{"description":"Documents matching 'compounding', published on or after 07/24/2026, and from Food and Drug Administration","count":18,"total_pages":1,"results":[{"title":"Compounding Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #256B entitled \"Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities.\" This draft guidance, when finalized, will describe FDA's current thinking regarding the circumstances under which we generally do not intend to take action against the compounding of animal drug products from bulk drug substances (BDS) when done in accordance with Current Good Manufacturing Practice (CGMP) at drug production facilities that are registered with FDA.","document_number":"2026-17580","html_url":"https://www.federalregister.gov/documents/2026/08/28/2026-17580/compounding-animal-drugs-from-bulk-drug-substances-compounding-under-cgmp-in-federally-registered","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-28/pdf/2026-17580.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17580.pdf?1787834714","publication_date":"2026-08-28","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"to determine the circumstances surrounding the <span class=\"match\">compounding</span> activity. Except with regard to one proposed item, the routine business records kept by pharmacists who <span class=\"match\">compound</span> animal drugs from BDS who <span class=\"match\">compound</span> animal drugs from BDS, as well as veterinarians prescribing <span class=\"match\">compounded</span> animal drugs within a valid veterinarian-client-patient relationship, should be adequate to ascertain if the circumstances described in the draft guidance exist. \n The draft guidance provides recommendations for the <span class=\"match\">compounding</span> of animal drugs from bulk drug substances at "},{"title":"Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry titled \"Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates.\" This guidance describes the FDA's regulatory and enforcement priorities regarding the compounding of certain starter parenteral nutrition drug products for neonates by outsourcing facilities and by State-licensed pharmacies and Federal facilities that are not registered with FDA as outsourcing facilities. This guidance is being published for immediate implementation due to the expected market exit of the predominant source of certain starter parenteral nutrition drug products for neonates in the United States.","document_number":"2026-18368","html_url":"https://www.federalregister.gov/documents/2026/09/09/2026-18368/temporary-policies-for-compounding-certain-starter-parenteral-nutrition-drug-products-for-neonates","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-09/pdf/2026-18368.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18368.pdf?1788552907","publication_date":"2026-09-09","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"ACTION: \n Notice of availability. \n \n \n SUMMARY: \n The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry titled “Temporary Policies for <span class=\"match\">Compounding</span> Certain Starter Parenteral Nutrition Drug Products for Neonates.” This guidance describes the FDA's regulatory and enforcement priorities regarding the <span class=\"match\">compounding</span> of certain starter parenteral nutrition drug products for neonates by outsourcing facilities and by State-licensed pharmacies and Federal facilities that are not registered with FDA as outsourcing"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) 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 the information collection pertaining to the registration of human drug compounding outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and associated fees.","document_number":"2026-17676","html_url":"https://www.federalregister.gov/documents/2026/08/31/2026-17676/agency-information-collection-activities-proposed-collection-comment-request-registration-of-human","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-31/pdf/2026-17676.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17676.pdf?1787921110","publication_date":"2026-08-31","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Drug <span class=\"match\">Compounding</span> Outsourcing Facilities guidance \n 90 \n 1 \n 90 \n 0.5 (30 minutes) \n 45 \n \n \n Request for Small Business Reduction (Form FDA 3908) \n 8 \n 1 \n 8 \n 25 \n 200 \n \n \n Reinspection Fees; Section C. of the Fees for Human Drug <span class=\"match\">Compounding</span> Outsourcing Facilities guidance \n 12 \n 1 \n 12 \n 0.5 (30 minutes) \n 6 \n \n \n Reconsideration Requests; Section V.B.1. of the Fees for Human Drug <span class=\"match\">Compounding</span> Outsourcing Facilities guidance \n 1 \n 1 \n 1 \n 1 \n 1 \n \n \n Appeal of Reconsideration Denials; Section V.B.2. of the Fees for Human Drug <span class=\"match\">Compounding</span> Outsourcing"},{"title":"Outsourcing Facility Fee Rates for Fiscal Year 2027","type":"Notice","abstract":"The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2027 rates for the establishment and reinspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a reinspection fee for each reinspection of an outsourcing facility. This document establishes the FY 2027 rates for the small business establishment fee ($7,142), the non-small business establishment fee ($22,074), and the reinspection fee ($21,427) for outsourcing facilities; provides information on how the fees for FY 2027 were determined; and describes the payment procedures outsourcing facilities should follow.","document_number":"2026-15342","html_url":"https://www.federalregister.gov/documents/2026/07/30/2026-15342/outsourcing-facility-fee-rates-for-fiscal-year-2027","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-30/pdf/2026-15342.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-15342.pdf?1785329113","publication_date":"2026-07-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"CONTACT: \n \n For more information on human drug <span class=\"match\">compounding</span> and outsourcing facility fees, visit FDA's website at: \n https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-<span class=\"match\">compounding</span>. For questions relating to this notice: \n Olufunmilayo Ariyo, Office of Financial Management, Food and Drug Administration, 301-796-7900; or \n FDAUserFees@fda.hhs.gov. \n \n \n \n \n SUPPLEMENTARY INFORMATION: \n I. Background \n Under section 503B of the FD&amp;C Act (21 U.S.C. 353b), a human drug <span class=\"match\">compounder</span> can register with FDA as an “outsourcing facility"},{"title":"Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals","type":"Notice","abstract":"The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.","document_number":"2026-16716","html_url":"https://www.federalregister.gov/documents/2026/08/17/2026-16716/agency-information-collection-activities-announcement-of-office-of-management-and-budget-approvals","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-17/pdf/2026-16716.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-16716.pdf?1786711513","publication_date":"2026-08-17","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"5/31/2029 \n \n \n Human Drug <span class=\"match\">Compounding</span> Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act \n 0910-0800 \n 5/31/2029 \n \n \n Medical Device Accessories \n 0910-0823 \n 3/31/2029 \n \n \n Data To Support Social and Behavioral Research as Used by the Food and Drug Administration \n 0910-0847 \n 5/31/2029 \n \n \n Generic Clearance for Quick Turnaround Testing of Communication Effectiveness \n 0910-0876 \n 4/30/2029 \n \n \n Obtaining Information to Understand and Challenges and Opportunities Encountered by <span class=\"match\">Compounding</span> Outsourcing Facilities \n 0910-0883"},{"title":"Statement of Organization, Functions, and Delegations of Authority","type":"Notice","abstract":"The Food and Drug Administration's (FDA) plans to centralize and enhance key functions across the agency. These changes will reduce redundancies, improve efficiency, and advance alignment to better serve the American public.","document_number":"2026-15297","html_url":"https://www.federalregister.gov/documents/2026/07/29/2026-15297/statement-of-organization-functions-and-delegations-of-authority","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-29/pdf/2026-15297.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-15297.pdf?1785251709","publication_date":"2026-07-29","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"(DCDFE2) \n PROGRAM AND REGULATORY OPERATIONS STAFF 3 (DCDFE4) \n OFFICE OF <span class=\"match\">COMPOUNDING</span> QUALITY AND COMPLIANCE (DCDFF) \n DIVISION OF <span class=\"match\">COMPOUNDING</span> I (DCDFFA) \n <span class=\"match\">COMPOUNDING</span> BRANCH 1 (DCDFFA1) \n <span class=\"match\">COMPOUNDING</span> BRANCH 2 (DCDFFA2) \n <span class=\"match\">COMPOUNDING</span> BRANCH 3 (DCDFFA3) \n DIVISION OF <span class=\"match\">COMPOUNDING</span> II (DCDFFB) \n <span class=\"match\">COMPOUNDING</span> BRANCH 4 (DCDFFB2) \n <span class=\"match\">COMPOUNDING</span> BRANCH 5 (DCDFFB3) \n <span class=\"match\">COMPOUNDING</span> BRANCH 6 (DCDFFB4) \n DIVISION OF <span class=\"match\">COMPOUNDING</span> III (DCDFFC) \n <span class=\"match\">COMPOUNDING</span> BRANCH 7 (DCDFFC3) \n <span class=\"match\">COMPOUNDING</span> BRANCH 8 (DCDFFC4) \n OFFICE OF NEW DRUGS (DCDG) \n PROGRAM MANAGEMENT ANALYSIS"},{"title":"Medical Device User Fee Rates for Fiscal Year 2027","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2027. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2027, which apply from October 1, 2026, through September 30, 2027, and provides information on how the fees for FY 2027 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.","document_number":"2026-15335","html_url":"https://www.federalregister.gov/documents/2026/07/30/2026-15335/medical-device-user-fee-rates-for-fiscal-year-2027","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-30/pdf/2026-15335.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-15335.pdf?1785329112","publication_date":"2026-07-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"equal to 1.04 (see section 738(c)(2)(C)(ii)(II) of the FD&amp;C Act). The total base inflation adjustment for FY 2027 is 1.04. \n MDUFA V provides for this inflation adjustment to be <span class=\"match\">compounded</span> for FY 2023 and each subsequent fiscal year (see section 738(c)(2)(B) of the FD&amp;C Act). To complete the <span class=\"match\">compounded</span> inflation adjustment for FY 2027, the FY 2026 <span class=\"match\">compounded</span> adjustment (1.167391) is multiplied by the FY 2027 base inflation adjustment (1.040000) to reach the applicable inflation adjustment of 1.214087 (rounded) for FY 2027. We then multiply"},{"title":"Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate","type":"Rule","abstract":"The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium DL- methionine chelate as a nutritional source of chromium in cattle feed. This action is in response to a food additive petition filed by Zinpro Corp.","document_number":"2026-16942","html_url":"https://www.federalregister.gov/documents/2026/08/19/2026-16942/food-additives-permitted-in-feed-and-drinking-water-of-animals-chromium-dl-methionine-chelate","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-19/pdf/2026-16942.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-16942.pdf?1787057120","publication_date":"2026-08-19","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"metabolites, or degradation products in the environment. The proposed use of this substance falls within the categorical exclusion because chromium DL-methionine chelate completely dissociates into chromium and DL-methionine, both of which are naturally occurring <span class=\"match\">compounds</span>, and excretion of these <span class=\"match\">compounds</span> into the environment by cattle is not expected to significantly alter their concentration or distribution. The Agency is not aware of any extraordinary circumstances. Therefore, neither an environmental assessment nor an environmental impact statement is"},{"title":"International Drug Scheduling; Single Convention on Narcotic Drugs; Convention on Psychotropic Substances; Clobromazolam (Phenazolam); Cychlorphine (N-Propionitrile Chlorphine); Desalkylgidazepam (Bromonordiazepam); Ethylbromazolam; Etomethazene (5-Methyl Etodesnitazene); Spirochlorphine (R6980); Etomidate; Medetomidine; Request for Comments","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is providing interested persons with the opportunity to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of eight drug substances. These comments will be considered in preparing a response from the United States to the Expert Committee on Drug Dependence (ECDD) regarding the abuse liability and diversion of these drugs. The ECDD will use this information to consider whether to recommend that certain international restrictions be placed on these drug substances. This notice requesting comments is required by the Controlled Substances Act (CSA).","document_number":"2026-17380","html_url":"https://www.federalregister.gov/documents/2026/08/26/2026-17380/international-drug-scheduling-single-convention-on-narcotic-drugs-convention-on-psychotropic","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-26/pdf/2026-17380.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17380.pdf?1787661911","publication_date":"2026-08-26","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"July 2025; by October 2025, the <span class=\"match\">compound</span> had been detected in 13 toxicology cases and 93 drug material cases originating from multiple U.S. states. The substance has frequently been found in counterfeit pharmaceutical tablets misrepresented as diazepam, alprazolam, or clonazepam. Bromazolam-like effects have been described anecdotally by users as producing euphoria, increased confidence, empathy, hypnosis, sedation, muscle relaxation and amnesia consistent with the effects of other benzodiazepine-related <span class=\"match\">compounds</span>. There are no approved commercial"},{"title":"Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027","type":"Notice","abstract":"The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Over-the-Counter Monograph Drug User Fee Amendments (herein referred to as \"OMUFA II\"), authorizes the Food and Drug Administration (FDA, the Agency, or we) to assess and collect user fees from qualifying manufacturers of over-the-counter (OTC) monograph drugs and submitters of OTC monograph order requests (OMORs) for fiscal years 2026 through 2030. This notice publishes the OMUFA fee rates for fiscal year (FY) 2027.","document_number":"2026-15344","html_url":"https://www.federalregister.gov/documents/2026/07/30/2026-15344/over-the-counter-monograph-drug-user-fee-rates-for-fiscal-year-2027","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-30/pdf/2026-15344.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-15344.pdf?1785329113","publication_date":"2026-07-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"processing activities are repackaging, relabeling, or testing). See also 21 CFR 207.1 (addressing drug establishment registration), stating that “[m]anufacture means each step in the manufacture, preparation, propagation, <span class=\"match\">compounding</span>, or processing of a drug,” and indicating that “the term `manufacture, preparation, propagation, <span class=\"match\">compounding</span>, or processing,' as used in section 510 of the Federal Food, Drug, and Cosmetic Act, includes relabeling, repackaging, and salvaging activities.”\n \n \n Those facilities that only manufacture the active pharmaceutical"},{"title":"Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal","type":"Notice","abstract":"The Food and Drug Administration (FDA) is announcing the renewal of the Cardiovascular and Renal Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Cardiovascular and Renal Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the August 27, 2028, expiration date.","document_number":"2026-16999","html_url":"https://www.federalregister.gov/documents/2026/08/20/2026-16999/advisory-committee-cardiovascular-and-renal-drugs-advisory-committee-renewal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-20/pdf/2026-16999.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-16999.pdf?1787143523","publication_date":"2026-08-20","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"(Administratively Inactive) \n • Nonprescription Drugs Advisory Committee \n • Obstetrics, Reproductive and Urologic Drugs Advisory Committee \n • Oncologic Drugs Advisory Committee \n • Pediatric Advisory Committee \n • Peripheral and Central Nervous System Advisory Committee \n • Pharmacy <span class=\"match\">Compounding</span> Advisory Committee \n • Psychopharmacologic Drugs Advisory Committee \n • Pulmonary-Allergy Drugs Advisory Committee \n • Risk Communication Advisory Committee (Administratively Inactive) \n • Science Board to the Food and Drug Administration \n • Technical and Electronic Product"},{"title":"Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2027","type":"Notice","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing the fee rates and payment procedures for fiscal year (FY) 2027 generic new animal drug program user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2023 (AGDUFA IV), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs (JINADs), and for certain submissions related to JINAD files. This notice establishes the fee rates for FY 2027.","document_number":"2026-15341","html_url":"https://www.federalregister.gov/documents/2026/07/30/2026-15341/animal-generic-drug-user-fee-program-rates-and-payment-procedures-for-fiscal-year-2027","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-30/pdf/2026-15341.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-15341.pdf?1785329113","publication_date":"2026-07-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"component (3.1133 percent) to the non-payroll component (1.4367 percent), for an inflation adjustment of 4.5500 percent for FY 2027. \n Section 741(c)(2)(B) of the FD&amp;C Act provides for the inflation adjustment to be <span class=\"match\">compounded</span> each fiscal year after FY 2025. The inflation adjustment for FY 2027 (4.5500 percent) is <span class=\"match\">compounded</span> by adding 1 and then multiplying by 1 plus the inflation adjustment factor for FY 2026 (1.0896), which equals 1.1392 (rounded) (1.0896 multiplied by 1.0455). We then multiply the base revenue amount for FY 2027 ($25,000"},{"title":"Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee; Renewal","type":"Notice","abstract":"The Food and Drug Administration (FDA) is announcing the renewal of the Endocrinologic and Metabolic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Endocrinologic and Metabolic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the August 27, 2028, expiration date.","document_number":"2026-16998","html_url":"https://www.federalregister.gov/documents/2026/08/20/2026-16998/advisory-committee-endocrinologic-and-metabolic-drugs-advisory-committee-renewal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-20/pdf/2026-16998.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-16998.pdf?1787143523","publication_date":"2026-08-20","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"(Administratively Inactive) \n • Nonprescription Drugs Advisory Committee \n • Obstetrics, Reproductive and Urologic Drugs Advisory Committee \n • Oncologic Drugs Advisory Committee \n • Pediatric Advisory Committee \n • Peripheral and Central Nervous System Advisory Committee \n • Pharmacy <span class=\"match\">Compounding</span> Advisory Committee \n • Psychopharmacologic Drugs Advisory Committee \n • Pulmonary-Allergy Drugs Advisory Committee \n • Risk Communication Advisory Committee (Administratively Inactive) \n • Science Board to the Food and Drug Administration \n • Technical and Electronic Product"},{"title":"Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2027","type":"Notice","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing the fee rates and payment procedures for fiscal year (FY) 2027 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Drug User Fee Amendments of 2023 (ADUFA V), authorizes FDA to collect user fees for certain animal drug applications and supplemental animal drug applications, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2027.","document_number":"2026-15339","html_url":"https://www.federalregister.gov/documents/2026/07/30/2026-15339/animal-drug-user-fee-rates-and-payment-procedures-for-fiscal-year-2027","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-30/pdf/2026-15339.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-15339.pdf?1785329112","publication_date":"2026-07-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"component (3.1133 percent) to the non-payroll component (1.4367 percent), for an inflation adjustment of 4.5500 percent for FY 2027. \n Section 740(c)(2)(B) of the FD&amp;C Act provides for the inflation adjustment to be <span class=\"match\">compounded</span> each fiscal year after FY 2025. The inflation adjustment for FY 2027 (4.5500 percent) is <span class=\"match\">compounded</span> by adding 1 and then multiplying by 1 plus the inflation adjustment factor for FY 2026 (1.0896), which equals 1.1392 (rounded) (1.0896 multiplied by 1.0455). We then multiply the base revenue amount for FY 2027 ($33,500"},{"title":"Fee Rate for Using a Priority Review Voucher in Fiscal Year 2027","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a priority review voucher for fiscal year (FY) 2027. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, authorizes FDA to determine and collect priority review user fees for certain applications for review of human drug or biological products when those applications use a tropical disease, rare pediatric disease, or material threat medical countermeasure (MCM) priority review voucher. These vouchers are awarded to the sponsors of tropical disease, rare pediatric disease, or material threat MCM product applications, respectively, that meet the requirements of the FD&C Act, upon FDA approval of such applications. The amount of the fee for using a priority review voucher is determined each fiscal year, based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous fiscal year, and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the FY 2027 priority review fee rate applicable to submission of eligible applications for review of human drug or biological products using a tropical disease, rare pediatric disease, or material threat MCM priority review voucher and outlines the payment procedures for such fees.","document_number":"2026-18464","html_url":"https://www.federalregister.gov/documents/2026/09/10/2026-18464/fee-rate-for-using-a-priority-review-voucher-in-fiscal-year-2027","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18464.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18464.pdf?1788957915","publication_date":"2026-09-10","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"amount by which FDA's average costs increased in the 3 years prior to FY 2026, to adjust the FY 2025 amount for cost increases in FY 2026. That adjustment, published in the \n Federal Register \n setting the FY 2027 PDUFA fees, is 4.7210 percent for the most recent year, not <span class=\"match\">compounded</span>. Increasing the FY 2025 incremental priority review cost of $1,717,512 by 4.7210 percent (or 0.047210) results in an estimated cost of $1,798,596 (rounded to the nearest dollar). This is the priority review user fee amount for FY 2027 that must be submitted in connection"},{"title":"Advisory Committee; Oncologic Drugs Advisory Committee; Renewal","type":"Notice","abstract":"The Food and Drug Administration (FDA) is announcing the renewal of the Oncologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Oncologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the September 1, 2028, expiration date.","document_number":"2026-17084","html_url":"https://www.federalregister.gov/documents/2026/08/21/2026-17084/advisory-committee-oncologic-drugs-advisory-committee-renewal","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-21/pdf/2026-17084.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-17084.pdf?1787229913","publication_date":"2026-08-21","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"Assurance Advisory Committee (Administratively Inactive) \n • Nonprescription Drugs Advisory Committee \n • Obstetrics, Reproductive and Urologic Drugs Advisory Committee \n • Pediatric Advisory Committee \n • Peripheral and Central Nervous System Advisory Committee \n • Pharmacy <span class=\"match\">Compounding</span> Advisory Committee \n • Psychopharmacologic Drugs Advisory Committee \n • Pulmonary-Allergy Drugs Advisory Committee \n • Risk Communication Advisory Committee (Administratively Inactive) \n • Science Board to the Food and Drug Administration \n • Technical Electronic Product"},{"title":"Micro-Tracers, Inc.; Response to Objections and Requests for a Public Hearing","type":"Rule","abstract":"The Food and Drug Administration (FDA or we) received objections and requests for a public hearing submitted by Buchanan Ingersoll & Rooney PC, on behalf of Micro-Tracers, Inc. (Micro-Tracers or objector), on the order granting a color additive petition (3C0323) requesting that we repeal specified regulations to no longer provide for the safe use of FD&C Red No. 3 in food (including dietary supplements) and ingested drugs. After reviewing the objections, we have concluded that the objections do not raise issues of material fact that justify a hearing. We are also providing notice that the administrative stay of the effective date for the repeal and delisting of the color additive regulations is now lifted.","document_number":"2026-15920","html_url":"https://www.federalregister.gov/documents/2026/08/05/2026-15920/micro-tracers-inc-response-to-objections-and-requests-for-a-public-hearing","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-05/pdf/2026-15920.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-15920.pdf?1785847517","publication_date":"2026-08-05","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"no residue of a color additive will be found in food derived from animals that consume feed containing that color additive (section 721(b)(5)(B) of the FD&amp;C Act). This method of examination is known as a “regulatory method.” FDA has codified the steps a sponsor of a <span class=\"match\">compound</span> must follow to establish a regulatory method in 21 CFR part 500, subpart E. Notably, the sponsor is responsible for submitting a proposed method and providing data to show that the method satisfies FDA's operational definition of “no residue” (see 21 CFR 500.88). There is"},{"title":"Substances Generally Recognized as Safe","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).","document_number":"2026-16296","html_url":"https://www.federalregister.gov/documents/2026/08/11/2026-16296/substances-generally-recognized-as-safe","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-11/pdf/2026-16296.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-16296.pdf?1786374907","publication_date":"2026-08-11","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"the TOR process for the intended use of a food substance that is purported to be GRAS and meets the TOR criteria. \n We propose revising § 170.39(a) to update scientific terminology and reflect updated approaches to account for the assessment of cancer risk of carcinogenic <span class=\"match\">compounds</span>. Our regulation, at § 170.39(a)(2)(i), states that the use in question must result in a dietary concentration of the FCS at or below 0.5 parts per billion corresponding to dietary exposure levels at or below 1.5 micrograms per person per day (based on a diet of 1,500 grams"}]}