March 2, 2022 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 106
Pre-Launch Activities Importation Requests; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Pre-Launch Activities Importation Requests (PLAIR).'' This guidance finalizes and updates the draft guidance of the same title issued on July 24, 2013. This guidance finalizes FDA's approach for overseeing requests regarding the importation of unapproved finished dosage form drug products by applicants preparing products for market launch based on anticipated approval of a pending new drug application (NDA) or an abbreviated new drug application (ANDA). This guidance also applies to biologics licensing applications (BLAs) regulated by the Center for Drug Evaluation and Research. This guidance further describes the procedures for making these requests and FDA's actions on such requests. Finalizing this policy will help increase efficiencies in ensuring timely access to drug products upon approval.
Maintenance Plan and Redesignation Request; Nogales PM2.5
The Environmental Protection Agency (EPA) is proposing to approve the ``FINAL SIP Revision: Nogales PM2.5 Maintenance Plan and Redesignation Request (2006 Fine Particulate NAAQS)'' (``Nogales Maintenance Plan'' or ``Plan'') as a revision to the state implementation plan (SIP) for the State of Arizona. The Nogales Maintenance Plan includes, among other elements, an emissions inventory consistent with attainment, a maintenance demonstration, contingency provisions, and a motor vehicle emissions budget for the ten-year maintenance period. The EPA is also proposing to approve the State of Arizona's request to redesignate the Nogales area from nonattainment to attainment for the 24-hour national ambient air quality standard (NAAQS or ``standard'') for particulate matter of 2.5 micrometers or less (PM2.5). The EPA is proposing these actions because this SIP revision meets the applicable Clean Air Act (CAA or ``Act'') requirements for maintenance plans and because the State has met the requirements under the Act for redesignation of a nonattainment area to attainment with respect to the Nogales area.
Energy Conservation Program: Test Procedure for Television Sets
The U.S. Department of Energy (``DOE'') proposes to amend the test procedures for television sets to incorporate by reference the relevant updated industry standard. DOE has tentatively determined that the proposed updates would result in a test procedure that is more representative of the average energy use of television sets. DOE is seeking comment from interested parties on the proposal.
Fisheries of the Exclusive Economic Zone Off Alaska; Gulf of Alaska; Final 2022 and 2023 Harvest Specifications for Groundfish
NMFS announces final 2022 and 2023 harvest specifications, apportionments, and Pacific halibut prohibited species catch limits for the groundfish fishery of the Gulf of Alaska (GOA). This action is necessary to establish harvest limits for groundfish during the remainder of the 2022 and the start of the 2023 fishing years and to accomplish the goals and objectives of the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP). The 2022 harvest specifications supersede those previously set in the final 2021 and 2022 harvest specifications, and the 2023 harvest specifications will be superseded in early 2023 when the final 2023 and 2024 harvest specifications are published. The intended effect of this action is to conserve and manage the groundfish resources in the GOA in accordance with the Magnuson- Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).
Debt Collection Authorities Under the Debt Collection Improvement Act of 1996
The Department of the Treasury (``Treasury''), Bureau of the Fiscal Service (``Fiscal Service''), proposes to amend its regulations regarding the Treasury Offset Program (``TOP'') and the Cross-Servicing program. The primary reason for doing so is to inform the public about how Fiscal Service will use Social Security numbers in mailings, as required by the Social Security Number Fraud Prevention Act of 2017, which requires Fiscal Service to have final regulations in place by September 15, 2022.
Magnuson-Stevens Act Provisions; Fisheries Off West Coast States; Pacific Coast Groundfish Fishery; Pink Shrimp and Midwater Trawl Exemptions to Vessel Monitoring System Requirements for the West Coast Groundfish Fishery
This rule revises monitoring provisions that specify exemptions for non-groundfish trawl vessels participating in the Pacific coast pink shrimp fishery and for groundfish midwater trawl vessels. In a final rule on vessel movement, monitoring, and declaration management for the Pacific coast groundfish fishery published on June 11, 2020, vessels in the pink shrimp trawl fishery were incorrectly included with other open access non-groundfish trawl vessels that became subject to a higher position transmission rate on their NMFS type-approved vessel monitoring system (VMS) units. This final rule corrects the error and returns the required transmission rate for vessels in the pink shrimp trawl fishery to once every 60 minutes, as recommended by the Pacific Fishery Management Council (Council). This action also corrects a citation error in the VMS regulations with regards to exemptions for midwater trawl vessels, as well as a typographical error in the trawl fishery prohibitions.
Magnuson-Stevens Fishery Conservation and Management Act Provisions; Fisheries of the Northeastern United States; Atlantic Herring Fishery; Framework Adjustment 9
This action proposes to approve and implement Framework Adjustment 9 to the Atlantic Herring Fishery Management Plan. This proposed rule would establish a rebuilding plan for herring, adjust accountability measure catch threshold triggers when catch exceeds a herring annual catch limit or management area sub-annual catch limit, and revise existing regulations to clarify area closure and possession limit restrictions and add prohibitions that were inadvertently omitted from previous management actions. This action is necessary to respond to updated scientific information and to achieve the goals and objectives of the fishery management plan. The proposed measures are intended to help prevent overfishing, rebuild the overfished herring stock, achieve optimum yield, and ensure that management measures are based on the best scientific information available.
Fisheries of the Exclusive Economic Zone Off Alaska; Bering Sea and Aleutian Islands; Final 2022 and 2023 Harvest Specifications for Groundfish
NMFS announces final 2022 and 2023 harvest specifications, apportionments, and prohibited species catch allowances for the groundfish fishery of the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to establish harvest limits for groundfish during the remainder of the 2022 and the start of the 2023 fishing years and to accomplish the goals and objectives of the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP). The 2022 harvest specifications supersede those previously set in the final 2021 and 2022 harvest specifications, and the 2023 harvest specifications will be superseded in early 2023 when the final 2023 and 2024 harvest specifications are published. The intended effect of this action is to conserve and manage the groundfish resources in the BSAI in accordance with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).
Taking of Marine Mammals Incidental to Commercial Fishing Operations; Atlantic Large Whale Take Reduction Plan Regulations
NMFS is implementing a temporary emergency rule to prohibit trap/pot fishery buoy lines between Federal and State waters within the Massachusetts Restricted Area during the month of April 2022 to reduce the incidental mortality and serious injury to North Atlantic right whales (Eubalaena glacialis) in commercial lobster and Jonah crab trap/ pot fisheries. This emergency rule is necessary to reduce the risk of right whale mortality and serious injury in buoy lines in an area with a high co-occurrence of whales and buoy lines.
Proposed Revocation of Colored Federal Airway Blue 26 (B-26); Fort Yukon, AK
This action proposes to revoke Colored Federal airway Blue 26 (B-26) in the vicinity of Fort Yukon, AK due to the pending decommissioning of the Yukon River, AK, (FTO) Non-directional Beacon (NDB).
General Services Administration Acquisition Regulation (GSAR); Order Level Material Clarifications
The General Services Administration (GSA) is issuing a final rule amending the General Services Administration Acquisition Regulation (GSAR) to remove unnecessary language regarding approvals and travel and to correct citation and acronym references relating to order level materials.
Energy Conservation Program: Energy Conservation Standards for Electric Motors, Webinar and Availability of the Preliminary Technical Support Document
The U.S. Department of Energy (``DOE'' or ``the Department'') will hold a webinar to discuss and receive comments on the preliminary analysis it has conducted for purposes of evaluating energy conservation standards for electric motors. The meeting will cover the analytical framework, models, and tools used to evaluate potential standards for this equipment; the results of preliminary analyses performed for this equipment; the potential energy conservation standard levels derived from these analyses that may be considered for this equipment should proposed amendments be determined necessary; and any other issues relevant to the evaluation of energy conservation standards for electric motors. Written comments on these subjects from the public are encouraged.
Tariff of Tolls
The Great Lakes St. Lawrence Seaway Development Corporation (GLS) and the St. Lawrence Seaway Management Corporation (SLSMC) of Canada, under international agreement, jointly publish and presently administer the St. Lawrence Seaway Tariff of Tolls in their respective jurisdictions. The Tariff sets forth the level of tolls assessed on all commodities and vessels transiting the facilities operated by the GLS and the SLSMC. The GLS is revising its regulations to reflect the fees and charges levied by the SLSMC in Canada starting in the 2022 navigation season, which are effective only in Canada. An amendment to increase the minimum charge per lock for those vessels that are not pleasure craft or subject in Canada to tolls under items 1 and 2 of the Tariff for full or partial transit of the Seaway will apply in the U.S. (See SUPPLEMENTARY INFORMATION). The Tariff of Tolls will be effective on March 21, 2022 in Canada.
Safety Zone; Military Ocean Terminal Concord Safety Zone, Suisun Bay, Military Ocean Terminal Concord, CA
The Coast Guard will enforce the safety zone in the navigable waters of Suisun Bay, off Concord, CA, in support of explosive off and on-loading to Military Ocean Terminal Concord (MOTCO) from March 3 through March 8, 2022. This safety zone is necessary to protect personnel, vessels, and the marine environment from potential explosion within the explosive arc. The safety zone is open to all persons and vessels for transitory use, but vessel operators desiring to anchor or otherwise loiter within the safety zone must obtain the permission of the Captain of the Port San Francisco or a designated representative. All persons and vessels operating within the safety zone must comply with all directions given to them by the Captain of the Port (COTP) San Francisco or a designated representative.
Codex Alimentarius Commission: Meeting of the Codex Committee on Pesticide Residues
The U.S. Codex Office is sponsoring a public meeting on June 2, 2022. The objective of the public meeting is to provide information and receive public comments on agenda items and draft United States (U.S.) positions to be discussed at the 53rd Session of the Codex Committee on Pesticide Residues (CCPR) of the Codex Alimentarius Commission (CAC), which will convene virtually, July 4-July 13, 2022. The U.S. Manager for Codex Alimentarius and the Acting Deputy Under Secretary for Trade and Foreign Agricultural Affairs recognize the importance of providing interested parties the opportunity to obtain background information on the 53rd Session of the CCPR and to address items on the agenda.
Notice of OFAC Sanctions Actions
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC's determination that one or more applicable legal criteria were satisfied. Additionally, OFAC is publishing updates to the identifying information of one person currently included on the SDN List. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
Certain Products Containing Pyraclostrobin and Components Thereof Notice of Institution
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on January 28, 2022, under section 337 of the Tariff Act of 1930, as amended, on behalf of BASF SE of Germany and BASF Corporation, Florham Park, New Jersey. A supplement to the Complaint was filed on February 15, 2022. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain products containing pyraclostrobin and components thereof by reason of infringement of certain claims of U.S. Patent No. 7,816,392 (``the '392 patent''). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
Notice of OFAC Sanctions Actions
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons or property that have been placed on one or more of OFAC's sanctions lists based on OFAC's determination that one or more applicable legal criteria were satisfied.
Revised Non-Foreign Overseas Per Diem Rates
Defense Human Resources Activity publishes this Civilian Personnel Per Diem Bulletin Number 320. Bulletin Number 320 lists current per diem rates prescribed for reimbursement of subsistence expenses while on official Government travel to Alaska, Hawaii, the Commonwealth of Puerto Rico, and the possessions of the United States. The Fiscal Year (FY) 2022 lodging rate review for Guam, the Northern Mariana Islands and the U.S. Virgin Islands resulted in a rate change for the Tinian, Northern Mariana Islands. All other rates remain the same.
Meeting of the Vaccines Federal Implementation Plan
The Department of Health and Human Services' Office of Infectious Disease and HIV/AIDS Policy in the Office of the Assistant Secretary for Health announces that the draft Vaccines Federal Implementation Plan 2021-2025 is available for public comment. The Vaccines Federal Implementation Plan is a companion document to the Vaccines National Strategic Plan 2021-2025 (VNSP), which was published in January 2021. The Vaccines Federal Implementation Plan is a compilation of federal agency immunization activities that collectively advance the goals of the VNSP. Its target audience is other federal agencies and external partners who work in the area of vaccination. The public will be interested in how the implementation plan documents federal agency efforts. It does not outline mandates or other COVID-19 response measures.
Bulk Manufacturer of Controlled Substances Application: Sterling Pharma USA, LLC
Sterling Pharma USA, LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Entry/Immediate Delivery Application and ACE Cargo Release
The Department of Homeland Security, U.S. Customs and Border Protection will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). The information collection is published in the Federal Register to obtain comments from the public and affected agencies.
Global Business Identifier (GBI)
The Department of Homeland Security, U.S. Customs and Border Protection will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). The information collection is published in the Federal Register to obtain comments from the public and affected agencies.
Importer of Controlled Substances Application: Janssen Pharmaceuticals, Inc.
Janssen Pharmaceuticals Inc., has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
30-Day Notice of Proposed Information Collection: Coronavirus Aid, Relief, and Economic Security (CARES) Act Reporting
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 30 days of public comment.
60-Day Notice of Proposed Information Collection: Statement of Registration
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.
Proposed Collection; Comment Request; Correction
The Department of Defense is correcting a notice that appeared in the Federal Register on February 23, 2022. Subsequent to publication of the notice, the DoD discovered that the Docket ID was not listed correctly. DoD is issuing this correction to provide the correct Docket ID.
Submission for OMB Review; State Self-Assessment Review and Report
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF) requests a three-year extension of the State Self-Assessment Review and Report with minor revisions. The information collected in the reports assists state child support enforcement agencies and OCSE in determining whether the agencies meet federal child support performance requirements. The current Office of Management and Budget (OMB) approval expires April 30, 2022.
Construction Standards on Posting Emergency Telephone Numbers and Floor Load Limits; Extension of the Office of Management and Budget's (OMB) Approval of Information Collection (Paperwork) Requirements
OSHA solicits public comments concerning the proposal to extend the Office of Management and Budget's (OMB) approval of the information collection requirements specified in the Construction Standards on Posting Emergency Telephone Numbers and Maximum Safe Floor Load Limits.
Television Broadcasting Services Toledo, Ohio
On March 22, 2021, the Media Bureau, Video Division (Bureau) issued a Notice of Proposed Rulemaking (NPRM) in response to a petition for rulemaking filed by Dominion Broadcasting, Inc. (Petitioner), the licensee of WLMB, channel 5, Toledo, Ohio, requesting the substitution of channel 35 for channel 5 at Toledo in the Table of Allotments. For the reasons set forth in the Report and Order referenced below, the Bureau amends Federal Communications Commission (Commission or FCC) regulations to substitute channel 35 for channel 5 at Toledo.
Board of Directors Meeting
Notice of the forthcoming regular meeting of the Board of Directors of the Farm Credit System Insurance Corporation (FCSIC), is hereby given in accordance with the provisions of Article VI of the Bylaws of the FCSIC.
Extended Mail Forwarding Service
The Postal Service is amending Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM[supreg]) section 507.2.0 to add a new product offering that will allow customers to extend mail forwarding service.
Submission for OMB Review; Improving Customer Experience (OMB Circular A-11, Section 280 Implementation)
The General Services Administration (GSA) has under OMB review the following proposed Information Collection Request ``Improving Customer Experience (OMB Circular A-11, Section 280 Implementation)'' for approval under the Paperwork Reduction Act (PRA).
Extension of the Application Deadline Date; Applications for New Awards; Alaska Native Education Program
On January 12, 2022, the Department of Education (Department) published in the Federal Register a notice inviting applications (NIA) for the fiscal year (FY) 2022 Alaska Native Education (ANE) program competition, Assistance Listing Number 84.356A. The ANE NIA established a deadline date of March 14, 2022, for transmittal of applications. This notice extends the FY 2022 application deadline date to April 26, 2022. This notice relates to the approved information collections under OMB control numbers 1894-0006 and 1840-0842.
COVID-19 Related Relief Concerning International Operations at Chicago O'Hare International Airport, John F. Kennedy International Airport, Los Angeles International Airport, Newark Liberty International Airport, New York LaGuardia Airport, Ronald Reagan Washington National Airport, and San Francisco International Airport for the Summer 2022 Scheduling Season
The FAA proposes to extend through October 29, 2022, the Coronavirus (COVID-19)-related limited, conditional waiver of the minimum slot usage requirement at John F. Kennedy International Airport (JFK), New York LaGuardia Airport (LGA), and Ronald Reagan Washington National Airport (DCA) that the FAA has already made available through March 26, 2022, for international operations only. Similarly, the FAA proposes to extend through October 29, 2022, its COVID-19-related limited, conditional policy for prioritizing flights canceled at designated International Air Transport Association (IATA) Level 2 airports in the United States, for purposes of establishing a carrier's operational baseline in the next corresponding season, for international operations only. These IATA Level 2 airports include Chicago O'Hare International Airport (ORD), Los Angeles International Airport (LAX), Newark Liberty International Airport (EWR), and San Francisco International Airport (SFO). This relief would be limited to slots and approved operating times used by any carrier for international operations only, through October 29, 2022, and would be subject to the same terms and conditions, that the FAA has already applied to the relief that remains available through March 26, 2022.
Agency Information Collection Activities: Requests for Comments; Clearance of a New Approval of Information Collection: Inspection Authorization Refresher Course Acceptance Form
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval for a new information collection. The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on April 29, 2021. The collection is from persons or entities that desire to provide Inspection Authorization (IA) refresher courses for the purpose of IA renewal. The course providers complete FAA Form 8610-6 to substantiate their courses and administrative procedures are acceptable to the FAA Administrator.
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