Unknown. Final amendment; order; confirmation of effective date
2,319 words·~11 min read·
/register/2025/08/21/2025-16046·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
--- schema: federal-register doc_type: fedreg source_file: FR-2025-08-21.xml --- 90 160 Thursday, August 21, 2025 Contents Agriculture Agriculture Department See Rural Business-Cooperative Service See Rural Utilities Service Census Bureau Census Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Annual Integrated Economic Survey, 40814-40816 2025-16018 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 40831-40833 2025-15935 2025-15981 Commerce Commerce Department See Census Bureau See International Trade Administration See National Oceanic and Atmospheric Administration See Patent and Trademark Office Comptroller Comptroller of the Currency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 40887-40889, 40891-40893 2025-15952 2025-15953 Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Lending Limits, 40889-40891 2025-15954 Drug Drug Enforcement Administration NOTICES Importer, Manufacturer or Bulk Manufacturer of Controlled Substances; Application, Registration, etc.: Cambrex Charles City, 40858-40859 2025-16005 Cambrex High Point, Inc., 40859-40860 2025-16002 2025-16003 Catalent CTS, LLC, 40860-40861 2025-16004 Continuus Pharmaceuticals, 40859 2025-16007 Vici Health Sciences, LLC, 40860 2025-16006 Election Election Assistance Commission NOTICES Petition of America First Legal Foundation for Rulemaking, 40825 2025-15930 Employment and Training Employment and Training Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Agricultural Recruitment System Forms Affecting Migratory Farm Workers, 40863-40864 2025-15957 Post Separation Data Collection for Former Job Corps Participants, 40862-40863 2025-15956 Energy Department Energy Department See Federal Energy Regulatory Commission Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Adequacy Status of the Klamath Falls, Oregon Submitted 2006 24-hour PM2.5 NAAQS Redesignation Request and Maintenance Plan Budgets for Transportation Conformity Purposes, 40737-40738 2025-15991 California;
Revised Format for Materials Incorporated by Reference, 40896-40956 2025-15989 Determination of Attainment by the Attainment Date; 2008 8-Hour Ozone Standards; California; Sacramento Metro Area, 40741-40746 2025-15990 Washington; Update to Materials Incorporated by Reference, 40738-40741 2025-15992 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Alabama; Standards for Granting Permits and Major New Source Review Permit Rules, 40793-40795 2025-15987 Arizona;
Maricopa County Air Quality Department; Petroleum Solvent Dry Cleaning, 40791-40793 2025-15984 Georgia; Removal of Emissions Statements Requirement and Updates to Permit by Rule, 40795-40797 2025-15986 Iowa, Muscatine; 2010 1-Hour SO2 Maintenance Plan and Redesignation, 40797-40812 2025-15983 NOTICES FIFRA Scientific Advisory Panel: Determining the Absence of Novel Proteins in the Saliva of Genetically Engineered Mosquitoes for Mosquito Control, 40829-40831 2025-15950 Federal Aviation Federal Aviation Administration PROPOSED RULES Airworthiness Directives:
Airbus Helicopters, 40786-40789 2025-16012 ATR—GIE Avions de Transport Regional Airplanes, 40778-40780 2025-15999 Gulfstream Aerospace LP (Type Certificate Previously Held by Israel Aircraft Industries, Ltd.) Airplanes, 40784-40786 2025-15982 MHI RJ Aviation ULC (Type Certificate Previously Held by Bombardier, Inc.) Airplanes, 40780-40784 2025-15998 Federal Deposit Federal Deposit Insurance Corporation PROPOSED RULES FDIC Official Signs, Advertisement of Membership, False Advertising, Misrepresentation of Insured Status, and Misuse of the FDIC's Name or Logo, 40767-40778 2025-16056 NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 40887-40889, 40891-40893 2025-15952 2025-15953 Federal Emergency Federal Emergency Management Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Federal Assistance for Offsite Radiological Emergency Preparedness and Planning, 40835-40836 2025-16016 National Urban Search and Rescue Response System, 40836-40837 2025-16015 State/Local/Tribal Hazard Mitigation Plans, 40837-40838 2025-16017 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 40826-40829 2025-15993 2025-15994 2025-15995 Effectiveness of Withdrawal of Water Quality Management Plan:
PacifiCorp, 40825 2025-16013 Institution of Section 206 Proceeding and Refund Effective Date: Ranchland Solar, LLC, 40825-40826 2025-16014 Federal Highway Federal Highway Administration RULES Rescinding Regulations on Procedures for Advance Construction of Federal-aid Projects, 40736-40737 2025-16008 NOTICES Final Federal Agency Action: Proposed Transportation Project in State Florida, 40882-40883 2025-15934 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 40887-40889, 40891-40893 2025-15952 2025-15953 Fish Fish and Wildlife Service NOTICES Permits; Applications, Issuances, etc.: Alabama Beach Mouse; Categorical Exclusion; Baldwin County, AL, 40839-40840 2025-15979 Food and Drug Food and Drug Administration RULES Listing of Color Additives Exempt from Certification: Butterfly Pea Flower Extract, 40704 2025-16045 Calcium Phosphate, 40703-40704 2025-16047 Galdieria Extract Blue, 40703 2025-16046 Medical Devices:
Clinical Chemistry and Clinical Toxicology Devices; Classification of the Menopause Test System, 40707-40709 2025-16036 Clinical Chemistry and Clinical Toxicology Devices; Classification of the Pharmacogenetic Assessment System, 40704-40707 2025-16037 Gastroenterology-Urology Devices; Classification of the Laparoscopic Gastrointestinal Sizing Tool, 40728-40730 2025-16041 Immunology and Microbiology Devices; Classification of A Multiplex Respiratory Panel to Detect and Identify Emerging Respiratory Pathogen(s) and Common Respiratory Pathogens in Human Clinical Specimens, 40709-40713 2025-16034 Immunology and Microbiology Devices;
Classification of the Anti-Phospholipase A2 Receptor Immunological Test System, 40724-40726 2025-16031 Immunology and Microbiology Devices; Classification of the Cancer Predisposition Risk Assessment System, 40716-40721 2025-16035 Immunology and Microbiology Devices; Classification of the Device that Detects Nucleic Acid Sequences from Microorganisms Associated with Vaginitis and Bacterial Vaginosis, 40726-40728 2025-16030 Immunology and Microbiology Devices; Classification of the Mutation Detection Test for Myeloproliferative Neoplasms, 40721-40724 2025-16038 Immunology and Microbiology Devices;
Classification of the Postnatal Chromosomal Copy Number Variation Detection System, 40713-40716 2025-16032 Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use with Non-Fusion Spinous Process Spacer Devices, 40730-40732 2025-16040 Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use with Total Disc Replacement Devices, 40732-40734 2025-16039 Radiology Devices; Classification of the Liver Iron Concentration Imaging Companion Diagnostic for Deferasirox, 40734-40736 2025-16033 NOTICES Hearings, Meetings, Proceedings, etc.:
Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments, 40833-40835 2025-15936 Health and Human Health and Human Services Department See Centers for Medicare & Medicaid Services See Food and Drug Administration See National Institutes of Health RULES Administrative Simplification: Modifications of Health Insurance Portability and Accountability Act, National Council for Prescription Drug Programs Retail Pharmacy Standards; and Modification of the Medicaid Pharmacy Subrogation Standard, 40746-40749 2025-15958 Homeland Homeland Security Department See Federal Emergency Management Agency Housing Housing and Urban Development Department NOTICES Notice Waiver:
Fair Housing Initiatives Program NOFOs, 40838-40839 2025-16021 Interior Interior Department See Fish and Wildlife Service See National Park Service See Surface Mining Reclamation and Enforcement Office NOTICES Hearings, Meetings, Proceedings, etc.: Invasive Species Advisory Committee, 40840-40841 2025-16028 Internal Revenue Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 40893-40894 2025-16009 2025-16010 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews:
Fiberglass Door Panels from the People's Republic of China, 40818-40821 2025-16043 Export Trade Certificate of Review, 40816-40817 2025-16026 Sales at Less Than Fair Value; Determinations, Investigations, etc.: Lattice Boom Crawler Cranes from Japan, 40817-40818 2025-16044 Justice Department Justice Department See Drug Enforcement Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Semi-Annual Progress Report for Grantees from the Sexual Assault Services Program Grants to Culturally Specific Programs, 40861-40862 2025-16042 Labor Department Labor Department See Employment and Training Administration National Highway National Highway Traffic Safety Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Factors That Influence the Effectiveness of Hazard Anticipation and Attention Maintenance Training, 40883-40886 2025-15931 National Institute National Institutes of Health NOTICES Hearings, Meetings, Proceedings, etc.: Eunice Kennedy Shriver National Institute of Child Health and Human Development, 40835 2025-16001 National Oceanic National Oceanic and Atmospheric Administration NOTICES Hearings, Meetings, Proceedings, etc.: North Pacific Fishery Management Council, 40823 2025-15955 Western Pacific Fishery Management Council, 40821-40823 2025-16019 National Park National Park Service NOTICES Inventory Completion:
College of Marin, Kentfield, CA, 40848-40849 2025-15972 Department of the Interior, Bureau of Land Management, Arizona State Office, Phoenix, AZ, 40857 2025-15978 Kansas State Historical Society, Topeka, KS, 40841-40843, 40853-40856 2025-15965 2025-15966 2025-15967 2025-15968 New York University, College of Dentistry, New York, NY, 40843-40844 2025-15975 San Diego State University, San Diego, CA, 40857-40858 2025-15973 The John Spellman Library at Grays Harbor College, Aberdeen, WA, 40841-40842 2025-15970 The University of Tennessee, Department of Anthropology, Knoxville, TN, 40847, 40850 2025-15959 2025-15960 The University of Tennessee, McClung Museum of Natural History and Culture, Knoxville, TN, 40846-40847 2025-15961 The Westfield Athenaeum, Westfield, MA, 40851 2025-15964 University of Illinois Urbana-Champaign, Champaign, IL, 40851-40852 2025-15976 University of Oregon Museum of Natural and Cultural History, Eugene, OR, 40845-40846 2025-15962 Repatriation of Cultural Items:
Old Dartmouth Historical Society, d.b.a. New Bedford Whaling Museum, New Bedford, MA, 40850-40851 2025-15974 Pacific Grove Museum of Natural History, Pacific Grove, CA, 40852-40853 2025-15963 Sonoma State University, Rohnert Park, CA, 40844-40845 2025-15971 Southern Ute Cultural Center and Museum, Ignacio, CO, 40856-40857 2025-15977 University of California, Santa Barbara, Santa Barbara, CA, 40847-40848 2025-15969 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Petition:
Holtec Palisades, LLC; Holtec Decommissioning International, LLC; Palisades Nuclear Plant, 40864-40868 2025-16022 Patent Patent and Trademark Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Complaints Regarding Invention Promoters, 40824-40825 2025-16000 Pipeline Pipeline and Hazardous Materials Safety Administration RULES Pipeline Safety: Periodic Standards Update II, 40749-40766 2025-15988 NOTICES Pipeline Safety: Request for Special Permit, 40886-40887 2025-16025 Postal Service Postal Service NOTICES International Product Change:
Priority Mail Express International, Priority Mail International and First-Class Package International Service Agreement, 40869 2025-15933 Rural Business Rural Business-Cooperative Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 40813 2025-16020 Rural Utilities Rural Utilities Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Seismic Safety of New Building Construction, 40813-40814 2025-16011 Securities Securities and Exchange Commission NOTICES Licenses;
Exemptions, Applications, Amendments, etc.: ICE Clear Credit LLC, 40879-40881 2025-15937 Self-Regulatory Organizations; Proposed Rule Changes: Cboe BZX Exchange, Inc., 40874, 40878-40879 2025-15941 2025-15942 2025-15943 2025-15944 MEMX LLC, 40872-40874 2025-15947 Nasdaq Stock Market LLC, 40869, 40877-40878 2025-15939 2025-15940 NYSE Arca, Inc., 40869-40870, 40874-40875, 40877 2025-15938 2025-15945 2025-15946 NYSE Texas, Inc., 40870-40872 2025-15949 The Options Clearing Corp., 40875-40876 2025-15948 Small Business Small Business Administration NOTICES Disaster Declaration:
Kansas, 40881 2025-15996 New Mexico, 40881 2025-15980 New Mexico; Public Assistance Only, 40882 2025-15997 Surface Mining Surface Mining Reclamation and Enforcement Office PROPOSED RULES Montana Regulatory Program, 40790-40791 2025-15985 Transportation Department Transportation Department See Federal Aviation Administration See Federal Highway Administration See National Highway Traffic Safety Administration See Pipeline and Hazardous Materials Safety Administration Treasury Treasury Department See Comptroller of the Currency See Internal Revenue Service NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Multiple FinCEN Information Collection Requests; Correction, 40894 2025-16048 Separate Parts In This Issue Part II Environmental Protection Agency, 40896-40956 2025-15989 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws. To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription. 90 160 Thursday, August 21, 2025 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 73 [Docket No.
FDA-2021-C-0925] Listing of Color Additives Exempt From Certification; Galdieria Extract Blue; Confirmation of Effective Date AGENCY: Food and Drug Administration, HHS. ACTION: Final amendment; order; confirmation of effective date. SUMMARY: The Food and Drug Administration (FDA or we) is confirming the effective date of June 26, 2025, for the final order that appeared in the **Federal Register** of May 12, 2025. The final order amends the color additive regulations to provide for the safe use of galdieria extract blue as a color additive at levels consistent with good manufacturing practice
(GMP)in: non-alcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milk shakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candy, soft candy and chewing gum, flavored frostings, ice cream and frozen dairy desserts, frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, whipped cream, yogurt, frozen or liquid creamers (including non-dairy alternatives), and whipped toppings (including non-dairy alternatives). DATES: The effective date of June 26, 2025, for the final order published in the **Federal Register** of May 12, 2025 (90 FR 20104), is confirmed. ADDRESSES: For access to the docket to read background documents or comments received, go to *https://www.regulations.gov* and insert the docket number found in brackets in the heading of this final order into the “Search” box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Stephanie A. Hice, Office of Food Chemical Safety, Dietary Supplements, and Innovation, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 301-348-1740 or Meridith L. Kelsch, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378. SUPPLEMENTARY INFORMATION: In the **Federal Register** of May 12, 2025 (90 FR 20104), we amended the color additive regulations to add § 73.167 (21 CFR 73.167) “Galdieria extract blue,” to provide for the safe use of galdieria extract blue as a color additive at levels consistent with GMP in: non-alcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milk shakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candy, soft candy and chewing gum, flavored frostings, ice cream and frozen dairy desserts, frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, whipped cream, yogurt, frozen or liquid creamers (including non-dairy alternatives), and whipped toppings (including non-dairy alternatives). We gave interested persons until June 11, 2025, to file objections or requests for a hearing (90 FR 20104). We received no objections or requests for a hearing on the final order. Therefore, we find that the effective date of the final order that published in the **Federal Register** of May 12, 2025, should be confirmed. List of Subjects in 21 CFR Part 73 Color additives, Cosmetics, Drugs, Foods, Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e) and under authority delegated to the Commissioner of Food and Drugs, we are giving notice that no objections or requests for a hearing were filed in response to the May 12, 2025, final order. Accordingly, the amendments issued thereby became effective June 26, 2025. Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2025-16046 Filed 8-20-25; 8:45 am]
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