January 18, 2023 – Federal Register Recent Federal Regulation Documents

National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2023-00868
Type: Notice
Date: 2023-01-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Amended Notice of Meeting
Document Number: 2023-00867
Type: Notice
Date: 2023-01-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2023-00866
Type: Notice
Date: 2023-01-18
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Purchased/Referred Care Delivery Area Redesignation for the Hoh Tribe in the State of Washington
Document Number: 2023-00864
Type: Notice
Date: 2023-01-18
Agency: Department of Health and Human Services, Indian Health Service
This Notice advises the public that the Indian Health Service (IHS) proposes to expand the geographic boundaries of the Purchased/ Referred Care Delivery Area (PRCDA) for the Hoh Tribe in the State of Washington to include the county of Clallam in the State of Washington. The current PRCDA for the Hoh Tribe includes the Washington county of Jefferson. Hoh Tribe members residing outside of the PRCDA are eligible for direct care services, however, they are not eligible for Purchased/ Referred Care (PRC) services. The sole purpose of this expansion would be to authorize additional Hoh Tribe members and beneficiaries to receive PRC services.
Rate Adjustments for Indian Irrigation Projects
Document Number: 2023-00863
Type: Notice
Date: 2023-01-18
Agency: Department of the Interior, Bureau of Indian Affairs
The Bureau of Indian Affairs (BIA) owns or has an interest in irrigation projects located on or associated with various Indian reservations throughout the United States. We are required to establish irrigation assessment rates to recover the costs to administer, operate, maintain, and rehabilitate these projects. We request your comments on the proposed rate adjustments.
Certain Preserved Mushrooms From France Determination
Document Number: 2023-00862
Type: Notice
Date: 2023-01-18
Agency: International Trade Commission, Agencies and Commissions
Emulsion Styrene-Butadiene Rubber From Czechia and Russia; Corrected Determinations
Document Number: 2023-00860
Type: Notice
Date: 2023-01-18
Agency: International Trade Commission, Agencies and Commissions
Correction is made to the date determinations in these investigations were completed and filed.
Certain New Chemicals; Receipt and Status Information for December 2022
Document Number: 2023-00859
Type: Notice
Date: 2023-01-18
Agency: Environmental Protection Agency
EPA is required under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, to make information publicly available and to publish information in the Federal Register pertaining to submissions under TSCA section 5, including notice of receipt of a Premanufacture notice (PMN), Significant New Use Notice (SNUN) or Microbial Commercial Activity Notice (MCAN), including an amended notice or test information; an exemption application (Biotech exemption); an application for a test marketing exemption (TME), both pending and/or concluded; a notice of commencement (NOC) of manufacture (including import) for new chemical substances; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. This document covers the period from 12/1/ 2022 to 12/31/2022.
Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Document Number: 2023-00857
Type: Notice
Date: 2023-01-18
Agency: Federal Reserve System, Agencies and Commissions
Amendments to the Marketing Order for Oranges, Grapefruit, Tangerines, and Pummelos Grown in Florida
Document Number: 2023-00856
Type: Proposed Rule
Date: 2023-01-18
Agency: Agricultural Marketing Service, Department of Agriculture
This rulemaking proposes amendments to Marketing Order 905, which regulates the handling of oranges, grapefruit, tangerines, and pummelos grown in Florida. The proposed amendments reduce the size of the Citrus Administrative Committee (Committee) and lower quorum requirements, revise the nomination and selection processes, remove the requirement to allocate committee seats on the basis of volume from each district, and add a new section to provide the Committee authority to receive voluntary contributions for promotion and research projects. Conforming changes to align the marketing order with the proposed amendments are also proposed.
Reader Aids
Document Number: FR-2023-01-18-ReaderAids
Type: Reader Aids
Date: 2023-01-18
Delegation of Authority Under Section 506(a)(1) of the Foreign Assistance Act of 1961
Document Number: 2023-00985
Type: Administrative Order
Date: 2023-01-18
Agency: Executive Office of the President
Sunshine Act Meetings
Document Number: 2023-00954
Type: Notice
Date: 2023-01-18
Agency: Department of Energy, Federal Energy Regulatory Commission
Sunshine Act Meetings
Document Number: 2023-00935
Type: Notice
Date: 2023-01-18
Agency: International Trade Commission, Agencies and Commissions
Sunshine Act Meetings
Document Number: 2023-00905
Type: Notice
Date: 2023-01-18
Agency: Federal Election Commission, Agencies and Commissions
Virtual Meeting of the Ground Ambulance and Patient Billing Advisory Committee; Cancellation
Document Number: 2023-00903
Type: Notice
Date: 2023-01-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services is cancelling the virtual public meeting of the Ground Ambulance and Patient Billing, which was scheduled for January 17 and 18, 2023.
Implementation of Additional Export Controls: Certain Advanced Computing and Semiconductor Manufacturing Items; Supercomputer and Semiconductor End Use; Entity List Modification; Updates to the Controls To Add Macau
Document Number: 2023-00888
Type: Rule
Date: 2023-01-18
Agency: Department of Commerce, Bureau of Industry and Security
On October 7, 2022, the Bureau of Industry and Security (BIS) updated the Export Administration Regulations (EAR) to implement necessary controls on advanced computing integrated circuits (ICs), computer commodities that contain such ICs, and certain semiconductor manufacturing items, and to make other changes to the EAR to ensure that appropriate controls are in place for these items, including specific activities of ``U.S. persons.'' This rule makes an initial update to the controls to more effectively achieve the policy objectives identified in previous regulations by adding the same controls implemented on China in that rule to Macau. The public may submit comments on the controls in the October 7 advanced computing and semiconductor manufacturing equipment rule, which BIS is extending to Macau in this rule. BIS intends to publish a subsequent rule to respond to the comments received, including making updates to the controls included in the October 7 advanced computing and semiconductor manufacturing equipment rule.
Notice of Intent To Prepare an Environmental Impact Statement for Highly Pathogenic Avian Influenza Control in the United States
Document Number: 2023-00884
Type: Notice
Date: 2023-01-18
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
We are announcing to the public that the Animal and Plant Health Inspection Service (APHIS) intends to prepare an environmental impact statement (EIS) to examine the potential environmental effects of the Agency's response activities to highly pathogenic avian influenza outbreaks in commercial and backyard poultry operations in the United States. APHIS is requesting public comment to further define the scope of the EIS, identify reasonable alternatives and potential issues, as well as relevant information, studies, and/or analyses that APHIS should consider in the EIS.
Foreign Endangered Species; Receipt of Permit Applications
Document Number: 2023-00883
Type: Notice
Date: 2023-01-18
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service, invite the public to comment on applications to conduct certain activities with foreign species that are listed as endangered under the Endangered Species Act (ESA). With some exceptions, the ESA prohibits activities with listed species unless Federal authorization is issued that allows such activities. The ESA also requires that we invite public comment before issuing permits for any activity otherwise prohibited by the ESA with respect to any endangered species.
Marine Mammal Protection Act; Receipt of Permit Application
Document Number: 2023-00882
Type: Notice
Date: 2023-01-18
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service (Service), invite the public to comment on species for which the Service has jurisdiction under the Marine Mammal Protection Act (MMPA). With some exceptions, the MMPA prohibits activities with listed species unless Federal authorization is issued that allows such activities. The MMPA also requires that we invite public comment before issuing a permit for any activity otherwise prohibited with respect to any species.
Civil Monetary Penalty Annual Inflation Adjustment
Document Number: 2023-00881
Type: Rule
Date: 2023-01-18
Agency: National Transportation Safety Board, Agencies and Commissions
Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, this final rule provides the 2023 adjustment to the civil penalties that the agency may assess for violations of certain NTSB statutes and regulations.
Foreign Endangered Species; Receipt of Permit Applications
Document Number: 2023-00880
Type: Notice
Date: 2023-01-18
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service, invite the public to comment on applications to conduct certain activities with foreign species that are listed as endangered under the Endangered Species Act (ESA). With some exceptions, the ESA prohibits activities with listed species unless Federal authorization is issued that allows such activities. The ESA also requires that we invite public comment before issuing permits for any activity otherwise prohibited by the ESA with respect to any endangered species.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2023-00879
Type: Notice
Date: 2023-01-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Information Collection Renewal; Comment Request; Securities Offering Disclosure Rules
Document Number: 2023-00877
Type: Notice
Date: 2023-01-18
Agency: Office of the Comptroller of the Currency, Department of Treasury, Department of the Treasury
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites comment on a continuing information collection as required by the Paperwork Reduction Act of 1995 (PRA). An agency may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is soliciting comment concerning the renewal of an information collection titled ``Securities Offering Disclosure Rules.''
Pendency for Request for Approval of Special Withdrawal Liability Rules: Motion Picture Laboratory Technicians and Film Editors Local 780 Pension Fund
Document Number: 2023-00876
Type: Notice
Date: 2023-01-18
Agency: Pension Benefit Guaranty Corporation, Agencies and Commissions
This notice advises interested persons that the Pension Benefit Guaranty Corporation (PBGC) has received a request from the Motion Picture Laboratory Technicians and Film Editors Local 780 Pension Fund (the ``Plan'') for approval of a plan amendment providing for special withdrawal liability rules. Under PBGC's regulation on Extension of Special Withdrawal Liability Rules, a multiemployer pension plan may, with PBGC approval, be amended to provide for special withdrawal liability rules similar to those that apply to the construction and entertainment industries. Such approval is granted only if PBGC determines that the rules apply to an industry with characteristics that make use of the special rules appropriate and that the rules will not pose a significant risk to the pension insurance system. Before granting an approval, PBGC's regulations require PBGC to give interested persons an opportunity to comment on the request. The purpose of this notice is to advise interested persons of the request and to solicit their views on it.
Board of Visitors for the National Fire Academy
Document Number: 2023-00875
Type: Notice
Date: 2023-01-18
Agency: Federal Emergency Management Agency, Department of Homeland Security
The Board of Visitors for the National Fire Academy (Board) will meet virtually on Wednesday, March 8, 2023, to discuss and support the academic stature of the National Fire Academy. The meeting will be open to the public.
National Institute on Minority Health and Health Disparities; Notice of Closed Meetings
Document Number: 2023-00874
Type: Notice
Date: 2023-01-18
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2023-00873
Type: Notice
Date: 2023-01-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2023-00872
Type: Notice
Date: 2023-01-18
Agency: Department of Health and Human Services, National Institutes of Health
Hazardous Waste Electronic Manifest System (“e-Manifest”) Advisory Board; Notice of Public Meeting
Document Number: 2023-00870
Type: Notice
Date: 2023-01-18
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) will convene the Hazardous Waste Electronic System (``e-Manifest'') Advisory Board for a three (3) day virtual public meeting. The purpose of the meeting is for EPA to seek the Board's consultation and recommendations regarding the e-Manifest system (Meeting Theme: ``Meeting the Needs of the User Community: e-Manifest Program Priorities and User Fees for FY 2024 and 2025'').
Proposed Renewal of the Approval of Information Collection Requirements; Comment Request
Document Number: 2023-00811
Type: Notice
Date: 2023-01-18
Agency: Department of Labor, Office of Federal Contract Compliance Programs
The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre- clearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA). The program helps ensure that 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 on respondents can be properly assessed. The Office of Federal Contract Compliance Programs (OFCCP) is soliciting comments concerning its proposal to obtain approval from the Office of Management and Budget (OMB) for renewal of the information collection for its complaint program. OFCCP is requesting OMB approval for two information collection instruments: revisions to the existing ``Form CC-4, Complaint Involving Employment Discrimination by a Federal Contractor or Subcontractor'' (Form CC-4) and a new instrument, ``Form CC-390 Pre-Complaint Inquiry for Employment Discrimination Involving a Federal Contractor or Subcontractor'' (Form CC-390). The current OMB approval for Form CC-4 expires on May 31, 2023. A copy of the proposed information collection request can be obtained by contacting the office listed below in the FOR FURTHER INFORMATION CONTACT section of this notice or by accessing it at www.regulations.gov.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2023-00810
Type: Notice
Date: 2023-01-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Requirements for Negative Pre- Departure COVID-19 Test Result or Documentation of Recovery from COVID- 19 for all Airline or Other Aircraft Passengers Traveling to the United States from the People's Republic of China (PRC). This data collection is created to protect the U.S. population from potential importation, transmission, and spread of new COVID-19 variants into the United States from the PRC.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2023-00809
Type: Notice
Date: 2023-01-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Vector Surveillance and Control Assessment: Post-Zika Response and Tick Capacities. This study is designed to determine the vector control capabilities of local jurisdictions within the District of Columbia, territories, and 50 states that responded to Zika virus (ZIKV) outbreaks.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2023-00808
Type: Notice
Date: 2023-01-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies to take this opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a new proposed information collection project titled Pre-Shift Lighting Interventions to Improve Miner Safety and Well-Being. The purpose of this information collection is to examine the effect of human centric lighting (HCL) interventions on circadian disruption (CD) and well-being in underground mineworkers.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2023-00807
Type: Notice
Date: 2023-01-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2023-00806
Type: Notice
Date: 2023-01-18
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
30-Day Notice of Proposed Information Collection: Housing Choice Voucher Program and Tribal HUD-VASH, OMB Control No.: 2577-0169
Document Number: 2023-00805
Type: Notice
Date: 2023-01-18
Agency: Department of Housing and Urban Development
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 an additional 30 days of public comment.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2023-00804
Type: Notice
Date: 2023-01-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Endangered and Threatened Species; Take of Abalone
Document Number: 2023-00803
Type: Notice
Date: 2023-01-18
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Notice is hereby given that NMFS has received a request to renew an existing scientific research and enhancement permit for white abalone. The proposed work is intended to increase knowledge of species listed under the Endangered Species Act (ESA) and to help guide management, conservation, and recovery efforts. The application may be viewed online at: https://apps.nmfs.noaa.gov/preview/ preview_open_for_comment.cfm.
Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to the Replacement of Pier 3 at Naval Station Norfolk in Norfolk, Virginia
Document Number: 2023-00801
Type: Notice
Date: 2023-01-18
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that NMFS has issued a modified incidental harassment authorization (IHA) to the U.S. Navy to incidentally harass, by Level A and Level B harassment, marine mammals during construction activities associated with the replacement of Pier 3 at Naval Station Norfolk at Norfolk, Virginia.
Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Naval Base Point Loma Fuel Pier Inboard Pile Removal Project
Document Number: 2023-00800
Type: Notice
Date: 2023-01-18
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA), as amended, notification is hereby given that NMFS has issued a renewal incidental harassment authorization (IHA) to the United States Navy (Navy) to incidentally harass marine mammals incidental to Fuel Pier Inboard Pile Removal Project at Naval Base Point Loma in San Diego Bay, CA.
Extension of, and New Combined Petition Option for Participation in, the Expanded Collaborative Search Pilot Program
Document Number: 2023-00799
Type: Notice
Date: 2023-01-18
Agency: Department of Commerce, Patent and Trademark Office
To speed up patent examination and give applicants more comprehensive prior art by combining the search expertise of United States Patent and Trademark Office (USPTO), Japan Patent Office (JPO), and Korean Intellectual Property Office (KIPO) examiners before issuing a first Office action, the USPTO, in partnership with the JPO and the KIPO, is extending the Expanded Collaborative Search Pilot (CSP) program for an additional two years, through October 31, 2024. Requests to participate in the Expanded CSP program that were filed between October 31, 2022, and January 18, 2023, will be considered. In addition, the partner intellectual property (IP) offices have collaborated on a new petition option for participation in the Expanded CSP program. The new petition option, which has several enhancements compared to the current petition form and process, permits an applicant to file a combined petition in either the USPTO or one of the partner IP offices rather than separate petitions in each office. Enhancements include a more user-friendly layout, the addition of multilingual text, and a foundation for data collection that both satisfies the petition requirements and streamlines the process for partaking in the Expanded CSP program.
Fisheries of the Northeastern United States; Atlantic Herring Fishery; 2023 Management Area 3 Possession Limit Adjustment
Document Number: 2023-00798
Type: Rule
Date: 2023-01-18
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is implementing a 2,000-lb (907.2-kg) possession limit for Atlantic herring for Management Area 3. This is required because NMFS projects that herring catch from Area 3 will reach 98 percent of the Area's sub-annual catch limit before the end of the fishing year. This action is intended to prevent overharvest of herring in Area 3, which would result in additional catch limit reductions in a subsequent year.
Notice of Public Meeting of the Indiana Advisory Committee to the U.S. Commission on Civil Rights
Document Number: 2023-00797
Type: Notice
Date: 2023-01-18
Agency: Commission on Civil Rights
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Indiana Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold planning meetings. The purpose of these meetings is to plan, discuss, and vote, as needed, on matters related to the Committee's civil rights project.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2023-00796
Type: Notice
Date: 2023-01-18
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Supporting and Evaluating the Dissemination and Implementation of PCOR to Improve Non-Surgical Treatment of Urinary Incontinence Among Women in Primary Care.'' This proposed information collection was previously published in the Federal Register on October 28, 2022 and allowed 60 days for public comment. AHRQ received no substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2023-00795
Type: Notice
Date: 2023-01-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Increase the Duration of Aircraft Registration; Confirmation of Effective Date and Correction
Document Number: 2023-00794
Type: Rule
Date: 2023-01-18
Agency: Federal Aviation Administration, Department of Transportation
This action confirms the January 23, 2023, effective date of the Increase the Duration of Aircraft Registration direct final rule published on November 22, 2022, and responds to public comments received regarding the published rule. The direct final rule extends the duration of aircraft registration certificates from three years to seven years. Initial Certificates of Aircraft Registration will expire seven years from the month issued. The FAA is applying this amendment to all aircraft currently registered under existing FAA regulations governing aircraft registration, which will extend valid Certificates of Aircraft Registration to a seven-year duration. This rulemaking also makes other minor revisions to rules related to internal FAA registration processes.
Determination That OFIRMEV (Acetaminophen) Injection, 1,000 Milligrams/100 Milliliters (10 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2023-00792
Type: Notice
Date: 2023-01-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) has determined that OFIRMEV (acetaminophen) injection, 1,000 milligrams (mg)/100 milliliters (mL) (10 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for acetaminophen injection, 1,000 mg/100 mL (10 mg/mL), if all other legal and regulatory requirements are met.
Gabriel J. Letizia, Jr.: Final Debarment Order
Document Number: 2023-00791
Type: Notice
Date: 2023-01-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Gabriel J. Letizia, Jr. from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Letizia was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Letizia was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why he should not be debarred within the timeframe prescribed by regulation. Mr. Letizia has not responded to the notice. Mr. Letizia's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.
Rules of Practice and Procedure; Adjusting Civil Money Penalties for Inflation
Document Number: 2023-00790
Type: Rule
Date: 2023-01-18
Agency: Farm Credit System Insurance Corporation, Agencies and Commissions
This rule implements inflation adjustments to civil money penalties (CMPs) that the Farm Credit System Insurance Corporation (FCSIC) may impose under the Farm Credit Act of 1971, as amended. These adjustments are required by 2015 amendments to the Federal Civil Penalties Inflation Adjustment Act of 1990.
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