF the authority to distribute funds; recipients must report information about the individuals assisted via those funds to ACF, which is then used in one or more OPRE Projects.

○ 22 U.S.C. 7104 and 7105 (authorizes the HHS Secretary to provide grants to help victims of human trafficking and educate individuals about human trafficking).

○ 34 U.S.C. 11243 (authorizes the HHS Secretary to carry out research, evaluation, demonstration, and service projects to increase knowledge concerning, and to improve services for, runaway youth and homeless youth);

○ 42 U.S.C. 5105 (authorizes the HHS Secretary to fund a continuous program of research on how to better protect children from child abuse or neglect and improve the well-being of victims of child abuse or neglect);

○ 42 U.S.C. 9844 (authorizes the HHS Secretary, directly or through grants or contracts, to carry out research, demonstrations, and evaluation activities to improve Head Start programs);

○ 42 U.S.C. 10404 (authorizes the HHS Secretary to coordinate Departmental programs to prevent family violence, domestic violence, or dating violence);

○ 42 U.S.C. 1397 et seq. (discusses the administration of the Block Grants to States for Social Services and research connected to those grants);

○ 42 U.S.C. subchapter II-B (authorized Child Care and Development Block Grants in fiscal years (FYs) 2015 through 2020 to fund state child care programs; data funded in prior FYs still exists);

○ 42 U.S.C. subchapter V (authorizes the HHS Secretary to support special projects of regional and national significance and research regarding maternal and child health); and

○ Executive Order (E.O.) 9397 as amended by E.O. 13478 (addresses use of personal identifiers).

• The “Purpose(s)” section has been revised to add a description of types of OPRE Projects, which are listed as a. through g., and to omit an unnecessary statement that the procedures for collecting information about research subjects in OPRE Projects are reviewed, as appropriate, by Institutional Review Boards and are subject to HHS regulations on research with human subjects, including requirements for informed consent.

• The “Categories of Individuals” section has been clarified and expanded. Instead of stating that information is about research “participants” and may include information about family members of program participants and service recipients, it encompasses program clients, individuals (such as family members) who provide information about program clients, and sole practitioners who provide services to program clients; and it makes clear that information about them may be from a pre-existing dataset used in an OPRE Project, not necessarily newly collected specifically for the OPRE Project.

• The “Categories of Records” section includes some revised and additional examples of data elements that may be contained in the records; i.e.:

○ “Email address” has been added to the examples of contact information.

○ In the examples of sociodemographic information, “date of birth” has been changed to “age”; “citizenship” has been removed; and the following have been added: tribal affiliation, gender, sexuality, language preferences and proficiencies, responses to assessments and collections ( e.g., surveys and interviews), photographs, voice and video recordings and transcripts, bio-specimens, correspondences, and administrative records.

○ In examples of other information, “income” has been changed to “finances”; “pre-school Head start participation” has been broadened to “other governmental services”; and the following have been added: education; living situation, sexual history, mental and physical health and well-being, criminal activities, risky behaviors ( e.g., illicit drug use), family dynamics ( e.g., beliefs), and disabilities.

• The “Record Source Categories” section has been reworded but not substantively changed.

• The “Routine Uses” section includes the following updates:

○ The introduction omits this statement: “In addition, contractors may be restricted by contract from making a disclosure allowed as a routine use or by law without the consent of HHS, of the data subject, or both, unless the disclosure is required by law.”

○ Three existing routine uses have been revised, as follows:

Routine use 2, which authorizes disclosures incident to requesting information, has been revised to change “information” to “records” and to change “research or evaluation” to “OPRE Project.”

Routine use 4, which authorizes disclosures to the Department of Justice or in proceedings, has been revised to omit a statement about compatibility with the original collection purpose, which is redundant because it repeats part of the definition of a routine use.

Routine use 5, which previously authorized disclosures to HHS contractors, has been revised to include HHS grantees and to add, as a condition of disclosure, that the contractor or grantee must be required by the terms of the contract or grant to comply with the Privacy Act.

○ One routine use has been deleted (numbered as 6 in the existing SORN); it authorized disclosures to claims examiners, investigators, arbitrators, etc., at other agencies (including the Office of Personnel Management, Office of Special Counsel, Merit System Protection Board, Federal Labor Relations Authority, Equal Opportunity Commission, and Office of Government Ethics) in administrative grievance, claim, complaint, and appeal cases filed by employees. In the unlikely event that an employee's work, with or responsibility for, records in this system of records were to become an issue in such a case, it should not be necessary to use identifiable records from this system of records for investigation, discovery, evidentiary, settlement, or other purposes in the case.

○ Two new routine uses have been added (numbered as 9 and 10) authorizing disclosures for research that will not impact the record subject and disclosures so that an organization that serves an individual under a federal contract may access information about its services to continue serving the individual.

• A section headed “Disclosure to Consumer Reporting Agencies” has been removed as unnecessary, because the section merely confirmed that such disclosures are not made from this system of records.

• The “Storage” section previously stated that, depending on the project, records “may be stored on paper or other hard copy, computers, and networks,” and now states that records “are stored in paper and electronic form.”

• The “Retrieval” section has been reworded but not substantively changed.

• The “Retention” section no longer states that identifiers are removed once the analysis is complete. Instead, it now states that a disposition schedule is pending approval by the National Archives and Records Administration (NARA), which proposes that the records be cutoff upon completion of final report or termination of evaluation and be destroyed 5 years after cutoff; and that ACF/OPRE will continue to retain the records indefinitely until the schedule is approved by NARA.

• The “Safeguards” section, which previously stated that contractors and other record keepers are required to maintain “appropriate” administrative, technical, and physical safeguards and that records are “secured in compliance with Federal requirements” now describes particular administrative, technical, or physical safeguards that are used to protect the records from unauthorized access.

• The “Record Access Procedures,” “Contesting Record Procedures,” and “Notification Procedures” sections have been revised to state that access, amendment, and notification requests “must” (instead of “should”) be in writing and contain identity verification information; to no longer require that requests include “Social Security Number ” (SSN); and to specify how the requester's identity may be verified ( i.e., by a notarized signature or a statement signed under penalty of perjury) instead of stating that verification of identity would be “as described in the Department's Privacy Act regulations.”

Because some of these changes are significant, HHS provided advance notice of the modified system of records to the Office of Management and Budget and Congress as required by 5 U.S.C. 552a(r) and OMB Circular A-108.

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.

ENDEP (amitriptyline hydrochloride) oral concentrate, 40 mg/mL, is the subject of ANDA 085749, held by Hoffman-La Roche Inc., and initially approved on December 23, 1977. ENDEP (amitriptyline hydrochloride) oral concentrate, 40 mg/mL, is indicated for relief of symptoms of depression.

Hoffman-La Roche Inc. has never marketed ENDEP (amitriptyline hydrochloride) oral concentrate, 40 mg/mL. ANDA 085749 is listed in the “Discontinued Drug Product List” section of the Orange Book.

Hyman, Phelps & McNamara, P.C., submitted a citizen petition dated January 11, 2022 (Docket No. FDA-2022-P-0068), under 21 CFR 10.30, requesting that the Agency determine whether ENDEP (amitriptyline hydrochloride) oral concentrate, 40 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 ENDEP (amitriptyline hydrochloride) oral concentrate, 40 mg/mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that ENDEP (amitriptyline hydrochloride) oral concentrate, 40 mg/mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of ENDEP (amitriptyline hydrochloride) oral concentrate, 40 mg/mL, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that this drug product was not withdrawn from sale for reasons of safety or effectiveness.

Accordingly, the Agency will continue to list ENDEP (amitriptyline hydrochloride) oral concentrate, 40 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. ANDAs that refer to ENDEP (amitriptyline hydrochloride) oral concentrate, 40 mg/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.

I. Background and Purpose

The CTTI is a public-private partnership cofounded by FDA and Duke University whose mission is to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. FDA and CTTI have long involved patients and considered patient perspectives in their work. Furthering the engagement of diverse patients as valued partners across the medical product research and development continuum requires an open forum for patients and regulators to discuss and exchange ideas.

The PEC is an ongoing, collaborative forum in which the patient community and regulators discuss an array of topics regarding increasing patient engagement in medical product development and regulatory discussions at FDA. The PEC is a joint endeavor between FDA and CTTI. The activities of the PEC may inform relevant FDA and CTTI activities. The PEC is not intended to advise or otherwise direct the activities of either organization, and membership will not constitute employment by either organization.

The Food and Drug Administration Safety and Innovation Act (Pub. L. 112-14), section 1137, entitled “Patient Participation in Medical Product Discussions,” added section 569C to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-8c). This provision directs the Secretary of Health and Human Services to “develop and implement strategies to solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory discussions.” On November 4, 2014, FDA issued a Federal Register notice establishing a docket (FDA-2014-N-1698) for public commenters to submit information related to FDA's implementation of this provision. Upon review of the comments received, one common theme, among others, included establishing an external group to provide input on patient engagement strategies across FDA's Centers. After considering the comments, FDA formed the PEC in 2018 to discuss a variety of patient engagement topics. This group is consistent with additional legislation subsequently enacted in section 3001 of the 21st Century Cures Act (Pub. L. 114-255) and section 605 of the FDA Reauthorization Act of 2017 (Pub. L. 115-52), further supporting tools for fostering patient participation in the regulatory process.

The PEC currently has 16 members. To help ensure continuity in its activities and organizational knowledge, the PEC maintains staggered membership terms. As of fall 2022, eight members will complete a term and up to eight new members will be selected. The purpose of this notice is to announce that the application process for up to eight new members of the PEC is now open, and to invite and encourage applications by the submission deadline for appropriately qualified individuals.

The PEC includes up to 16 diverse representatives of the patient community. Eight members from the previous application process will remain on the PEC. The current application process is to select up to eight new PEC members. Selected members will include the following: (1) patients who have personal disease experience; (2) caregivers who support patients, such as a parent, child, partner, other family member, or friend, and who have personal disease experience through this caregiver role; and/or (3) representatives of patient groups who, through their role in the patient group, have direct or indirect disease experience. Please note that for purposes of this activity, the term “caregiver” is not intended to include individuals who are engaged in caregiving as healthcare professionals; and the term “patient group” is used herein to encompass patient advocacy organizations, disease advocacy organizations, voluntary health agencies, nonprofit research foundations, and public health organizations. The ultimate goal of the application and selection process is to identify individuals who can represent a collective patient voice for their patient community.

Selection criteria include the applicant's potential to meaningfully contribute to the activities of the PEC, ability to represent and express the patient voice for their constituency, ability to work in a constructive manner with involved stakeholders, and understanding of the clinical research enterprise. Consideration will also be given to ensuring the PEC includes diverse perspectives and experiences, including but not limited to sociodemographic factors (such as age, gender, ethnicity, education level, income) and disease experience. PEC members are required to be residents of the United States and must be 18 years of age or older.

Financial and other conflicts of interest will not necessarily make applicants ineligible for membership in the PEC. However, applicants cannot be direct employees of the medical product development industry or a currently registered lobbyist for an FDA-regulated industry.

Participation as a PEC member is voluntary. Working meetings of the PEC will typically be held two to four times per year, either in person (in the Washington, DC area) or virtually (teleconference or webinar). Given the ongoing COVID-19 pandemic, meetings will be conducted virtually and may resume in-person when it is safe to do so. Additional meetings may be organized as needed, and currently include monthly, 1-hour teleconferences.

Reasonable accommodations will be made for members with special needs for travel or for participation in a meeting. Applications for PEC membership are encouraged from individuals of all ages, sexes, genders, sexual orientations, racial and ethnic groups, education levels, income levels, and those with and without disabilities. Travel support will be provided as applicable.

To help ensure continuity in its activities and organizational knowledge, the PEC will maintain staggered membership terms for patient community representatives. Membership terms for new members will be 2-year appointments. Members may serve up to two terms, with the possibility of extensions.

Additional responsibilities and expectations are set forth in the PEC Framework, which should be reviewed prior to submitting an application, and is available at https://ctti-clinicaltrials.org/wp-content/uploads/2021/07/patient_engagement_collaborative_framework_-_revised_25jan2021.pdf.

Any interested person may apply for membership on the PEC. To apply, go to https://duke.qualtrics.com/jfe/form/SV_5nI1VVWVOaD59ky. The application is completed online and includes questions to help determine eligibility for the PEC, demographic and other background questions, and four brief essay questions. Many of the demographic questions are optional. The brief essay questions, to be answered in 500 characters or fewer (including spaces), are as follows:

• Please explain why you would have an outstanding ability to represent and express the patient voice for the disease area(s) you selected above.

• Please give a few examples of experiences that demonstrate your outstanding ability to work across or interact with stakeholders in the medical product development and regulatory processes.

• Please explain how you have established an understanding of the medical product development and regulatory processes.

• Please tell us why you are interested in becoming a member of the PEC and how you would be able to contribute.

Completing the application also involves submitting: (1) A current one-page résumé or bio that summarizes your patient advocacy experience and related activities (PDF format required) and (2) A one-page letter of endorsement from a patient group with which the applicant has worked closely on activities that are relevant to the PEC (PDF format required). Please note, only the application and the two documents specified above will be reviewed. Your completed application form, résumé or bio, and letter of endorsement should all be submitted at the same time.

The résumé or bio must provide examples and descriptions of relevant activities and experiences related to the applicant's qualifications for PEC membership. The letter of endorsement should emphasize information relevant to the criteria for membership described above. This letter must be from and written by someone other than yourself. The letter may address topics such as the applicant's involvement in patient advocacy activities, experiences that stimulated an interest in participating in discussions about patient engagement in medical product development and regulatory decision processes, and other information that may be helpful in evaluating the applicant's qualifications as a potential member of the PEC.

Applications will be accepted until 11:59 p.m. eastern time on October 19, 2022 or until 75 applications are received, whichever happens first. Only complete applications will be considered.

The application review period will take a minimum of 2 months after 11:59 p.m. eastern time on October 19, 2022.

Additional information may be needed from some applicants during the review period, including information relevant to understanding potential sources of conflict of interest, in which case applicants will be contacted directly. All applicants (both those selected for PEC membership and those who are not selected) will be notified of the final application decision no later than the end of the 2022 calendar year.

Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will discuss new drug application 213931, for tenapanor hydrochloride tablets, submitted by Ardelyx, Inc., for the control of serum phosphorus levels in adults with chronic kidney disease on dialysis. The committee will be asked to comment on whether the size of the treatment effect on serum phosphorus is clinically meaningful and whether tenapanor's benefits outweigh its risks.

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 submitted to the Docket (see ADDRESSES ) on or before November 1, 2022, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 2:30 p.m. and 3:30 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 October 24, 2022. 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 October 25, 2022.

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 LaToya Bonner (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).

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

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

This information collection supports FDA regulations and guidance. Tobacco products are generally governed by chapter IX of the Federal Food, Drug, and Cosmetic Act (sections 900 through 920) (21 U.S.C. 387 through 21 U.S.C. 387t).

On March 18, 2020, FDA issued a final rule establishing new cigarette health warnings for cigarette packages and advertisements entitled “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements” (85 FR 15638; https://www.federalregister.gov/d/2020-05223 ). The final rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning label statements. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act of 1965 (FCLAA) (15 U.S.C. 1333) to require each cigarette package and advertisement to bear one of the new required warnings. The final rule specifies the 11 new textual warning label statements and accompanying color graphics.

Section 1141.10(g) (21 CFR 1141.10(g) and section 4(c) of the FCLAA sets forth the specific marketing requirements relating to the random and equal display and distribution of required warnings on cigarette packaging and quarterly rotation of required warnings in alternating sequence in cigarette advertising and requires the submission of plans outlining how the cigarette packaging and advertising will comply with such requirements. FDA must review and approve cigarette plans in advance of any person displaying or distributing cigarette packages or advertisements for products that are required to carry the required warnings, and a record of the FDA-approved plan must be established and maintained by the tobacco product manufacturer.

To implement these statutory and regulatory requirements, cigarette plans will be reviewed by FDA upon submission by respondents. FDA published a guidance document on July 9, 2021, entitled “Submission of Plans for Cigarette Packages and Cigarette Advertisements” which describes cigarette plans information, format and submission ( https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-plans-cigarette-packages-and-cigarette-advertisements-revised ).

Pursuant to section 201(b) of the Tobacco Control Act, FDA finalized the “Required Warnings for Cigarette Packages and Advertisements” rule with an effective date of June 18, 2021, 15 months after the date of publication. On April 3, 2020, the final rule was challenged in the U.S. District Court for the Eastern District of Texas. 1 The effective date of the final rule has been delayed in accordance with orders issued by the U.S. District Court for the Eastern District of Texas. Visit FDA's website at https://www.fda.gov/tobacco-products/labeling-and-warning-statements-tobacco-products/cigarette-labeling-and-health-warning-requirements for updates regarding the effective date of the rule and related timelines, including the recommended date for submitting cigarette plans for FDA review.

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

The burden estimates are based on FDA's experience with information collections for other tobacco product plans ( i.e., smokeless, OMB control number 0910-0671 and cigars, OMB control number 0910-0768) and 2017 Treasury Alcohol and Tobacco Tax and Trade Bureau data.

FDA estimates 59 entities are affected. We estimate these 59 entities will submit initial plans, and it will take an average of 150 hours per respondent to prepare and submit a plan for packaging and advertising for a total of 8,850 hours. We estimate that about half of respondents will submit a supplement. If a supplement to an approved plan is submitted, FDA estimates it will take half the time per response. We estimate receiving 30 supplements at 75 hours per response for a total of 2,250 hours. FDA estimates that the total hours for submitting initial plans and supplements will be 11,100.

Section 1141.10(g)(4) establishes that each tobacco product manufacturer required to randomly and equally display and distribute warnings on cigarette packages or quarterly rotate warnings in cigarette advertisements in accordance with an FDA-approved plan under section 4 of the FCLAA and part 1141 must maintain a copy of the FDA-approved plan (approved under § 1141.10(g)(3)). This copy of such FDA-approved plan must be available for inspection and copying by officers or employees of FDA. This subsection requires that the FDA-approved plan must be retained while in effect and for a period of not less than 4 years from the date it was last in effect.

Meeting Accessibility: The Hypertension Summit will be held virtually.

All attendees must register to receive the virtual conference information for the Hypertension Summit.

For more information on how to register to attend, please visit https://www.zoomgov.com/webinar/register/WN_Z33WazyITyaeP29xVmyIKw.

Background: The HHS Office on Women's Health (OWH) is charged with providing expert advice and consultation to the Secretary concerning scientific, legal, ethical, and policy issues related to women's health. OWH establishes short-range and long-range goals within the Department and coordinates on activities within the Department that relate to disease prevention, health promotion, service delivery, research, and public and health care professional education, for issues of particular concern to women throughout their lifespan. OWH monitors the Department's activities regarding women's health and identifies needs regarding the coordination of activities. OWH is also responsible for facilitating the exchange of information through the National Women's Health Information Center. Additionally, OWH coordinates efforts to promote women's health programs and policies with the private sector. National Women's Blood Pressure Awareness Week (NWBPAW) is an observance that focuses on evidence to address practice gaps and to improve women's health outcomes related to hypertension.

The Hypertension Summit will occur during NWBPAW and will emphasize the importance of blood pressure control. The Hypertension Summit will facilitate the exchange information and seek input on an individual basis from: patients, who have benefited from innovative approaches to treating hypertension; subject matter experts; Phase 1 awardees of the HHS Hypertension Innovator Award Competition; and members of OWH's Self-Measured Blood Pressure Program (SMBP).

Topics covered during the Hypertension Summit: The agenda will be made up of several panels and presentations focusing on the innovations and evidence to bridge practice gaps in the field of hypertension treatment and prevention. Topics may include, but are not limited to, innovations and evidence to bridge practice gaps in the field of hypertension, self-measured blood pressure, telehealth, technology, health equity, hypertension in pregnancy and/or postpartum, home-based care, and health team integration.

The Hypertension Summit is open to the public. Information regarding the start and end times and any updates to agenda topics will be available at https://www.womenshealth.gov/hypertensionsummit closer to the date of the Hypertension Summit.

Procedures for Attendance: https://www.zoomgov.com/webinar/register/WN_Z33WazyITyaeP29xVmyIKw.

On March 27, 2020, FEMA published a proposed notice at 85 FR 17338, proposing flood hazard determinations for Winneshiek County, Iowa and Incorporated Areas. FEMA is withdrawing the proposed notice.

Authority: 42 U.S.C. 4104; 44 CFR 67.4.

Pursuant to Executive Order 12148, as amended by Executive Order 12673 and Executive Order 13286, the President of the United States has delegated to the Department of Homeland Security (DHS), including FEMA, the authority to provide case management services as stated in the Robert T. Stafford Disaster Relief and Emergency Assistance Act (Stafford Act), 42 U.S.C. 5189d. Under the Stafford Act, FEMA may provide DCM services directly to survivors through financial assistance to State, Indian tribal, or territorial government agencies. DCM services include identifying and addressing disaster-caused unmet needs of survivors through identification of, and referrals to, available resources. A disaster-caused unmet need is an un-resourced item, support, or assistance that has been assessed and verified as necessary for a survivor to recover from a disaster. This may include food, clothing, shelter, first aid, emotional and spiritual care, household items, home repair, or rebuilding.

When a State, Tribe, or territory (STT) applies for, requests a modification of, or appeals a FEMA determination for DCM Federal funding, the STT will utilize the respective forms to illustrate the need, why it is beyond the STT capacity to provide case management services itself, and how the STT will provide services to all populations in need. Additionally, the STT will be required to use the OMB-approved Standard Form 424 form family when applying for Federal funding.

To supplement their request, the STT will also submit a funding request using the budget form. The information gathered within these forms in the collection tool is used to determine the STT's need for DCM Federal funding and how they anticipate providing services to survivors.

Once awarded, the STT will use the monthly reporting collection tool to provide aggregate data on the services provided to survivors. The information gathered within this form helps FEMA assess the success of the program and ensure that all survivors in need of services are able to receive them and that the case managers are assisting survivors in finding resources that meet their disaster-caused unmet needs.

Title: State, Tribe, and Territory Disaster Case Management Federal Award.

Type of Information Collection: New information collection.

OMB Number: 1660-NW153.

FEMA Forms: DCM Federal Award Application, FF-104-FY-22-204; DCM Federal Award Modification Request, FF-104-FY-22-206; DCM Federal Award Request for Appeal, FF-104-FY-22-207; DCM Federal Award Monthly Reporting, FF-104-FY-22-208; and DCM Federal Award Budget Workbook, FF-104-FY-22-209.

Abstract: This collection tool will primarily be used as a guide to support state, tribal, and territorial governments (STTs) when applying, requesting a modification, or appealing a FEMA determination for Disaster Case Management Federal funding to supplement and expand their existing capacity. In extraordinary circumstances, the STT may request that FEMA provide an opportunity for a local government agency or qualified private organization to apply for the DCM Federal Award directly. Once awarded, the STT will utilize the monthly reporting form to report aggregate data about the performance of their program. All information collected within these forms will be submitted to FEMA by the STT.

When applying for the STT DCM Federal award, the STT will respond to the questions within the application form, developing an overall assessment that details activities that have occurred since the start of the disaster; what resources and capabilities are currently available or anticipated to be available; and what the estimated population to serve is. The STT will also outline the implementation of their program by detailing their service delivery and work plans.

If the STT is awarded an STT DCM Federal award, the STT may need to modify their initial award. In doing so, the STT will utilize the Request for Modification collection instrument to answer questions that will assist them in justifying the need to request additional time or funding to further support the implementation of their program.

If the STT chooses to appeal a determination made by FEMA, the STT will outline the purpose for their submission and provide new, justifying information that was not included in their initial or modification request by using the Request to Appeal collection instrument.

For each of the three forms mentioned above, the STT may also need to request initial or supplemental funding by using the Budget Workbook. This collection instrument enables the STT to outline line items that are necessary to implement the program, including personnel, travel, supplies, and contractual items among others. The STT can use this workbook to detail the request at all levels in program implementation so that it can calculate the total amount of funding needed.

Once awarded, the STT will report aggregate data on all aspects of program implementation, including staffing, caseloads, survivor/client needs, and the types of referrals being made, as well as challenges faced during the month and best practices/lessons learned. This information assists FEMA in confirming the effectiveness of the program, providing technical assistance to ensure all survivors are able to receive DCM services, and to continuously evolve programmatic implementation through the collection of best practices/lessons learned. For the purpose of this publication, “State” in the Affected Public below includes the fifty States, all Territories, and the District of Columbia.

Affected Public: State, Local and Tribal Governments.

Estimated Number of Respondents: 55.

Estimated Number of Responses: 209.

Estimated Total Annual Burden Hours: 577.

Estimated Total Annual Respondent Cost: $43,962.

Estimated Respondents' Operation and Maintenance Costs: $0.

Estimated Respondents' Capital and Start-Up Costs: $0.

Estimated Total Annual Cost to the Federal Government: $127,827.

Comments may be submitted as indicated in the ADDRESSES caption above. Comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper performance of the agency, including whether the information shall have practical utility; (b) 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; (c) enhance the quality, utility, and clarity of the information to be collected; and (d) 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.

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

Title of Information Collection: Applications for Housing Assistance Payments; Special Claims Processing.

OMB Approval Number: 2502-0182.

OMB Expiration Date: January 31, 2020.

Type of Request: Reinstatement, with change, of previously approved collection for which approval has expired.

Form Number: HUD 52670-A part 5, HUD-52671-C, HUD 52671-A, HUD-52671-D, 52670-A-PART-1, HUD 52671-B, HUD-52670, HUD 52670-A-part 3, HUD-52670-A part 4, HUD 52670-A Part 2.

Description of the need for the information and proposed use: The Department needs to collect this information in order to establish an applicant's eligibility for admittance to subsidized housing, specify which eligible applicants may be given priority over others, and prohibit racial discrimination in conjunction with selection of tenants and unit assignments. The Department must specify tenant eligibility requirements as well as how tenants' incomes, rents and assistance must be verified and computed so as to prevent the Department from making improper payments to owners on behalf of assisted tenants. The Department also must provide annual reports to Congress and the public on the race/ethnicity and gender composition of subsidy program beneficiaries. This information is essential to maintain a standard of fair practices in assigning tenants to HUD Multifamily properties.

HUD must specify tenant eligibility requirements as well as how tenants' incomes, rents and assistance must be verified and computed so as to prevent HUD from making improper payments to owners on behalf of assisted tenants. These information collections are essential to ensure the reduction of improper payments standard in providing $13 billion in rental assistance to low-income families in HUD Multifamily properties.

Respondents: Individuals or households, Business or other for-profit, Not-for-profit institutions, Federal Government and State, Local or Tribal Government.

Estimated Number of Respondents: 27,938.

Estimated Number of Responses: 334,958.

Frequency of Response: 1.

Average Hours per Response: 4.25.

Total Estimated Burden: 581,486.

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

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

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

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

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

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

The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Daedalus Prime LLC on September 13, 2022. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of regarding certain semiconductor devices, mobile devices containing the same, and components thereof. The complainant names as respondents: Samsung Electronics Co., Ltd. of Korea; Samsung Electronics America, Inc. of Ridgefield Park, NJ; Taiwan Semiconductor Manufacturing Company Limited of Taiwan and TSMC North America of San Jose, CA. The complainant requests that the Commission issue a limited exclusion order and cease and desist orders and impose a bond upon respondent's alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).

Proposed respondents, other interested parties, and members of the public are invited to file comments on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.

In particular, the Commission is interested in comments that:

(i) explain how the articles potentially subject to the requested remedial orders are used in the United States;

(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;

(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;

(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and

(v) explain how the requested remedial orders would impact United States consumers.

Written submissions on the public interest must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the Federal Register . There will be further opportunities for comment on the public interest after the issuance of any final initial determination in this investigation. Any written submissions on other issues must also be filed by no later than the close of business, eight calendar days after publication of this notice in the Federal Register . Complainant may file replies to any written submissions no later than three calendar days after the date on which any initial submissions were due. No other submissions will be accepted, unless requested by the Commission. Any submissions and replies filed in response to this Notice are limited to five (5) pages in length, inclusive of attachments.

Persons filing written submissions must file the original document electronically on or before the deadlines stated above. Submissions should refer to the docket number (“Docket No. 3641”) in a prominent place on the cover page and/or the first page. ( See Handbook for Electronic Filing Procedures, Electronic Filing Procedures  1 ). Please note the Secretary's Office will accept only electronic filings during this time. Filings must be made through the Commission's Electronic Document Information System (EDIS, https://edis.usitc.gov. ) No in-person paper-based filings or paper copies of any electronic filings will be accepted until further notice. Persons with questions regarding filing should contact the Secretary at EDIS3Help@usitc.gov.

Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this Investigation may be disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, 2 solely for cybersecurity purposes. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS. 3

This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).

The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Daedalus Prime LLC on September 13, 2022. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of regarding certain integrated circuits, mobile devices containing the same, and components thereof. The complainant names as respondents: Samsung Electronics Co., Ltd. of Korea; Samsung Electronics America, Inc. of Ridgefield Park, NJ; and Qualcomm Inc. of San Diego, CA. The complainant requests that the Commission issue a limited exclusion order and cease and desist orders and impose a bond upon respondent's alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).

Proposed respondents, other interested parties, and members of the public are invited to file comments on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.

In particular, the Commission is interested in comments that:

(i) explain how the articles potentially subject to the requested remedial orders are used in the United States;

(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;

(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;

(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and

(v) explain how the requested remedial orders would impact United States consumers.

Written submissions on the public interest must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the Federal Register . There will be further opportunities for comment on the public interest after the issuance of any final initial determination in this investigation. Any written submissions on other issues must also be filed by no later than the close of business, eight calendar days after publication of this notice in the Federal Register . Complainant may file replies to any written submissions no later than three calendar days after the date on which any initial submissions were due. No other submissions will be accepted, unless requested by the Commission. Any submissions and replies filed in response to this Notice are limited to five (5) pages in length, inclusive of attachments.

Persons filing written submissions must file the original document electronically on or before the deadlines stated above. Submissions should refer to the docket number (“Docket No. 3640”) in a prominent place on the cover page and/or the first page. (See Handbook for Electronic Filing Procedures, Electronic Filing Procedures  1 ). Please note the Secretary's Office will accept only electronic filings during this time. Filings must be made through the Commission's Electronic Document Information System (EDIS, https://edis.usitc.gov. ) No in-person paper-based filings or paper copies of any electronic filings will be accepted until further notice. Persons with questions regarding filing should contact the Secretary at EDIS3Help@usitc.gov.

Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this Investigation may be disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, 2 solely for cybersecurity purposes. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS. 3

This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).

The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Vego Garden, Inc. on September 13, 2022. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of regarding certain raised garden beds and components thereof. The complainant names as respondents: Huizhou Green Giant Technology Co., Ltd. of China; Utopban International Trading Co., Ltd., d/b/a Vegega of Rosemead, CA; Kinghood International Logistics Inc. of Corona, CA; Utopban Limited of Hong Kong; The Hydro Source Inc., d/b/a Forever Garden Beds of El Monte, CA; VegHerb, LLC, d/b/a Frame It All of Cary, NC; and Quanzhou Jieliya Trading Co., Ltd. of China. The complainant requests that the Commission issue a limited exclusion order and cease and desist orders and impose a bond upon respondent's alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).

Proposed respondents, other interested parties, and members of the public are invited to file comments on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.

In particular, the Commission is interested in comments that:

(i) explain how the articles potentially subject to the requested remedial orders are used in the United States;

(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;

(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;

(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and

(v) explain how the requested remedial orders would impact United States consumers.

Written submissions on the public interest must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the Federal Register . There will be further opportunities for comment on the public interest after the issuance of any final initial determination in this investigation. Any written submissions on other issues must also be filed by no later than the close of business, eight calendar days after publication of this notice in the Federal Register . Complainant may file replies to any written submissions no later than three calendar days after the date on which any initial submissions were due. No other submissions will be accepted, unless requested by the Commission. Any submissions and replies filed in response to this Notice are limited to five (5) pages in length, inclusive of attachments.

Persons filing written submissions must file the original document electronically on or before the deadlines stated above. Submissions should refer to the docket number (“Docket No. 3639”) in a prominent place on the cover page and/or the first page. ( See Handbook for Electronic Filing Procedures, Electronic Filing Procedures  1 ). Please note the Secretary's Office will accept only electronic filings during this time. Filings must be made through the Commission's Electronic Document Information System (EDIS, https://edis.usitc.gov. ) No in-person paper-based filings or paper copies of any electronic filings will be accepted until further notice. Persons with questions regarding filing should contact the Secretary at EDIS3Help@usitc.gov.

Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this Investigation may be disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, 2 solely for cybersecurity purposes. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS. 3

This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Bureau of Justice Statistics, including whether the information will have practical utility;

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;

Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and

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.

Type of Information Collection: Extension of a Currently Approved Collection.

The Title of the Form/Collection: National Prisoner Statistics program. The collection includes the following parts: Summary of Sentenced Population Movement, Prison Population Report—U.S. Territories.

The agency form number, if any, and the applicable component of the Department sponsoring the collection: Form numbers for the questionnaire are NPS-1B (Summary of Sentenced Population Movement) and NPS-1B(T) (Prisoner Population Report—U.S. Territories). The applicable component within the Department of Justice is the Bureau of Justice Statistics, in the Office of Justice Programs.

Affected public who will be asked or required to respond, as well as a brief abstract: For the NPS-1B form, 51 central reporters (one from each state and the Federal Bureau of Prisons) responsible for keeping records on inmates will be asked to provide information for the following categories:

(a) As of December 31, the number of male and female inmates within their custody and under their jurisdiction with maximum sentences of more than one year, one year or less; and unsentenced inmates;

(b) The number of inmates housed in privately operated facilities, county or other local authority correctional facilities, or in other state or Federal facilities on December 31;

(c) Prison admission information in the calendar year for the following categories: new court commitments, parole violators, other conditional release violators returned, transfers from other jurisdictions, AWOLs and escapees returned, and returns from appeal and bond;

(d) Prison release information in the calendar year for the following categories: expirations of sentence, commutations, other conditional releases, probations, supervised mandatory releases, paroles, other conditional releases, deaths by cause, AWOLs, escapes, transfers to other jurisdictions, and releases to appeal or bond;

(e) Number of inmates under jurisdiction on December 31 by race and Hispanic origin;

(f) Number of inmates under physical custody on December 31 classified as non-citizens; U.S. citizens; and unsentenced inmates;

(g) Number of inmates under physical custody on December 31 who are citizens of the U.S. with maximum sentences of more than one year, one year or less; and unsentenced inmates;

(h) The source of U.S. citizenship data;

(i) Testing of incoming inmates for HIV; and HIV infection and AIDS cases on December 31; and

(j) The aggregated rated, operational, and/or design capacities, by sex, of the state/BOP's correctional facilities at year-end.

For the NPS-1B(T) form, five central reporters from the U.S. Territories and Commonwealths of Guam, Puerto Rico, the Northern Mariana Islands, the Virgin Islands, and American Samoa will be asked to provide information for the following categories for the calendar year just ended, and, if available, for the previous calendar year:

(a) As of December 31, the number of male and female inmates within their custody and under their jurisdiction with maximum sentences of more than one year, one year or less; and unsentenced inmates; and an assessment of the completeness of these counts (complete, partial, or estimated)

(b) The number of inmates under jurisdiction on December 31 but in the custody of facilities operated by other jurisdictions' authorities solely to reduce prison overcrowding;

(c) Number of inmates under jurisdiction on December 31 by race and Hispanic origin;

(d) The aggregated rated, operational, and/or design capacities, by sex, of the territory's/Commonwealth's correctional facilities at year-end.

The Bureau of Justice Statistics uses this information in published reports and for the U.S. Congress, Executive Office of the President, practitioners, researchers, students, the media, and others interested in criminal justice statistics.

An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: Data collection conducted in 2023, 2024, and 2025 (collecting prison data from 2022, 2023, and 2024, respectively) will require each of the 51 respondents to spend an average of 6.5 total hours to respond to the NPS-1B form. 5 respondents, each taking an average of 2 hours to respond to the NPS-1B(T) form. The burden estimates are based on feedback from respondents, and the burden remains the same as the previous clearance.

An estimate of the total public burden (in hours) associated with the collection: There is an estimated 1,025 total burden hours associated with this collection for the three years of data collection, or approximately 341.5 hours for each year.

If additional information is required contact: Robert Houser, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, United States Department of Justice, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530.

Section 103(h) of the Federal Mine Safety and Health Act of 1977 (Mine Act), 30 U.S.C. 813(h), authorizes MSHA to collect information necessary to carry out its duty in protecting the safety and health of miners. Chronic exposure to respirable coal mine dust causes lung diseases including coal workers' pneumoconiosis (CWP), emphysema, silicosis, and chronic bronchitis, known collectively as “black lung.” MSHA's standards in 30 CFR parts 70, 71, and 90 require each mine operator of an underground coal mine, surface coal mine, and surface work areas of an underground coal mine, and each coal mine operator who employs a part 90 miner, to protect miners from exposure to excessive respirable coal mine dust levels. Parts 70 and 71 require coal mine operators to continuously maintain the average concentration of respirable coal mine dust in the mine atmosphere where miners normally work or travel at or below 1.5 milligrams per cubic meter (mg/m 3 ). For additional substantive information about this ICR, see the related notice published in the Federal Register on May 23, 2022 (87 FR 31261).

This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number. See 5 CFR 1320.5(a) and 1320.6.

DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.

Agency: DOL-MSHA.

Title of Collection: Respirable Coal Mine Dust Sampling.

OMB Control Number: 1219-0011.

Affected Public: Businesses or other for-profits institutions.

Total Estimated Number of Respondents: 676.

Total Estimated Number of Responses: 995,102.

Total Estimated Annual Time Burden: 58,259 hours.

Total Estimated Annual Other Costs Burden: $29,835.

The DOL, as part of continuing efforts to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and federal agencies an opportunity to comment on proposed and/or continuing collections of information before submitting them to the OMB for final approval. This program helps to ensure requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements can be properly assessed.

Background: The Office of Workers' Compensation Programs (OWCP) administers the Federal Employees' Compensation Act (FECA). The Office of Workers' Compensation Programs (OWCP) administers the Federal Employees' Compensation Act (FECA) under statutes 5 U.S.C. 8101 et seq. Congress gave the Secretary of Labor authority to prescribe rules and regulations necessary for the administration and enforcement of the FECA. 5 U.S.C. 8149. The FECA requires the United States to provide compensation to individuals who sustain an injury while in the course of federal employment. 5 U.S.C. 8102. Part of the compensation Congress provided for federal employees is for scheduled impairments. 5 U.S.C. 8107. The Secretary is proposing a new schedule award filing process (with the implementation of a new form, CA-9, Claim for Schedule Impairment) to more efficiently collect the information necessary to support a claim for a scheduled impairment when an injured employee has sustained permanent impairment to a member or function of the body pursuant to the FECA under Section 8107.

Information collected on Form CA-9 provides OWCP with the statutory requirements for permanent impairment claims and must be used to claim compensation for impairment to a body part covered under the schedule established by 5 U.S.C. 8107. In the vast majority of cases whereby permanent impairment is claimed, a claimant continues to be employed by the federal government. In those cases, the Form CA-9 is completed by a federal employee and their supervisor, therefore not affecting the public, as contemplated under the PRA. See 5 CFR 1320.3(c)(3). The Form CA-9 is required of a member of the public on rare occasions, such as when compensation is claimed after the claimant's federal employment has been terminated. It is estimated that no more than 775 of these forms are required of members of the public through the course of a year. Therefore, this request for clearance by OMB only pertains to a small percentage of the overall use of this particular form.

This information collection is subject to the PRA. A federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB under the PRA approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6.

Interested parties are encouraged to provide comments to the contact shown in the ADDRESSES section. Written comments will receive consideration and be summarized and included in the request for OMB approval of the final ICR. In order to help ensure appropriate consideration, comments should mention OMB Number 1240-0NEW. Submitted comments will also be a matter of public record for this ICR and posted on the internet, without redaction. The DOL encourages commenters not to include personally identifiable information, confidential business data, or other sensitive statements/information in any comments.

The DOL is particularly interested in comments that:

• 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;

• 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;

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

• 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.

Agency: DOL-Office of Workers' Compensation Programs.

Type of Review: New information collection.

Title of Collection: Claim for Schedule Award.

Form: CA-9.

OMB Control Number: 1240-0NEW.

Affected Public: Individuals or households.

Estimated Number of Respondents: 775.

Frequency: On occasion.

Total Estimated Annual Responses: 775.

Estimated Average Time per Response: 0.5 hours.

Estimated Total Annual Burden Hours: 388 hours.

Total Estimated Annual Other Cost Burden: 0.00.

Authority: 44 U.S.C. 3506(c)(2)(A).

The text of the order is attached.

LaCrosse Solutions, LLC is the holder of the U.S. Nuclear Regulatory Commission (NRC, the Commission) Possession Only License No. DPR-45, with respect to the possession, maintenance, and decommissioning of the La Crosse Boiling Water Reactor (LACBWR). Operation of the LACBWR is no longer authorized under this license. The LACBWR facility is located in Vernon County, Wisconsin.

By Order dated September 24, 2019 (Transfer Order), the Commission consented to the transfer of the LACBWR license to Dairyland Power Cooperative and approved a conforming license amendment in accordance with Title 10 of the Code of Federal Regulations (10 CFR) 50.80, “Transfer of licenses,” and 10 CFR 50.90, “Application for amendment of license, construction permit, or early site permit.” By its terms, the Transfer Order becomes null and void if the license transfer is not completed within 1 year unless, upon application and for good cause shown, the Commission extends the Transfer Order's September 24, 2020, expiration date. By letter dated June 24, 2020, LaCrosse Solutions, LLC submitted a request to extend the effectiveness of the Transfer Order by 6 months. By Order dated September 1, 2020 (First Extension Order), the Commission extended the Transfer Order's expiration date to March 24, 2021. By letter dated February 2, 2021, LaCrosse Solutions, LLC submitted a request to extend the effectiveness of the Transfer Order by an additional 6 months. By Order dated March 9, 2021 (Second Extension Order), the Commission extended the Transfer Order's expiration date to September 24, 2021. Subsequently, by letter dated August 17, 2021, LaCrosse Solutions, LLC submitted a request to extend the effectiveness of the Transfer Order by an additional 12 months. By Order dated August 30, 2021 (Third Extension Order), the Commission extended the Transfer Order's expiration date to September 24, 2022.

By letter dated August 16, 2022, LaCrosse Solutions, LLC submitted a request to extend the effectiveness of the Transfer Order by an additional 3 months, until December 24, 2022. As stated in the letter, the extension would allow LaCrosse Solutions, LLC sufficient time to complete decommissioning activities. LaCrosse Solutions, LLC further stated that responses to NRC staff requests for additional information (RAIs) regarding the LACBWR Final Status Survey Final Reports (FSSRs) and their associated Release Records are currently under final review by the NRC staff. The letter noted that, based on the current status of the NRC review, it is anticipated that additional time will be needed to finalize the safety evaluation report and approve revised FSSRs.

Based on the above, the NRC has determined that LaCrosse Solutions, LLC has shown good cause for extending the effectiveness of the Transfer Order by an additional 3 months, as requested.

Accordingly, pursuant to Sections 161b, 161i, and 184 of the Atomic Energy Act of 1954, as amended; Title 42 of the United States Code Sections 2201(b), 2201(i), and 2234; and the Commission's regulations at 10 CFR 50.80, it is hereby ordered that the expiration date of the Transfer Order, as extended by the First, Second, and Third Extension Orders, is further extended until December 24, 2022. If the subject license transfer from LaCrosse Solutions, LLC to Dairyland Power Cooperative is not completed by December 24, 2022, the Transfer Order shall become null and void; provided, however, that upon written application and for good cause shown, such date may be extended by order.

This Order is effective upon issuance.

Table of Contents I. Introduction II. Docketed Proceeding(s) I. Introduction

The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.

Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.

The public portions of the Postal Service's request(s) can be accessed via the Commission's website ( http://www.prc.gov ). Non-public portions of the Postal Service's request(s), if any, can be accessed through compliance with the requirements of 39 CFR 3011.301. 1

The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3030, and 39 CFR part 3040, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3040, subpart B. Comment deadline(s) for each request appear in section II.

1. Docket No(s).: CP2021-68; Filing Title: USPS Notice of Amendment to Priority Mail Express, Priority Mail, First-Class Package Service & Parcel Select Contract 8, Filed Under Seal; Filing Acceptance Date: September 13, 2022; Filing Authority: 39 CFR 3035.105; Public Representative: Kenneth R. Moeller; Comments Due: September 21, 2022.

2. Docket No(s).: MC2022-105 and CP2022-109; Filing Title: USPS Request to Add Priority Mail Contract 761 to Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: September 13, 2022; Filing Authority: 39 U.S.C. 3642, 39 CFR 3040.130 through 3040.135, and 39 CFR 3035.105; Public Representative: Christopher C. Mohr; Comments Due: September 21, 2022.

This Notice will be published in the Federal Register .