November 29, 2023 – Federal Register Recent Federal Regulation Documents

Negotiated Rulemaking Committee; Negotiator Nominations and Schedule of Committee Meetings
Document Number: 2023-26198
Type: Proposed Rule
Date: 2023-11-29
Agency: Department of Education
We announce our intention to establish a negotiated rulemaking committee to prepare proposed regulations for Federal programs authorized under title IV of the Higher Education Act of 1965, as amended (HEA). The committee will include representatives of organizations or groups with interests that are significantly affected by the subject matter of the proposed regulations. We request nominations for individual negotiators who represent key stakeholder constituencies for the issues to be negotiated to serve on the committee. We also announce the creation of a subcommittee, and request nominations for individuals with pertinent expertise to participate on the subcommittee. The Department has also set a schedule for committee meetings.
Cost of Living Adjustment to Satellite Carrier Compulsory License Royalty Rates
Document Number: 2023-26122
Type: Rule
Date: 2023-11-29
Agency: Copyright Royalty Board, Library of Congress, Library of Congress, Agencies and Commissions
The Copyright Royalty Judges announce a cost of living adjustment (COLA) of 3.2% in the royalty rates satellite carriers pay for a compulsory license under the Copyright Act. The COLA is based on the change in the Consumer Price Index from October 2022 to October 2023.
National Bioengineered Food Disclosure Standard; List of Bioengineered Foods
Document Number: 2023-26059
Type: Rule
Date: 2023-11-29
Agency: Agricultural Marketing Service, Department of Agriculture
This final rule updates the National Bioengineered Food Disclosure Standard's (the Standard) List of Bioengineered (BE) Foods (the List) by adding ``sugarcane (Bt insect-resistant varieties)'' to the List and amending ``squash (summer)'' to ``squash (summer, coat protein-mediated virus-resistant varieties).'' In updating the List, this final rule provides consumers with information regarding foods that may be BE and aids regulated entities in determining whether they need to make a BE disclosure.
Magnuson-Stevens Act Provisions; Fisheries Off West Coast States; Pacific Coast Groundfish Fishery; 2023-2024 Biennial Specifications and Management Measures; Inseason Adjustments
Document Number: 2023-26018
Type: Rule
Date: 2023-11-29
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
This final rule announces routine inseason adjustments to management measures in commercial and recreational groundfish fisheries for the 2024 fishing year. This action is intended to allow commercial and recreational fishing vessels to access more abundant groundfish stocks while protecting overfished and depleted stocks.
Energy Conservation Program: Energy Conservation Standards for Oil, Electric, and Weatherized Gas Consumer Furnaces
Document Number: 2023-25869
Type: Proposed Rule
Date: 2023-11-29
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 non- weatherized oil-fired furnaces (``NWOFs''), mobile home oil-fired furnaces (``MHOFs''), weatherized gas furnaces (``WGFs''), weatherized oil-fired furnaces (``WOFs''), and electric furnaces (``EFs''). EPCA also requires the U.S. Department of Energy (``DOE'') to periodically review its existing standards to determine whether more-stringent, amended standards would be technologically feasible and economically justified, and would result in significant energy savings. In this notification of proposed determination (``NOPD''), DOE has initially determined that amended energy conservation standards for EFs, NWOFs, MHOFs, WOFs, and WGFs do not need to be amended. DOE requests comment on this proposed determination and the associated analyses and results.
Special Assessment Pursuant to Systemic Risk Determination
Document Number: 2023-25813
Type: Rule
Date: 2023-11-29
Agency: Federal Deposit Insurance Corporation, Agencies and Commissions
The FDIC is adopting a final rule to implement a special assessment to recover the loss to the Deposit Insurance Fund (DIF or Fund) arising from the protection of uninsured depositors following the closures of Silicon Valley Bank, Santa Clara, CA, and Signature Bank, New York, NY. The FDIC will collect the $16.3 billion special assessment at a quarterly rate of 3.36 basis points, multiplied by an insured depository institution's (IDI) estimated uninsured deposits, reported for the quarter that ended December 31, 2022, adjusted to exclude the first $5 billion in estimated uninsured deposits from the IDI, or for IDIs that are part of a holding company with one or more subsidiary IDIs, at the banking organization level. The FDIC will collect the special assessment over eight quarterly assessment periods, although the collection period may change due to updates to the estimated loss pursuant to the systemic risk determination or if assessments collected change due to corrective amendments to the amount of uninsured deposits reported for the December 31, 2022, reporting period.
Endangered and Threatened Wildlife and Plants; Seven Species Not Warranted for Listing as Endangered or Threatened Species
Document Number: 2023-25586
Type: Proposed Rule
Date: 2023-11-29
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service (Service), announce findings that seven species are not warranted for listing as endangered or threatened species under the Endangered Species Act of 1973, as amended (Act). After a thorough review of the best available scientific and commercial information, we find that it is not warranted at this time to list Edison's ascyrum (Hypericum edisonianum), Florida (lowland) loosestrife (Lythrum flagellare), Florida pinesnake (Pituophis melanoleucus mugitu), mimic cavesnail (Phreatodrobia imitata), northern cavefish (Amblyopsis spelaea), smallscale darter (Etheostoma microlepidum), and Texas troglobitic water slater (Lirceolus smithii). However, we ask the public to submit to us at any time any new information relevant to the status of any of the species mentioned above or their habitats.
Consumer Leasing (Regulation M)
Document Number: 2023-25049
Type: Rule
Date: 2023-11-29
Agency: Federal Reserve System, Agencies and Commissions
The Board and the Bureau (collectively, the Agencies) are finalizing amendments to the official interpretations and commentary for the Agencies' regulations that implement the Consumer Leasing Act (CLA). The Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) amended the CLA by requiring that the dollar threshold for exempt consumer leases be adjusted annually by the annual percentage increase in the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W). Under regulations adopted by the Agencies, if there is no annual percentage increase in the CPI-W, the Agencies will not adjust this exemption threshold from the prior year. Additionally, in years following a year in which the exemption threshold was not adjusted because the CPI-W decreased, the threshold is calculated by applying the annual percentage change in the CPI-W to the dollar amount that would have resulted, after rounding, if the decreases and any subsequent increases in the CPI-W had been taken into account. Based on the annual percentage increase in the CPI-W as of June 1, 2023, the exemption threshold will increase from $66,400 to $69,500 effective January 1, 2024. Because the Dodd-Frank Act also requires similar adjustments in the Truth in Lending Act's threshold for exempt consumer credit transactions, the Agencies are making similar amendments to each of their respective regulations implementing the Truth in Lending Act elsewhere in the Rules section of this issue of the Federal Register.
Truth in Lending (Regulation Z)
Document Number: 2023-25048
Type: Rule
Date: 2023-11-29
Agency: Federal Reserve System, Agencies and Commissions
The Board and the Bureau (collectively, the Agencies) are publishing final rules amending the official interpretations and commentary for the Agencies' regulations that implement the Truth in Lending Act (TILA). The Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) amended TILA by requiring that the dollar threshold for exempt consumer credit transactions be adjusted annually by the annual percentage increase in the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W). Under regulations adopted by the Agencies, if there is no annual percentage increase in the CPI-W, the Agencies will not adjust this exemption threshold from the prior year. Additionally, in years following a year in which the exemption threshold was not adjusted because the CPI-W decreased, the threshold is calculated by applying the annual percentage change in the CPI-W to the dollar amount that would have resulted, after rounding, if the decreases and any subsequent increases in the CPI-W had been taken into account. Based on the annual percentage increase in the CPI-W as of June 1, 2023, the exemption threshold will increase from $66,400 to $69,500 effective January 1, 2024. Because the Dodd-Frank Act also requires similar adjustments in the Consumer Leasing Act's threshold for exempt consumer leases, the Agencies are making similar amendments to each of their respective regulations implementing the Consumer Leasing Act elsewhere in the Rules section of this issue of the Federal Register.
Appraisals for Higher-Priced Mortgage Loans Exemption Threshold
Document Number: 2023-25047
Type: Rule
Date: 2023-11-29
Agency: Federal Reserve System, Agencies and Commissions, Office of the Comptroller of the Currency, Department of Treasury, Department of the Treasury
The OCC, the Board, and the Bureau are finalizing amendments to the official interpretations for their regulations that implement section 129H of the Truth in Lending Act (TILA). Section 129H of TILA establishes special appraisal requirements for ``higher-risk mortgages,'' termed ``higher-priced mortgage loans'' or ``HPMLs'' in the agencies' regulations. The OCC, the Board, the Bureau, the Federal Deposit Insurance Corporation (FDIC), the National Credit Union Administration (NCUA), and the Federal Housing Finance Agency (FHFA) (collectively, the Agencies) jointly issued final rules implementing these requirements, effective January 18, 2014. The Agencies' rules exempted, among other loan types, transactions of $25,000 or less, and required that this loan amount be adjusted annually based on any annual percentage increase in the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W). If there is no annual percentage increase in the CPI-W, the OCC, the Board, and the Bureau will not adjust this exemption threshold from the prior year. Additionally, in years following a year in which the exemption threshold was not adjusted because the CPI-W decreased, the threshold is calculated by applying the annual percentage increase in the CPI-W to the dollar amount that would have resulted, after rounding, if the decreases and any subsequent increases in the CPI-W had been taken into account. Based on the CPI-W in effect as of June 1, 2023, the exemption threshold will increase from $31,000 to $32,400, effective January 1, 2024.
Boltless Steel Shelving Units Prepackaged for Sale From the Socialist Republic of Vietnam: Preliminary Affirmative Determination of Sales at Less Than Fair Value, Postponement of Final Determination, and Extension of Provisional Measures
Document Number: 2023-26231
Type: Notice
Date: 2023-11-29
Agency: Department of Commerce, International Trade Administration
The U.S. Department of Commerce (Commerce) preliminarily determines that boltless steel shelving units prepackaged for sale (boltless steel shelving) from the Socialist Republic of Vietnam (Vietnam) are being, or are likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is October 1, 2022, through March 31, 2023. Interested parties are invited to comment on this preliminary determination.
Boltless Steel Shelving Units Prepackaged for Sale From Thailand: Preliminary Affirmative Determination of Sales at Less Than Fair Value, Postponement of Final Determination, and Extension of Provisional Measures
Document Number: 2023-26230
Type: Notice
Date: 2023-11-29
Agency: Department of Commerce, International Trade Administration
The U.S. Department of Commerce (Commerce) preliminarily determines that boltless steel shelving units prepackaged for sale (boltless steel shelving) from Thailand are being, or are likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is April 1, 2022, through March 31, 2023. Interested parties are invited to comment on this preliminary determination.
Boltless Steel Shelving Units Prepackaged for Sale From Taiwan: Preliminary Affirmative Determination of Sales at Less Than Fair Value, Postponement of Final Determination, and Extension of Provisional Measures
Document Number: 2023-26229
Type: Notice
Date: 2023-11-29
Agency: Department of Commerce, International Trade Administration
The U.S. Department of Commerce (Commerce) preliminarily determines that boltless steel shelving units prepackaged for sale (boltless steel shelving) from Taiwan are being, or are likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is April 1, 2022, through March 31, 2023. Interested parties are invited to comment on this preliminary determination.
Addition of Bolivia to the List of Regions Affected With Highly Pathogenic Avian Influenza
Document Number: 2023-26228
Type: Notice
Date: 2023-11-29
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
We are advising the public that we added Bolivia to the list of regions that the Animal and Plant Health Inspection Service considers to be affected with highly pathogenic avian influenza (HPAI). This action follows our imposition of HPAI-related restrictions on the importation of avian commodities originating from or transiting Bolivia as a result of the confirmation of HPAI in that country.
Thermal Paper From the Republic of Korea: Preliminary Results of Antidumping Duty Administrative Review; 2021-2022
Document Number: 2023-26227
Type: Notice
Date: 2023-11-29
Agency: Department of Commerce, International Trade Administration
The U.S. Department of Commerce (Commerce) preliminarily determines that the sole producer/exporter subject to this administrative review made sales of subject merchandise at less than normal value (NV) during the period of review (POR) May 12, 2022, through October 31, 2023. Interested parties are invited to comment on these preliminary results.
Notice of Availability and Extension of Comment Period for the Preliminary Designation of Certain Stormwater Discharges Within Two Watersheds in Los Angeles County, California Under the National Pollutant Discharge Elimination System of the Clean Water Act
Document Number: 2023-26226
Type: Notice
Date: 2023-11-29
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) Region 9 published a document in the Federal Register on November 2, 2023, soliciting comment on the preliminary designation of stormwater discharges from certain commercial, industrial, and institutional (CII) sites in two watersheds in Los Angeles County, California for regulation under the Clean Water Act (CWA) National Pollutant Discharge Elimination System (NPDES) permitting program. The November 2, 2023 notice of availability contained an incorrect email address for submitting comments which is corrected below and the review and comment period is extended to provide a 60-day public comment period. All other information in the November 2, 2023 notice of availability is correct.
Submission for OMB Review; Comment Request
Document Number: 2023-26219
Type: Notice
Date: 2023-11-29
Agency: Department of Agriculture
Federal Reserve Bank Capital Stock
Document Number: 2023-26213
Type: Rule
Date: 2023-11-29
Agency: Federal Reserve System, Agencies and Commissions
The Board of Governors (Board) is publishing a final rule that applies an inflation adjustment to the threshold for total consolidated assets in Regulation I. Federal Reserve Bank (Reserve Bank) stockholders that have total consolidated assets above the threshold receive a different dividend rate on their Reserve Bank stock than stockholders with total consolidated assets at or below the threshold. The Federal Reserve Act requires that the Board annually adjust the total consolidated asset threshold to reflect the change in the Gross Domestic Product Price Index, published by the Bureau of Economic Analysis (BEA). Based on the change in the Gross Domestic Product Price Index as of September 28, 2023, the total consolidated asset threshold will be $12,517,000,000 through December 31, 2024.
Reserve Requirements of Depository Institutions
Document Number: 2023-26212
Type: Rule
Date: 2023-11-29
Agency: Federal Reserve System, Agencies and Commissions
The Board is amending Regulation D, Reserve Requirements of Depository Institutions, to reflect the annual indexing of the reserve requirement exemption amount and the low reserve tranche for 2024. The annual indexation of these amounts is required notwithstanding the Board's action in March 2020 of setting all reserve requirement ratios to zero. The reserve requirement exemption amount for 2023 will remain $36.1 million, unchanged for 2024, consistent with the Federal Reserve Act (the ``Act''). The Board is amending Regulation D to set the amount of the low reserve tranche at $644.0 million (decreased from $691.7 million in 2023). The adjustment to the low reserve tranche is derived using a statutory formula specified in the Act. The annual indexation of the reserve requirement exemption amount and low reserve tranche is required by statute but will not affect depository institutions' reserve requirements, which will remain zero.
Long-Term Debt Requirements for Large Bank Holding Companies, Certain Intermediate Holding Companies of Foreign Banking Organizations, and Large Insured Depository Institutions; Extension of Comment Period
Document Number: 2023-26202
Type: Proposed Rule
Date: 2023-11-29
Agency: Federal Deposit Insurance Corporation, Agencies and Commissions, Federal Reserve System, Office of the Comptroller of the Currency, Department of Treasury, Department of the Treasury
On September 19, 2023, the Board of Governors of the Federal Reserve System (Board), the Federal Deposit Insurance Corporation (FDIC), and the Office of the Comptroller of the Currency (OCC) (collectively, the ``agencies'') published in the Federal Register a proposal to require certain large depository institution holding companies, U.S. intermediate holding companies of foreign banking organizations, and insured depository institutions, to issue and maintain outstanding a minimum amount of long-term debt. The agencies have determined that an extension of the comment period until January 16, 2024, is appropriate.
Determination of Regulatory Review Period for Purposes of Patent Extension; Kerendia
Document Number: 2023-26251
Type: Notice
Date: 2023-11-29
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 Kerendia and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption
Document Number: 2023-26250
Type: Notice
Date: 2023-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Rural Health Network Development Program Performance Improvement Measurement System, OMB No. 0906-0010-Revision
Document Number: 2023-26249
Type: Notice
Date: 2023-11-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Evidence Based Telehealth Network Program Measures
Document Number: 2023-26248
Type: Notice
Date: 2023-11-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Determination of Regulatory Review Period for Purposes of Patent Extension; Lupkynis
Document Number: 2023-26247
Type: Notice
Date: 2023-11-29
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 Lupkynis and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; Azstarys
Document Number: 2023-26246
Type: Notice
Date: 2023-11-29
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 Azstarys and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Combined Notice of Filings #1
Document Number: 2023-26245
Type: Notice
Date: 2023-11-29
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings
Document Number: 2023-26244
Type: Notice
Date: 2023-11-29
Agency: Department of Energy, Federal Energy Regulatory Commission
Georgia Power Company; Notice of Availability of Environmental Assessment
Document Number: 2023-26240
Type: Notice
Date: 2023-11-29
Agency: Department of Energy, Federal Energy Regulatory Commission
Records Governing Off-the-Record Communications; Public Notice
Document Number: 2023-26239
Type: Notice
Date: 2023-11-29
Agency: Department of Energy, Federal Energy Regulatory Commission
Allocation of Assets in Single-Employer Plans; Valuation of Benefits and Assets; Expected Retirement Age
Document Number: 2023-26238
Type: Rule
Date: 2023-11-29
Agency: Pension Benefit Guaranty Corporation, Agencies and Commissions
This rule amends the Pension Benefit Guaranty Corporation's regulation on Allocation of Assets in Single-Employer Plans by substituting a new table for determining expected retirement ages for participants in pension plans undergoing distress or involuntary termination with valuation dates falling in 2024. This table is needed to compute the value of early retirement benefits and, thus, the total value of benefits under a plan.
Silicon Metal From the People's Republic of China: Continuation of Antidumping Duty Order
Document Number: 2023-26237
Type: Notice
Date: 2023-11-29
Agency: Department of Commerce, International Trade Administration
As a result of the determinations by the U.S. Department of Commerce (Commerce) and the U.S. International Trade Commission (ITC) that revocation of the antidumping duty (AD) order on silicon metal from the People's Republic of China (China) would likely lead to continuation or recurrence of dumping and material injury to an industry in the United States, Commerce is publishing this notice of continuation of the AD order.
Deregistration Under Section 8(f) of the Investment Company Act of 1940
Document Number: 2023-26236
Type: Notice
Date: 2023-11-29
Agency: Securities and Exchange Commission, Agencies and Commissions
Applicant seeks an order declaring that it has ceased to be an investment company. Applicant currently has 49 beneficial owners, is not presently making a public offering of securities and does not propose to make any public offering of securities. Applicant will continue to operate as a private investment fund in reliance on Section 3(c)(1) of the Act. Filing Date: The application was filed on October 30, 2023. Applicant's Address: 8310 South Valley Highway, Englewood, Colorado 80112.
Thermal Paper From the Republic of Germany: Preliminary Results of Antidumping Duty Administrative Review; 2021-2022
Document Number: 2023-26235
Type: Notice
Date: 2023-11-29
Agency: Department of Commerce, International Trade Administration
The U.S. Department of Commerce (Commerce) preliminarily determines that certain producers/exporters subject to this administrative review made sales of subject merchandise at less than normal value (NV) during the period of review (POR) of May 12, 2021, through October 31, 2022. Interested parties are invited to comment on these preliminary results.
Addition of Singapore to the List of Regions Affected by African Swine Fever
Document Number: 2023-26234
Type: Notice
Date: 2023-11-29
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
We are advising the public that we have added Singapore to the Animal and Plant Health Inspection Service (APHIS) list maintained on the APHIS website of regions considered to be affected with African swine fever (ASF). We have taken this action because of the confirmation of ASF in Singapore.
Boltless Steel Shelving Units Prepackaged for Sale From India: Preliminary Negative Determination of Sales at Less Than Fair Value and Postponement of Final Determination
Document Number: 2023-26233
Type: Notice
Date: 2023-11-29
Agency: Department of Commerce, International Trade Administration
The U.S. Department of Commerce (Commerce) preliminarily determines that boltless steel shelving units prepackaged for sale (boltless steel shelving) from India are not being, or not likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is April 1, 2022, through March 31, 2023. Interested parties are invited to comment on this preliminary determination.
Boltless Steel Shelving Units Prepackaged for Sale From Malaysia: Preliminary Affirmative Determination of Sales at Less Than Fair Value, Postponement of Final Determination, and Extension of Provisional Measures
Document Number: 2023-26232
Type: Notice
Date: 2023-11-29
Agency: Department of Commerce, International Trade Administration
The U.S. Department of Commerce (Commerce) preliminarily determines that boltless steel shelving units prepackaged for sale (boltless steel shelving) from Malaysia are being, or are likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is April 1, 2022, through March 31, 2023. Interested parties are invited to comment on this preliminary determination.
Reader Aids
Document Number: FR-2023-11-29-ReaderAids
Type: Reader Aids
Date: 2023-11-29
Death of Rosalynn Carter
Document Number: 2023-26350
Type: Proclamation
Date: 2023-11-29
Agency: Executive Office of the President
Determination of Regulatory Review Period for Purposes of Patent Extension; PYLARIFY
Document Number: 2023-26261
Type: Notice
Date: 2023-11-29
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 PYLARIFY 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 patents which claim that human drug product.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Terrorism Risk Insurance Program (TRIP)
Document Number: 2023-26259
Type: Notice
Date: 2023-11-29
Agency: Department of the Treasury
The Department of the Treasury will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on this request.
Determination of Regulatory Review Period for Purposes of Patent Extension; ORGOVYX
Document Number: 2023-26258
Type: Notice
Date: 2023-11-29
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 Orgovyx 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 patents which claims that human drug product.
Airworthiness Directives; Bombardier, Inc., Airplanes
Document Number: 2023-26257
Type: Rule
Date: 2023-11-29
Agency: Federal Aviation Administration, Department of Transportation
The FAA is adopting a new airworthiness directive (AD) for certain Bombardier, Inc., Model BD-100-1A10 airplanes. This AD was prompted by a design review of the avionic architecture of the pitch trim indication and alerting system that revealed software errors could generate misleading pitch trim indication to the crew, leading to incorrect horizontal stabilizer positioning at takeoff. This AD requires revising the Emergency Procedures and Normal Procedures of the existing airplane flight manual (AFM) to ensure the horizontal stabilizer is correctly configured prior to takeoff. The FAA is issuing this AD to address the unsafe condition on these products.
Determination of Regulatory Review Period for Purposes of Patent Extension; Tukysa
Document Number: 2023-26256
Type: Notice
Date: 2023-11-29
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 Tukysa 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 human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; Empaveli
Document Number: 2023-26255
Type: Notice
Date: 2023-11-29
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 Empaveli 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 human drug product.
Business Diversity Principles
Document Number: 2023-26254
Type: Notice
Date: 2023-11-29
Agency: Department of Commerce
The Department of Commerce is seeking public input on the draft Business Diversity Principles (BDP), which describe best practices related to diversity, equity, inclusion, and accessibility (DEIA) in the private sector, and on the impact of DEIA initiatives.
Determination of Regulatory Review Period for Purposes of Patent Extension; Olinvyk
Document Number: 2023-26253
Type: Notice
Date: 2023-11-29
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 Olinvyk 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 human drug product.
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