March 2023 – Federal Register Recent Federal Regulation Documents

Results 101 - 150 of 2,620
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2023-06737
Type: Notice
Date: 2023-03-31
Agency: National Archives and Records Administration, Agencies and Commissions
We are proposing to request an extension from the Office of Management and Budget (OMB) of one currently approved information collection, consisting of National Archives Trust Fund (NATF) Order Forms for Genealogical Research in the National Archives. The NATF forms included in this information collection are: NATF 84, National Archives Order for Copies of Land Entry Files; NATF 85, National Archives Order for Copies of Pension or Bounty Land Warrant Applications; and NATF 86, National Archives Order for Copies of Military Service Records. Pursuant to the Paperwork Reduction Act of 1995, we invite you to comment on this proposed combined information collection.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2023-06736
Type: Notice
Date: 2023-03-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
East Ohio Valley Railway LLC-Acquisition and Operation Exemption-Ohio River Partners Shareholder LLC
Document Number: 2023-06735
Type: Notice
Date: 2023-03-31
Agency: Surface Transportation Board, Department of Transportation
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2023-06734
Type: Notice
Date: 2023-03-31
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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Validated Follow-up Interview of Clinicians on Outpatient Antibiotic Stewardship Interventions. This collection aims to perform an interview of outpatient clinicians regarding the acceptability and perceived clinician-level barriers associated with our year-long implementation of interventions designed around the Core Elements of Outpatient Antibiotic Stewardship.
Notice of Meeting of the EPA Children's Health Protection Advisory Committee (CHPAC)
Document Number: 2023-06733
Type: Notice
Date: 2023-03-31
Agency: Environmental Protection Agency
Pursuant to the provisions of the Federal Advisory Committee Act, notice is hereby given that the next meeting of the Children's Health Protection Advisory Committee (CHPAC) will be held virtually and in-person on May 17 and 18, 2023 at the U.S. Environmental Protection Agency (EPA) Headquarters located at 1200 Pennsylvania Avenue NW, Washington, DC 20460. The CHPAC advises EPA on science, regulations and other issues relating to children's environmental health.
Proposed Information Collection Request; Comment Request; Regional Haze Regulations (Renewal)
Document Number: 2023-06732
Type: Notice
Date: 2023-03-31
Agency: Environmental Protection Agency
The Environmental Protection Agency is planning to submit an information collection request (ICR), ``Renewal of the ICR for the Regional Haze Regulations'' (EPA ICR No. 2540.04 OMB Control No. 2060- 0704) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA). Before doing so, the EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through September 30, 2023. An Agency may not conduct, or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Environmental Management Site-Specific Advisory Board, Idaho Cleanup Project
Document Number: 2023-06728
Type: Notice
Date: 2023-03-31
Agency: Department of Energy
This notice announces an in-person/virtual hybrid meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Idaho Cleanup Project (ICP). The Federal Advisory Committee Act requires that public notice of this meeting be announced in the Federal Register.
Fortress Investment Group LLC et al.-Continuance in Control Exemption-East Ohio Valley Railway LLC
Document Number: 2023-06727
Type: Notice
Date: 2023-03-31
Agency: Surface Transportation Board, Department of Transportation
Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting
Document Number: 2023-06726
Type: Notice
Date: 2023-03-31
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Mid-Atlantic Fishery Management Council's Tilefish Advisory Panel will hold a public meeting.
Agency Information Collection Extension; Correction
Document Number: 2023-06725
Type: Notice
Date: 2023-03-31
Agency: Department of Energy
On January 19, 2023, the Office of Sustainability and Asset Management, Department of Energy, published a request for comments in the Federal Register on a proposed collection of information that DOE is developing for submission to the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995.
Airworthiness Directives; Airbus SAS Airplanes
Document Number: 2023-06493
Type: Proposed Rule
Date: 2023-03-30
Agency: Federal Aviation Administration, Department of Transportation
The FAA proposes to adopt a new airworthiness directive (AD) for all Airbus SAS Model A350-941 and -1041 airplanes. This proposed AD was prompted by reports of a non-full life clearance in the low- pressure hydraulic pipes of the nose landing gear return line, due to two quality escapes. This proposed AD would require replacing the affected aluminum pipes with titanium pipes, as specified in a European Union Aviation Safety Agency (EASA) AD, which is proposed for incorporation by reference (IBR). This proposed AD would also prohibit the installation of affected parts. The FAA is proposing this AD to address the unsafe condition on these products.
Airworthiness Directives; Airbus Canada Limited Partnership (Type Certificate Previously Held by C Series Aircraft Limited Partnership (CSALP); Bombardier, Inc.) Airplanes
Document Number: 2023-06492
Type: Proposed Rule
Date: 2023-03-30
Agency: Federal Aviation Administration, Department of Transportation
The FAA proposes to adopt a new airworthiness directive (AD) for certain Airbus Canada Limited Partnership Model BD-500-1A10 and BD- 500-1A11 airplanes. This proposed AD was prompted by reports that, during instrument landing system (ILS) approaches, the flight control system reverted from primary flight control computer (PFCC) normal mode operating in autopilot to remote electronics unit (REU) direct mode, and then, after a period of time, to PFCC direct mode. This proposed AD would require installation of a PFCC software update; and a records review or detailed inspection to identify pre-existing repairs or damage within certain limits to certain structures, and obtaining and following additional instructions if necessary; as specified in a Transport Canada AD, which is proposed for incorporation by reference (IBR). The FAA is proposing this AD to address the unsafe condition on these products.
Energy Conservation Program: Energy Conservation Standards for Consumer Conventional Cooking Products; Extension of Public Comment Period
Document Number: 2023-06486
Type: Notice
Date: 2023-03-30
Agency: Department of Energy
On February 1, 2023, the U.S. Department of Energy (``DOE'') published a supplemental notice of proposed rulemaking (``SNOPR'') and announcement of public meeting proposing amended energy conservation standards for conventional cooking products and announcing a public meeting to receive comment on the proposed standards and associated analyses and results. (``February 2023 SNOPR'') The notice provided an opportunity for submitting written comments, data, and information by April 3, 2023. DOE received a request from the Association of Home Appliance Manufacturers (AHAM) to extend the written comment period. DOE has reviewed this request and is granting a 14-day extension of the public comment period to allow comments to be submitted until April 17, 2023.
Air Plan Approval; Idaho: Inspection and Maintenance Program Removal
Document Number: 2023-06461
Type: Proposed Rule
Date: 2023-03-30
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) proposes to approve revisions to the Idaho State Implementation Plan (SIP) submitted by the State of Idaho (Idaho or the State) on December 29, 2022. The proposed revision, applicable in the Boise-Northern Ada County Carbon Monoxide area (Northern Ada County CO area) in Idaho, removes the Inspection and Maintenance (I/M) program, which was previously approved into the SIP for use as a control measure in the State's plan to address motor vehicle emissions in the nonattainment area. The SIP submission includes a demonstration that the requested revision will not interfere with attainment or maintenance of any national ambient air quality standard (NAAQS) or with any other applicable requirement of the Clean Air Act (CAA or Act). The EPA evaluated whether this SIP revision would interfere with the requirements of the CAA and is proposing to determine that Idaho's December 29, 2022, SIP revision is consistent with the applicable portions of the CAA.
Civil Penalty Adjustments
Document Number: 2023-06414
Type: Rule
Date: 2023-03-30
Agency: National Foundation on the Arts and Humanities, National Endowment for the Humanities
The National Endowment for the Humanities (NEH) is adjusting the maximum and minimum civil monetary penalties that may be imposed for violations of its New Restrictions on Lobbying and Program Fraud Civil Remedies Act regulations to reflect the requirements of the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. This final rule provides the 2023 annual inflation adjustments to the initial ``catch-up'' adjustments made on April 21, 2020, and August 13, 2021, and reflects all other inflation adjustments made in the interim. This final rule also codifies the statutory formula for inflation adjustments in NEH's New Restrictions on Lobbying and Program Fraud Civil Remedies Act regulations, so that NEH may publish a Notice in the Federal Register indicating the civil monetary penalty adjustment amounts for each regulation in January 2024 and every calendar year thereafter.
Endangered and Threatened Wildlife and Plants; Threatened Species Status With Section 4(d) Rule for Egyptian Tortoise
Document Number: 2023-06312
Type: Rule
Date: 2023-03-30
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service (Service), are listing the Egyptian tortoise (Testudo kleinmanni; syn. Testudo werneri), a terrestrial tortoise from Libya, Egypt, and Israel, as a threatened species with a rule issued under section 4(d) of the Endangered Species Act of 1973 (Act), as amended. The rule issued under section 4(d) of the Act provides measures that are necessary and advisable to provide for the conservation of this species.
Energy Conservation Program: Energy Conservation Standards for Variable Refrigerant Flow Multi-Split Air Conditioners and Heat Pumps
Document Number: 2023-06178
Type: Rule
Date: 2023-03-30
Agency: Department of Energy
The Energy Policy and Conservation Act, as amended (EPCA), prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including small, large, and very large commercial package air conditioning and heating equipment, of which variable refrigerant flow (VRF) multi-split air conditioners and VRF multi-split system heat pumps (collectively referred to as ``VRF multi-split systems'') are a category. EPCA requires the U.S. Department of Energy (DOE or the Department) to consider the need for amended standards each time American Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE) Standard 90.1 is amended with respect to the standard levels or design requirements applicable to that equipment, or periodically under a six- year-lookback review provision. In this final rule, DOE is adopting amended energy conservation standards for VRF multi-split systems that rely on a new cooling efficiency metric and are equivalent to those levels specified in ASHRAE Standard 90.1. DOE has determined that it lacks the clear and convincing evidence required by the statute to adopt standards more stringent than the levels specified in the industry standard.
Federal Acquisition Regulation: Credit for Lower-Tier Small Business Subcontracting
Document Number: 2023-06172
Type: Proposed Rule
Date: 2023-03-30
Agency: Department of Defense, General Services Administration, Agencies and Commissions, National Aeronautics and Space Administration
DoD, GSA, and NASA are withdrawing this proposed rule. The decision not to proceed with a final rule was made because the underlying statute has been changed. Accordingly, this proposed rule is withdrawn, and the FAR case is closed.
Conserving the Natural and Cultural Heritage of the Pacific Remote Islands
Document Number: X23-10330
Type: Administrative Order
Date: 2023-03-30
Agency: Executive Office of the President
Reader Aids
Document Number: FR-2023-03-30-ReaderAids
Type: Reader Aids
Date: 2023-03-30
Continuation of the National Emergency With Respect to South Sudan
Document Number: 2023-06882
Type: Administrative Order
Date: 2023-03-30
Agency: Executive Office of the President
Honoring the Victims of the Tragedy in Nashville, Tennessee
Document Number: 2023-06866
Type: Proclamation
Date: 2023-03-30
Agency: Executive Office of the President
2023-06837
Document Number: 2023-06837
Type: Administrative Order
Date: 2023-03-30
Agency: Executive Office of the President
General Rules and Regulations, Securities Exchange Act of 1934
Document Number: 2023-06701
Type: Rule
Date: 2023-03-30
Agency: Securities and Exchange Commission, Agencies and Commissions
Additions to the Entity List; Amendment To Confirm Basis for Adding Certain Entities to the Entity List Includes Foreign Policy Interest of Protection of Human Rights Worldwide
Document Number: 2023-06663
Type: Rule
Date: 2023-03-30
Agency: Department of Commerce, Bureau of Industry and Security
In this rule, the Bureau of Industry and Security (BIS) amends the Export Administration Regulations (EAR) by adding eleven entities to the Entity List under the destinations of Burma, the People's Republic of China (China), Nicaragua, and Russia. These eleven entities have been determined by the U.S. Government to be acting contrary to the national security or foreign policy interests of the United States. In this rule, BIS also amends the EAR to explicitly confirm that the foreign policy interest of protecting human rights worldwide is a basis for adding entities to the Entity List.
Agency Information Collection Activities; Submission to the Office of Management and Budget (OMB) for Review and Approval; Comment Request; Applications for Inclusion on the Lists of Arbitrators Under the Data Privacy Framework Program
Document Number: 2023-06647
Type: Notice
Date: 2023-03-30
Agency: Department of Commerce, International Trade Administration
The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment preceding submission of the collection to OMB.
Cybersecurity in Medical Devices: Refuse To Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2023-06646
Type: Notice
Date: 2023-03-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled ``Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under section 524B of the FD&C Act of the FD&C Act.'' FDA generally intends not to issue ``refuse to accept'' (RTA) decisions for premarket submissions submitted for cyber devices based solely on information required by the new amendments to the FD&C Act for ensuring cybersecurity of devices before October 1, 2023, but instead, work collaboratively with sponsors of such premarket submissions as part of the interactive and/or deficiency review process.
Agency Information Collection Activities; Submission to the Office of Management and Budget (OMB) for Review and Approval; Comment Request; Self-Certifications Under the Data Privacy Framework Program
Document Number: 2023-06645
Type: Notice
Date: 2023-03-30
Agency: Department of Commerce, International Trade Administration
The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment preceding submission of the collection to OMB.
Privacy Act of 1974; System of Records
Document Number: 2023-06644
Type: Notice
Date: 2023-03-30
Agency: Department of Defense, Office of the Secretary
In accordance with the Privacy Act of 1974, the DoD is establishing a new Department-wide system of records, titled ``DoD Patron Authorization, Retail and Service Activities,'' DoD-0018. This system of records covers DoD's maintenance of records about eligible patron authorizations and transactional information associated with retail purchases and services. Retail includes goods and services provided by any DoD organization to authorized patrons including those who are authorized based on Department affiliation.
Notice of Determinations; Culturally Significant Objects Being Imported for Exhibition-Determinations: Exhibition of “The Encounter: Barbara Chase-Ribound and Alberto Giacommetti”
Document Number: 2023-06643
Type: Notice
Date: 2023-03-30
Agency: Department of State
Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to an agreement with their foreign owner or custodian for temporary display in exhibition ``The Encounter: Barbara Chase-Ribound and Alberto Giacommetti'' at The Museum of Modern Art, New York, New York, and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the Federal Register.
Opportunities in 2023 for United States Grain Standards Act Designation in Jamestown, ND; Lincoln, Nebraska; Memphis, Tennessee; Topeka, KS; Cedar Rapids, IA; Minot, ND; Cincinnati, OH; Pocatello, ID; Evansville, IN; West Sacramento, CA and Richmond, VA; Intent To Certify Delegated Agencies Virginia Department of Agriculture and Consumer Services and Wisconsin Department of Agriculture
Document Number: 2023-06642
Type: Notice
Date: 2023-03-30
Agency: Agricultural Marketing Service, Department of Agriculture
The United States Grain Standards Act (USGSA) designations of the official agencies listed in SUPPLEMENTARY INFORMATION below will end on the prescribed dates. The Agricultural Marketing Service (AMS) is seeking persons or governmental agencies interested in providing official services in the areas presently served by these agencies to apply for designation. Designation provides for private entities or state governmental agencies to be an integral part of the official grain inspection system (https://www.ams.usda.gov/services/fgis/ official-grain-inspection-weighing-system). Designated agencies work under the supervision of the Federal Grain Inspection Service (FGIS) and are authorized to provide official inspection and weighing services in a defined geographic area. In addition, we request comments on the quality of services provided by the following designated agencies: Grain Inspection, Inc. (Jamestown); Lincoln Grain Inspection Service, Inc. (Lincoln); Midsouth Grain Inspection Service (Midsouth); Kansas Grain Inspection Service, Inc. (Kansas); Mid-Iowa Grain Inspection, Inc. (Mid-Iowa); Minot Grain Inspection, Inc. (Minot); Tri-State Grain Inspection, Inc. (Tri-State); Idaho Grain Inspection Service, Inc. (Idaho); Ohio Valley Grain Inspection, Inc. (Ohio Valley); California Agri Inspection Co., Ltd. (California); and Virginia Department of Agriculture and Consumer Services (Virginia). AMS encourages submissions from traditionally underrepresented individuals, organizations, and businesses to reflect the diversity of this industry. AMS encourages submissions from qualified applicants, regardless of race, color, age, sex, sexual orientation, gender identity, national origin, religion, disability status, protected veteran status, or any other characteristic protected by law. AMS is also asking for comments on the quality of official services at export port locations provided by delegated state agencies Virginia Department of Agriculture and Consumer Services (Virginia) and Wisconsin Department of Agriculture (Wisconsin). AMS considers comments and other available information when determining certification.
Proposed Collection; 60-Day Comment Request; Application Process for Clinical Research Training and Medical Education at the Clinical Center and Its Impact on Course and Training Program Enrollment and Effectiveness
Document Number: 2023-06641
Type: Notice
Date: 2023-03-30
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institutes of Health Clinical Center (CC) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Notice of Workshop on Making Data Available for National Spectrum Management
Document Number: 2023-06640
Type: Notice
Date: 2023-03-30
Agency: National Science Foundation, Agencies and Commissions
The workshop on Making Data Available for National Spectrum Management will focus on identifying challenges associated with obtaining, disseminating, and using data about spectrum to support policy making, operations, and R&D with applications to spectrum sharing & optimization through improved analysis, modeling & prediction.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2023-06639
Type: Notice
Date: 2023-03-30
Agency: Department of Health and Human Services, National Institutes of Health
Safety Zone; Gallants Channel, Beaufort, NC
Document Number: 2023-06637
Type: Proposed Rule
Date: 2023-03-30
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is proposing to establish a safety zone on the navigable waters of Gallants Channel near Beaufort, NC. The safety zone is necessary to enhance the safety of mariners and participants during the swim portion of a triathlon. Entry of vessels or persons into this safety zone is prohibited unless specifically authorized by the Captain of the Port (COTP) North Carolina or a designated representative. We invite your comments on this proposed rulemaking.
Access to Confidential Business Information by Abt Associates
Document Number: 2023-06586
Type: Notice
Date: 2023-03-30
Agency: Environmental Protection Agency
EPA has authorized its contractor Abt Associates of Rockville, MD to access information which has been submitted to EPA under all sections of the Toxic Substances Control Act (TSCA). Some of the information may be claimed or determined to be Confidential Business Information (CBI).
Certain Tool Chests and Cabinets From the People's Republic of China: Final Results of the Expedited First Sunset Review of the Countervailing Duty Order
Document Number: 2023-06585
Type: Notice
Date: 2023-03-30
Agency: Department of Commerce, International Trade Administration
As a result of this expedited sunset review, the U.S. Department of Commerce (Commerce) finds that revocation of the countervailing duty (CVD) order on certain tool chests and cabinets (tool chests and cabinets) from the People's Republic of China (China) would be likely to lead to continuation or recurrence of countervailable subsidies at the levels indicated in the ``Final Results of Sunset Review'' section of this notice.
Community Development Revolving Loan Fund Access for Credit Unions
Document Number: 2023-06584
Type: Notice
Date: 2023-03-30
Agency: National Credit Union Administration, Agencies and Commissions
The National Credit Union Administration (NCUA) is issuing this Notice of Funding Opportunity (NOFO) to announce the availability of technical assistance grants (awards) for low-income designated (LICUs) and Minority Depository Institution (MDIs) credit unions through the CDRLF. The CDRLF provides financial support in the form of loans and technical assistance grants that help credit unions support the communities in which they operate. All grant awards made under this NOFO are subject to funds availability and are at the NCUA's discretion.
Applications for New Awards; Asian American and Native American Pacific Islander-Serving Institutions Program
Document Number: 2023-06583
Type: Notice
Date: 2023-03-30
Agency: Department of Education
The Department of Education (Department) is issuing a notice inviting applications for new awards for fiscal year (FY) 2023 for the Asian American and Native American Pacific Islander-Serving Institutions (AANAPISI) Program, Assistance Listing Number 84.031L. This notice relates to the approved information collection under OMB control number 1840-0798.
Stainless Steel Sheet and Strip From the People's Republic of China: Final Scope Ruling and Final Affirmative Determination of Circumvention for Exports From the Socialist Republic of Vietnam
Document Number: 2023-06582
Type: Notice
Date: 2023-03-30
Agency: Department of Commerce, International Trade Administration
The U.S. Department of Commerce (Commerce) determines that certain stainless steel sheet and strip (SSSS) of Chinese-origin that has undergone further processing in the Socialist Republic of Vietnam (Vietnam) is merchandise covered by the scope of the antidumping duty (AD) and countervailing duty (CVD) orders on SSSS from the People's Republic of China (China). Additionally, Commerce determines that SSSS that is completed in Vietnam using certain non-subject stainless steel flat-rolled inputs sourced from China, is circumventing the AD/CVD orders on SSSS from China. As a result, SSSS of Chinese-origin that has undergone further processing or completion in Vietnam will be subject to suspension of liquidation effective May 15, 2020.
Applications for New Awards; Minority Science and Engineering Improvement Program (MSEIP)
Document Number: 2023-06581
Type: Notice
Date: 2023-03-30
Agency: Department of Education
The Department of Education (Department) is issuing a notice inviting applications for fiscal year (FY) 2023 for the MSEIP, Assistance Listing Number 84.120A. This notice relates to the approved information collection under OMB control number 1840-0109.
Determination of Regulatory Review Period for Purposes of Patent Extension; M6-C Artificial Cervical Disc
Document Number: 2023-06580
Type: Notice
Date: 2023-03-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for M6-C ARTIFICIAL CERVICAL DISC and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Filing of Color Additive Petition From Center for Science in the Public Interest, et al.; Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs; Extension of Comment Period
Document Number: 2023-06579
Type: Proposed Rule
Date: 2023-03-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the comment period for the color additive petition for which we published a notice of filing in the Federal Register of February 17, 2023. In the notice, FDA requested comments on a filed color additive petition submitted by Center for Science in the Public Interest, et al., proposing that FDA repeal the color additive regulations providing for the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Second 10-Year Maintenance Plan for the Coso Junction PM-10 Planning Area; California
Document Number: 2023-06578
Type: Proposed Rule
Date: 2023-03-30
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is proposing to approve the ``Coso Junction PM10 Planning Area Second 10- Year Maintenance Plan'' (``Coso Junction Second Maintenance Plan'' or ``Plan'') as a revision to the state implementation plan (SIP) for the State of California. The Coso Junction Second Maintenance Plan includes, among other elements, a base year emissions inventory, a maintenance demonstration, and contingency provisions. The EPA is proposing this action because the SIP revision meets the applicable statutory and regulatory requirements for such plans. The EPA is also proposing to find the contribution of motor vehicles to the area's continued attainment of the 1987 PM10 standard to be insignificant and is initiating the adequacy review process for this insignificance finding through this Notice of Proposed Rule Making (NPRM). If this insignificance finding is finalized, the area would not have to complete a regional emissions analysis for any transportation conformity determinations necessary for the Coso Junction Planning Area (CJPA).
Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2023-06577
Type: Notice
Date: 2023-03-30
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 Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System 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.
Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures
Document Number: 2023-06566
Type: Rule
Date: 2023-03-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is issuing a final rule to classify spinal spheres for use in intervertebral fusion procedures (an unclassified, preamendments device) into class III for which FDA is separately requiring the filing of a premarket approval application (PMA). FDA has determined that general controls and special controls together are insufficient to provide reasonable assurance of safety and effectiveness for this device.
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