March 16, 2022 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 79
Air Plan Approval; Pennsylvania; Allegheny County Area Fine Particulate Matter Clean Data Determination
The Environmental Protection Agency (EPA) is finalizing a determination that the Allegheny County, Pennsylvania nonattainment area has clean data for the 2012 annual fine particulate matter (PM2.5) national ambient air quality standard (NAAQS). This clean data determination (CDD) is based upon quality-assured, quality- controlled, and certified ambient air monitoring data showing the area has attained the 2012 annual PM2.5 NAAQS based on the 2018- 2020 data available in EPA's Air Quality System (AQS) database. Based on this clean data determination, pursuant to EPA's Clean Data Policy, the obligation for Pennsylvania to make submissions to meet certain Clean Air Act (CAA or the Act) attainment plan requirements for the 2012 annual PM2.5 NAAQS for the Allegheny County area is suspended for as long as the area continues to attain the 2012 annual PM2.5 NAAQS. Following this final action, Pennsylvania's remaining obligation to submit contingency measures in response to EPA's May 14, 2021 conditional approval of Allegheny County's PM2.5 attainment plan is suspended. Additionally, the federal implementation plan (FIP) clock, which was triggered by EPA's March 26, 2018 Finding of Failure to Submit an attainment plan for the 2012 PM2.5 NAAQS for the Allegheny County Nonattainment Area, is suspended for the remaining contingency measures element conditionally approved as part of EPA's May 14, 2021 action on the Allegheny County PM2.5 attainment plan.
Orders: Reporting by Regulated Entities of Stress Testing Results as of December 31, 2021; Summary Instructions and Guidance
In this document, the Federal Housing Finance Agency (FHFA) provides notice that it issued Orders, dated March 10, 2022, with respect to stress test reporting as of December 31, 2021, under section 165(i)(2) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act), as amended by section 401 of the Economic Growth, Regulatory Relief, and Consumer Protection Act (EGRRCPA). Summary Instructions and Guidance accompanied the Orders to provide testing scenarios.
National Priorities List
The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (``CERCLA'' or ``the Act''), as amended, requires that the National Oil and Hazardous Substances Pollution Contingency Plan (``NCP'') include a list of national priorities among the known releases or threatened releases of hazardous substances, pollutants or contaminants throughout the United States. The National Priorities List (``NPL'') constitutes this list. The NPL is intended primarily to guide the Environmental Protection Agency (``the EPA'' or ``the agency'') in determining which sites warrant further investigation. These further investigations will allow the EPA to assess the nature and extent of public health and environmental risks associated with the site and to determine what CERCLA-financed remedial action(s), if any, may be appropriate. This rule adds 12 sites to the NPL, 11 to the General Superfund section and one to the Federal Facilities section.
Air Plan Approval; GA; Updates to References to Appendix W Modeling Guidelines
The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of Georgia, through the Georgia Environmental Protection Division (GA EPD) on September 1, 2020. Specifically, EPA is proposing to approve updates to the incorporation by reference of federal prevention of significant deterioration (PSD) new source review (NSR) regulations in the Georgia SIP. Based on the proposal to approve this SIP revision, EPA is also proposing to convert the previous conditional approval regarding Georgia's infrastructure SIP's PSD elements for the 2015 Ozone National Ambient Air Quality Standard (NAAQS) to a full approval. EPA is proposing to approve these changes pursuant to the Clean Air Act (CAA or Act).
Notice of Public Meeting of the Virginia Advisory Committee; Correction
The Commission on Civil Rights published a notice in the Federal Register on Friday, March 4, 2022, concerning a briefing of the Virginia Advisory Committee. The document contained the incorrect meeting access code.
Approval of Arizona Air Plan Revisions, Arizona Department of Environmental Quality and Maricopa County Air Quality Department
The Environmental Protection Agency (EPA) is taking final action to approve revisions to the Arizona Department of Environmental Quality (ADEQ) and Maricopa County Air Quality Department (MCAQD) portions of the Arizona State Implementation Plan (SIP). These revisions were submitted by ADEQ and MCAQD in response to the EPA's June 12, 2015 finding of substantial inadequacy and SIP call for certain provisions in the SIP related to excess emissions during startup, shutdown, and malfunction (SSM) events. The EPA is finalizing approval of the SIP revisions because the Agency has determined that they are in accordance with the requirements for SIP provisions under the Clean Air Act (CAA or the Act) and correct deficiencies identified in the June 12, 2015 SIP call.
Notice of the Text of the Proposed Amendments to the National Market System Plan Governing the Consolidated Audit Trail for Purposes of Short Sale-Related Data Collection
The Securities and Exchange Commission (``Commission'') is publishing notice of the text of the proposed amendments to the National Market System Plan Governing the Consolidated Audit Trail (``CAT NMS Plan'') in connection with the Commission's issuance of Release No. 34-94313, the ``Short Position and Short Activity Reporting by Institutional Investment Managers'' (the ``Proposing Release'').
Short Position and Short Activity Reporting by Institutional Investment Managers
The Securities and Exchange Commission (the ``Commission'') is proposing a new rule and related form pursuant to the Securities Exchange Act of 1934 (the ``Exchange Act''), including Section 13(f)(2), which was added by Section 929X of the Dodd-Frank Wall Street Reform and Consumer Protection Act (``DFA''). The proposed rule and related form are designed to provide greater transparency through the publication of short sale related data to investors and other market participants. Under the rule, institutional investment managers that meet or exceed a specified reporting threshold would be required to report, on a monthly basis using the proposed form, specified short position data and short activity data for equity securities. In addition, the Commission is proposing a new rule under the Exchange Act to prescribe a new ``buy to cover'' order marking requirement, and proposing to amend the national market system plan governing the consolidated audit trail (``CAT'') created pursuant to the Exchange Act to require the reporting of ``buy to cover'' order marking information and reliance on the bona fide market making exception in the Commission's short sale rules. The Commission is publishing the text of the proposed amendments to the CAT NMS Plan in a separate notice.
Enterprise Regulatory Capital Framework-Prescribed Leverage Buffer Amount and Credit Risk Transfer
The Federal Housing Finance Agency (FHFA or the Agency) is adopting a final rule (final rule) that amends the Enterprise Regulatory Capital Framework (ERCF) by refining the prescribed leverage buffer amount (PLBA or leverage buffer) and credit risk transfer (CRT) securitization framework for the Federal National Mortgage Association (Fannie Mae) and the Federal Home Loan Mortgage Corporation (Freddie Mac, and with Fannie Mae, each an Enterprise). The final rule also makes technical corrections to various provisions of the ERCF that was published on December 17, 2020.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Meat and Poultry Products Industry Data Collection
The Environmental Protection Agency has submitted an information collection request (ICR), ``Meat and Poultry Products Industry Data Collection'' (EPA ICR No. 2701.01, OMB Control No. 2040- NEW) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a request for approval of a new collection. Public comments were previously requested via the Federal Register on November 19, 2021, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may not conduct or sponsor and a person is not required to respond to a collection of information addressed to ten or more entities unless it displays a currently valid OMB control number.
CERCLA Cashout Settlement Agreement for the C-Brite Removal Site in Harbor City; Los Angeles County, California
In accordance with the Comprehensive Environmental Response, Compensation and Liability Act of 1980, as amended (``CERCLA''), notice is hereby given that the Environmental Protection Agency (EPA), has entered into a proposed settlement, embodied in a Cashout Settlement Agreement for Ability to Pay Peripheral Parties (``Settlement Agreement''), with the Laffey Family Trust, dated August 6, 2001 (and amended January 24, 2013), and Virginia Laffey (collectively, ``Settling Parties''), owners of the real property located at 1213 253rd Street, Harbor City, Los Angeles County, California, known as the Former C- Brite Metal Finishing Facility Site (``C-Brite Site'' or ``Site''). C- Brite Metal Finishing, Inc. operated a plating business at the Site from 1966 to 2017 and abandoned the property thereafter. Under the Settlement Agreement, the Settling Parties' CERCLA liability will be resolved in exchange for a lump sum payment of $100,000, which will be placed in a special account and used to fund response actions at the Site.
Notice of Proposed Administrative Settlement Agreement for Removal Action and Payment of Response Costs by Prospective Lessee at theC-Brite Removal Site in Harbor City; Los Angeles County, California
In accordance with the Comprehensive Environmental Response, Compensation and Liability Act of 1980, as amended (``CERCLA''), notice is hereby given that the Environmental Protection Agency (EPA), has entered into a proposed settlement, embodied in an Administrative Settlement Agreement for Removal Action and Payment of Response Costs by Prospective Lessee (``Settlement Agreement''), with 1213 253rd, LLC (``Prospective Lessee''), a prospective lessee and purchaser of the real property located at 1213 253rd Street, Harbor City, Los Angeles County, California, known as the Former C-Brite Metal Finishing Facility Site (``C-Brite Site'' or ``Site''). C-Brite Metal Finishing, Inc. operated a plating business at the Site from 1966 to 2017 and abandoned the property thereafter. Under the Settlement Agreement, the Prospective Lessee agrees to perform a portion of the removal work at the Site and to pay $80,000 for EPA's oversight costs in exchange for liability protection, contribution protection, a release of any lien on the Site under CERCLA Section 107(r) or 107(l), and a covenant not to sue for existing contamination at the Site, the payment of EPA's oversight costs, or the removal work. EPA completed the removal of hazardous contamination at the site, and the Lessee will now continue with the removal of all the remaining non-hazardous debris.
Airworthiness Directives; Goodrich Externally-Mounted Hoist Assemblies
The FAA is adopting a new airworthiness directive (AD) for various model helicopters with certain part-numbered Goodrich externally-mounted hoist assemblies (hoists) installed. This AD was prompted by hoists failing lower load limit inspections. This AD requires replacing unmodified hoists, installing placards, revising the existing Rotorcraft Flight Manual (RFM) for your helicopter, deactivating or removing a hoist if a partial peel out occurs, reviewing the helicopter's hoist slip load test records, repetitively inspecting the hoist cable and overload clutch (clutch), and reporting information to the manufacturer. This AD also requires establishing operating limitations on the hoist and prohibits installing an unmodified hoist. The FAA is issuing this AD to address the unsafe condition on these products.
Proposed Settlement Agreement, Clean Air Act Citizen Suit
In accordance with the Clean Air Act, as amended (CAA or the Act), notice is given of a proposed settlement agreement in Genscape, Inc. v. EPA, No. 19-3705 (6th Cir.). On July 26, 2019, Petitioner Genscape, Inc. (Genscape) filed a petition for review in the United States Court of Appeals for the Sixth Circuit. Genscape challenged the final action of the Environmental Protection Agency (EPA or the Agency) entitled ``EPA Final Determination in the Matter of Genscape, Inc., Option A Quality Assurance Plan Auditor Under the Renewable Fuel Standard Program'' (``Final Determination''), which was issued on May 31, 2019. The proposed settlement agreement would require dismissal of the litigation once EPA issues a revision to the Final Determination as specified in Attachment A.
CBP Hiring Center Medical Records Release Privacy Act Form
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.
Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Ocean Wind Marine Site Characterization Surveys, New Jersey
NMFS has received a request from Ocean Wind, LLC (Ocean Wind) for authorization to take marine mammals incidental to marine site characterization surveys in the area of Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf Lease Area OCS-A 0532 and potential export cable routes to landfall locations in New Jersey. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an incidental harassment authorization (IHA) to incidentally take marine mammals during the specified activities. NMFS is also requesting comments on a possible one-year renewal that could be issued under certain circumstances and if all requirements are met, as described in Request for Public Comments at the end of this notice. NMFS will consider public comments prior to making any final decision on the issuance of the requested MMPA authorizations and agency responses will be summarized in the final notice of our decision.
Medicaid Program; Final FY 2018, Final FY 2019, Preliminary FY 2020, and Preliminary FY 2021 Disproportionate Share Hospital Allotments, and Final FY 2018, Final FY 2019, Preliminary FY 2020, and Preliminary FY 2021 Institutions for Mental Diseases Disproportionate Share Hospital Limits
This notice announces the final Federal share (FS) disproportionate share hospital (DSH) allotments for Federal fiscal year (FY) 2018 and FY 2019, and the preliminary FS DSH allotments for FY 2020 and FY 2021. This notice also announces the final FY 2018 and FY 2019 and the preliminary FY 2020 and FY 2021 limitations on aggregate DSH payments that States may make to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of States' FY DSH allotments.
Asylum Interview Interpreter Requirement Modification Due to COVID-19
The Department of Homeland Security (DHS) is extending, for a third time, the effective date (for 365 days) of its temporary final rule that modified certain regulatory requirements to help ensure that USCIS may continue with affirmative asylum adjudications during the COVID-19 pandemic.
Imposition of Sanctions on `Luxury Goods' Destined for Russia and Belarus and for Russian and Belarusian Oligarchs and Malign Actors Under the Export Administration Regulations (EAR)
In response to the Russian Federation's (Russia's) further invasion of Ukraine, and Belarus's substantial enabling of Russia's invasion, the Department of Commerce is imposing restrictions on the export, reexport, or transfer (in-country) to or within Russia or Belarus of `luxury goods' under the Export Administration Regulations (EAR) and for exports, reexports and transfers (in-country) worldwide to certain Russian or Belarusian oligarchs and other malign actors supporting the Russian or Belarusian governments. Taken together, these new export controls will significantly limit financially elite individuals' and organizations' access to luxury goods and thereby accentuate the consequences of providing such support.
Airworthiness Directives; The Boeing Company Airplanes
The FAA is adopting a new airworthiness directive (AD) for all The Boeing Company Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400, 747-400D, and 747-400F series airplanes. This AD was prompted by a determination that radio altimeters cannot be relied upon to perform their intended function if they experience interference from wireless broadband operations in the 3.7-3.98 GHz frequency band (5G C-Band), and a recent determination that during takeoff, approach, landings, and go-arounds, as a result of this interference, certain airplane systems may not properly function, resulting in increased flightcrew workload while on approach with the flight director, autothrottle, or autopilot engaged, which could result in reduced ability of the flightcrew to maintain safe flight and landing of the airplane. This AD requires revising the limitations and operating procedures sections of the existing airplane flight manual (AFM) to incorporate specific operating procedures for takeoff, instrument landing system (ILS) approaches, non-precision approaches, and go-around and missed approaches, when in the presence of 5G C-Band interference as identified by Notices to Air Missions (NOTAMs). The FAA is issuing this AD to address the unsafe condition on these products.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Petitions for Exemption From the Vehicle Theft Prevention Standard
In compliance with the Paperwork Reduction Act of 1995 (PRA), this notice announces that the Information Collection Request (ICR) summarized below has been forwarded to the Office of Management and Budget (OMB) for review and approval. The ICR describes the nature of the information collections and their expected burden. The Federal Register Notice with a 60-day comment period for approval of a reinstatement of this previously approved information collection was published on August 20, 2020. The agency received no comments.
EAC Federal Financial Report; Survey and Submission to OMB of Proposed Collection of Information
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the U.S. Election Assistance Commission (EAC) gives notice that it is requesting from the Office of Management and Budget (OMB) approval for the information collection EAC Federal Financial Report (EAC-FFR).
Petition for Exemption From the Federal Motor Vehicle Theft Prevention Standard; Volkswagen Group of America, Inc.
This document grants in full the Volkswagen Group of America, Inc.'s (Volkswagen) petition for exemption from the Federal Motor Vehicle Theft Prevention Standard (theft prevention standard) for its Audi e-tron GT vehicle line beginning in model year (MY) 2023. The petition is granted because the agency has determined that the antitheft device to be placed on the line as standard equipment is likely to be as effective in reducing and deterring motor vehicle theft as compliance with the parts-marking requirements of the theft prevention standard. Volkswagen also requested confidential treatment for specific information in its petition. Therefore, no confidential information provided for purposes of this notice has been disclosed.
Carbon Capture, Utilization, and Sequestration Guidance
On February 16, 2022, the Council on Environmental Quality (CEQ) published a notice announcing the availability of and seeking comment on an interim guidance document, ``Carbon Capture, Utilization, and Sequestration Guidance.'' CEQ is extending the comment period on the notice, which was scheduled to close on March 18, 2022, for 31 days until April 18, 2022.
Certain Automated Storage and Retrieval Systems, Robots, and Components Thereof; Notice of a Commission Determination To Review in Part a Final Initial Determination and Order No. 33; and, on Review, To Find No Violation of Section 337 Termination of the Investigation
Notice is hereby given that the U.S. International Trade Commission has determined to review in part the presiding administrative law judge's (``ALJ'') final initial determination (``ID'') issued on December 13, 2021, finding no violation of section 337, and Order No. 33 (``Markman Order''), issued on July 22, 2021, in the above-referenced investigation. On review, the Commission has determined to find no violation of section 337. The investigation is terminated in its entirety.
Privacy Act of 1974; System of Records
We propose to revise a system of records in our existing inventory of systems subject to the Privacy Act of 1974. The system is NARA 1, Researcher Application Files. We are adding a new purpose/ routine use to notify researchers who use our facilities if they might have been exposed to COVID-19 while at our facility, to allow for similar notifications in the event of future public health emergencies, and to allow notification of health departments for collaborative efforts to address exposure and meet reporting requirements. We are also updating the SORN to reorganize the SORN into the current required format. In this notice, we publish the system of records notice in full for public notice and comment.
Updates to Telephone and Facsimile Numbers
This document amends the Equal Employment Opportunity Commission's regulations by updating a telephone number and a facsimile number.
60-Day Notice of Proposed Information Collection: Rural Capacity Building
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 60 days of public comment.
Airworthiness Directives; Airbus Helicopters Deutschland GmbH Helicopters
The FAA is adopting a new airworthiness directive (AD) for all Airbus Helicopters Deutschland GmbH Model MBB-BK 117 D-3 helicopters. This AD was prompted by reports of a main rotor (M/R) blade lead-lag damper in a tilted position. This AD requires inspecting the Flex Control Unit (FCU), and corrective actions if necessary, as well as rework and re-identification of the bearing pin, as specified in a European Union Aviation Safety Agency (EASA) AD, which is incorporated by reference. The FAA is issuing this AD to address the unsafe condition on these products.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Consumer Price Index Housing Survey
The Department of Labor (DOL) is submitting this Bureau of Labor Statistics (BLS)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Abandoned Individual Account Plan Termination
The Department of Labor (DOL) is submitting this Employee Benefits Security Administration (EBSA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Voluntary Fiduciary Correction Program
The Department of Labor (DOL) is submitting this Employee Benefits Security Administration (EBSA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
Notice of Public Meeting of the Arizona Advisory Committee
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 (FACA) that the Arizona Advisory Committee (Committee) to the Commission will hold a meeting via Webex on Friday, March 25, 2022, from 11:00 a.m. to 12:00 p.m. Mountain Standard Time, for the purpose of discussing potential civil rights topics to study.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Evaluation of the Implementation of the Statewide Family Engagement Centers
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a new information collection.
Enhanced Transparency and Access to Information for Debtors and Sureties in the Automated Commercial Environment
This document announces that U.S. Customs and Border Protection (CBP) is making three enhancements to CBP's debt management processes to increase transparency and access to information for debtors and sureties. One of the enhancements will support importers of record, licensed customs brokers, and other Automated Commercial Environment (ACE) account users who owe debts to CBP by enabling the electronic viewing of bill sanction status and protest details in the unpaid, open bill details report in ACE. The other two enhancements will facilitate compliance for sureties by providing electronic access to the monthly report listing open delinquent bills by importer name (i.e., the Formal Demand on Surety for Payment of Delinquent Amounts Due, also informally referred to as the 612 Report) in ACE (in lieu of CBP emailing this information to sureties) and improving the content and design of the mailed 612 Report.
Special Local Regulation; 2022 Horsepower on the Hudson, Hudson River, Castleton, NY
The Coast Guard is proposing to establish temporary special local regulations on certain waters of the Hudson River in the vicinity of Castleton-on-the-Hudson, New York, in support of the Horsepower on the Hudson event on August 8, 2022. This action is necessary to ensure the safety of participants, participant vessels, spectators, and mariners transiting the area from the dangers associated with vessels operating at high-speeds during the Horsepower on the Hudson event. This proposed rulemaking would allow the Coast Guard to enforce vessel movements within three regulated areas and temporarily restrict vessel traffic in a portion of the Hudson River between Hudson River Lighted Buoy 202 (LLNR 38905) to Hudson River Light 204 (LLNR 38910). We invite your comments on this proposed rulemaking.
Privacy Act of 1974; System of Records
To fulfill its conflict resolution and training mission, Federal Mediation and Conciliation Service (FMCS) uses Microsoft SharePoint, Microsoft Outlook, and a case records management system new to FMCS to enable mediators and managers to manage cases, manage reporting requirements, provide data for research and training, store recorded trainings and meetings, and collect information on Agency operations. The Agency's internal drives, SharePoint, Outlook, Cloud- based services such as Zoom.gov and Microsoft Teams, and a case records management system are used to store electronic case tracking information, electronic case files (including mediation agreements), and recorded meetings and trainings, permitting the accurate and timely collection, retrieval, and retention of information maintained by offices of the Agency. Inter-Agency Agreements (IAA), agreements for reimbursable services, and requests for mediation and training are also stored in these locations. IAAs and agreements for reimbursable services allow FMCS to provide requested services, such as training and labor dispute resolution, to other federal agencies. The notice amendment includes administrative updates to refine details published under summary, dates, supplementary information, system name, system location, authority for maintenance of the system, purpose of the system, categories of individuals covered by the system, categories of records in the system, record source categories, routine uses, policies and practices for storage of records, policies and practices for retrieval of records, policies and practices for retention and disposal of records, administrative safeguards, record access procedures, and contesting records procedures. These sections are amended to refine previously published information about the system of records. The addresses, for further information contact, security classification, system location, system manager, notification procedures, exemptions promulgated, and history remain unchanged. This amended SORN deletes and supersedes the SORN published in the Federal Register on September 21, 2021.
Notice of Stakeholder Surveys for Facilitation and Other Purposes
FMCS invites the general public and other Federal Agencies to take this opportunity to comment on the surveys and other information FMCS will collect to inform the process and participants for its conflict prevention, management, and resolution services provided to Federal Agencies, particularly public policy mediations and facilitations that include participants external to the federal government.
Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2022
The Food and Drug Administration (FDA or the Agency) is announcing the fee rates under the over-the-counter (OTC) monograph drug user fee program (OMUFA) for fiscal year (FY) 2022. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests. This notice publishes the OMUFA fee rates for FY 2022.
Considerations for the Development of Chimeric Antigen Receptor T Cell Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Considerations for the Development of Chimeric Antigen Receptor T Cell Products; Draft Guidance for Industry.'' The draft guidance document is intended to assist sponsors, including industry and academic sponsors, developing Chimeric Antigen Receptor (CAR) T cell products. The draft guidance includes CAR T cell-specific recommendations regarding chemistry, manufacturing, and control (CMC), pharmacology and toxicology, and clinical study design.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Accessories
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on medical device accessory requests.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.