Food Safety

This regulation establishes an exemption from the requirement of a tolerance for residues of rice bran wax (CAS Reg. No. 8016-60-2) when used as an inert ingredient (lubricant) on growing crops and raw agricultural commodities pre- and post-harvest, when applied to animals, and in antimicrobial formulations applied to food-contact surfaces in public eating places, dairy-processing equipment, and food- processing equipment and utensils. Micro Powders, Inc., submitted a petition to EPA under the F...

The Food and Drug Administration (FDA or we) is requesting information on the current uses and safety data of butylated hydroxyanisole (BHA) in human food and as a food contact substance. We are requesting this information as part of our systematic process for conducting post-market assessments of chemicals in food. We are conducting a post-market assessment of the safety of BHA in food, considering the latest state of the science. We intend to use the information received and any other availabl...

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded use of spirulina (Arthrospira platensis) extract as a color additive in human foods generally (except for infant formula, certain foods subject to regulation by the U.S. Department of Agriculture, and foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of the added color is authorized by such standards...

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of beetroot red for the coloring of human foods generally, at levels consistent with current good manufacturing practice, except in products under the jurisdiction of the United States Department of Agriculture (USDA), infant formula, or foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), unless the use of...

This regulation establishes an exemption from the requirement of a tolerance for residues of chlorate (CAS Reg. No. 7775-09-9) in or on several food commodities. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), TriNova LLC submitted a petition to EPA requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of this pesticide when used in accordance with the terms of the exemption....

The Food and Drug Administration (FDA or we) received a citizen petition from Celiac Journey requesting that we act to protect consumers with celiac disease by requiring that all ingredients with gluten be listed by name in the ingredient list and by requiring cross- contact controls with gluten-containing grains. We are issuing this document to request comment on the issues raised in the petition and on specific questions related to these issues....

The U.S. Codex Office is sponsoring a public meeting on March 3, 2026. The objective of the public meeting is to provide information and receive public comments on agenda items and draft U.S. position to be discussed at the 56th Session of the Codex Committee on Food Additives (CCFA) of the Codex Alimentarius Commission (CAC). CCFA will be held in Chongqing, China, from April 13-17, 2026. The U.S. Manager for Codex Alimentarius and the Under Secretary for Trade and Foreign Agricultural Affairs r...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products." This document provides guidance on the appropriate use of Bayesian methods in clinical trials. The primary focus is on the use of Bayesian methods to support primary inference in pivotal clinical trials designed to support the effectiveness and safety of drug and biological products....

The Food and Drug Administration (FDA, Agency, or we) has determined that MYSOLINE (primidone) suspension, 250 milligrams (mg)/5 milliliters (mL), was withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for primidone suspension, 250 mg/5 mL....

The Food and Drug Administration (FDA or Agency) has determined that EFFEXOR XR (venlafaxine hydrochloride) extended-release capsule, 100 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and r...

The Food and Drug Administration (FDA, Agency, or we) has determined that DEXCHLORPHENIRAMINE MALEATE (dexchlorpheniramine maleate, oral syrup, 2 milligrams (mg)/5 milliliters (ml)), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as th...

The Food and Drug Administration (FDA, the Agency, or we) is classifying the electrical tongue nerve stimulator to treat motor deficits into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the classification of the electrical tongue nerve stimulator to treat motor deficits. We are taking this action because we have determined that classifying the device into class II will provide a reasonab...

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled "Sponsor Responsibilities--Safety Reporting Requirements and Safety Assessment for Investigational New Drug Application and Bioavailability/Bioequivalence Studies." The guidance provides recommendations for sponsors and sponsor-investigators to comply with the requirements of investigational new drug application (IND) safety reporting and safety reporting for bioavailabil...

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for investigators, industry, and institutional review boards (IRBs) entitled "Investigator Responsibilities--Safety Reporting for Investigational Drugs and Devices." The guidance is intended to help clinical investigators comply with the safety reporting requirements for investigational new drug application (IND) studies and investigational device exemption (IDE) studies. As such, recommendati...

Section 106(a) of the Consumer Product Safety Improvement Act of 2008 (CPSIA) mandates that ASTM F963 shall be a mandatory toy safety standard. ASTM F963-23, however, does not establish specific performance requirements for aquatic toys, such as neck floats. The U.S. Consumer Product Safety Commission (CPSC or Commission) is issuing this final rule establishing additional performance requirements specifically for neck floats and revised labeling requirements for neck floats to address fatal haza...

On December 2, 2025, FSIS announced that it will hold a public meeting on January 14, 2026, to discuss practical strategies for reducing Salmonella illnesses attributed to poultry products. FSIS is now changing the meeting time to accommodate logistical needs. This meeting supports USDA's broader food safety initiative and follows the withdrawal of the previous Salmonella framework proposed rule in response to issues raised in the public comments. FSIS is seeking input on how to address Salmonel...

The Food and Drug Administration (FDA or Agency) has determined that BACTROBAN (mupirocin) nasal ointment, 2%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for mupirocin nasal ointment, 2%, if all other legal and regulatory requirements are met....

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements....

Section 106(a) of the Consumer Product Safety Improvement Act of 2008 (CPSIA) mandates that ASTM F963 shall be a mandatory toy safety standard. This safety standard sets forth requirements for water bead toys and toys that contain water beads. Under this statutory authority, the U.S. Consumer Product Safety Commission (CPSC or Commission) is issuing a safety standard for water bead toys and toys that contain water beads....

The Food and Drug Administration (FDA or Agency) has determined that LUNELLE (estradiol cypionate and medroxyprogesterone acetate) injectable, 5 milligrams (mg)/0.5 milliliter (mL) estradiol cypionate and 25 mg/0.5 mL medroxyprogesterone acetate, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for estradiol cypionate and medroxyprogesterone acetate injectable, 5 mg/0.5 mL estradiol cypionat...

The Food and Drug Administration (FDA or Agency) has determined that ZANTAC (ranitidine hydrochloride (HCl)) injection, equivalent to (EQ) 25 milligram (mg) base/milliliter (mL), has not been withdrawn from sale for reasons of safety or effectiveness to the extent that the drug can be manufactured or formulated in a manner that satisfies any applicable acceptable intake limit for nitrosamine impurities. This determination means that FDA will not begin procedures to withdraw approval of abbreviat...

The Food and Drug Administration (FDA, the Agency, or we) is announcing a request for information from interested parties and the public to share their perspectives with FDA on testosterone replacement therapy for men. The Agency intends to use the information submitted to help inform considerations related to testosterone therapy for men....

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 c...

The Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) is announcing its Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot ("TEMPO pilot"), in connection with the Center for Medicare and Medicaid Innovation (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model, to promote access to certain digital health devices while safeguarding patient safety....

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Monoclonal Antibodies: Streamlined Nonclinical Safety Studies." The draft guidance provides recommendations for streamlined approaches to assess long-term safety from monoclonal antibodies that recognize a single molecular target (referred to as monospecific antibodies); describes when general toxicology studies are not warranted or may be limited to a short-term study; and ...

FSIS will hold a public meeting on January 14, 2026, to discuss practical strategies for reducing Salmonella illnesses attributed to poultry products. This meeting supports USDA's broader food safety initiative and follows the withdrawal of the previous Salmonella framework proposed rule in response to issues raised in the public comments. FSIS is seeking input on how to address Salmonella through better use of data, alternative performance standard parameters, and policy options that reflect bo...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Q3E Guideline for Extractables and Leachables" and a draft supporting document entitled "Supporting Documentation: Class 3 Leachable Monographs." The draft guidance and supporting document were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance presents a holistic fr...

The Food and Drug Administration (FDA, the Agency, or we) is classifying the field generator positioning device into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices in part by reducing regulatory burdens....

The Food and Drug Administration (FDA, the Agency, or we) is classifying the anchored esophageal sheath into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the classification of the anchored esophageal sheath. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of t...

The Food and Drug Administration (FDA) is proposing to reclassify certain postamendments class III nucleic acid-based test systems indicated for use with a corresponding approved oncology therapeutic product (product codes OWD, PJG, PQP, and SFL) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation, along with the special controls that FDA believes are necessary to provide a reasonabl...

This regulation establishes a tolerance action for residues of cyclobutrifluram in or on the food and feed commodities of cotton, gin byproducts; cotton, undelinted seed; lettuce, leaf; soybean, seed. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), Syngenta submitted a petition to EPA requesting that EPA establish a maximum permissible level for residues of this pesticide in or on the identified commodities....

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Environmental Assessment Reporting System (NEARS). This system collects dat...

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.

The Food and Drug Administration (FDA or Agency) has determined that SEMPREX-D (acrivastine and pseudoephedrine hydrochloride) capsules, 8 milligrams (mg) and 60 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for acrivastine and pseudoephedrine hydrochloride capsules, 8 mg and 60 mg, if all other legal and regulatory requirements are met....

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.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled "Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products; Draft Guidance for Industry." The draft guidance document discusses methods and approaches for capturing postapproval safety and efficacy data for cell and gene therapy (CGT) products. Given the potential for long-lasting effects of CGT products, and the generally limited number of participa...

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its prior notice regulation to add a requirement that prior notice and food facility registration information be submitted within a certain timeframe after certain notices of refusal or hold have been issued ("post-refusal" and "post-hold" submission) or responses to requests for FDA review have been issued and beginning October 1, 2026, add a requirement that the prior notice for articles of food arriving...

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.

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Computer Software Assurance for Production and Quality System Software." FDA is issuing this guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system. FDA believes that these recommendations will help foster the adoption and use of innovative technologies that pro...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Safety Labeling Changes--Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act." This draft guidance provides information on the implementation of the statutory provision that authorizes FDA to require application holders for certain drug and biological products to make labeling changes based on new safety information that becomes available after ap...

The Food and Drug Administration (FDA) is issuing a final order reclassifying qualitative hepatitis B virus (HBV) antigen assays (product code LOM), HBV antibody assays (product code LOM), and quantitative HBV nucleic acid-based assays (product code MKT), all of which are postamendments class III devices, into class II (special controls), subject to premarket notification. FDA is also establishing the special controls that are necessary to provide a reasonable assurance of safety and effectivene...

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Erosive Esophagitis: Developing Drugs for Treatment." The draft guidance details recommendations on clinical trials for drugs being developed for the healing of erosive esophagitis (EE) and maintenance of healed EE in adults, including considerations for eligibility criteria, trial design features, efficacy evaluations, and safety assessments....

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment." The draft guidance details FDA's recommendations on the clinical trials for drugs being developed for the treatment of symptomatic nonerosive gastroesophageal reflux disease (sGERD) in adults, including considerations for eligibility criteria, trial design features, efficacy evaluat...

FSIS is announcing the availability of and requesting comments on a new guideline titled FSIS Guideline for Applying for USDA FSIS Inspection. FSIS developed this guideline to provide businesses interested in applying for FSIS inspection with information about determining the need for FSIS inspection, products exempt from routine inspection, the application process, FSIS verification activities, and resources to support new applicants....

The Food and Drug Administration (FDA or we) 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.

The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of vitamin D<INF>3</INF> as a nutrient supplement in yogurt and other cultured dairy products fermented with Lactobacillus delbrueckii, subspecies bulgaricus (L. delbrueckii, subsp. bulgaricus), and Streptococcus thermophilus (S. thermophilus) at a level higher than is currently permitted. We are taking this action in response to a food additive petition filed by General Mills, Inc....

The Food and Drug Administration (FDA or we) is amending the food additive regulation to provide for the safe use of hydrogen peroxide in food as an antimicrobial agent, oxidizing and reducing agent, and bleaching agent, and to remove sulfur dioxide. We are taking this action in response to a food additive petition filed by Cargill, Inc. (Cargill or petitioner)....

The Food and Drug Administration (FDA, the Agency, or we) 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.

The Food and Drug Administration (FDA or Agency) has determined that NUTRACORT (hydrocortisone) topical gel, 1%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for NUTRACORT (hydrocortisone) topical gel, 1%, if all other legal and regulatory requirements are met....

In accordance with the Paperwork Reduction Act requirement, the Farm Service Agency (FSA) is requesting comments from all interested individuals and organizations on an extension with a revision of a currently approved information collection request associated with the Food Safety Certification for Specialty Crops (FSCSC) program....

The Food and Drug Administration (FDA or Agency) has determined that HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 milliliters (mL); HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 mL; HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 10,000 units/100 mL; and HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLOR...

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 c...

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Animal Studies for Dental Bone Grafting Material Devices--Premarket Notification (510(k)) Submissions." This guidance document provides recommendations for animal study design and animal study information to include to support a 510(k) submission for dental bone grafting material devices. This guidance may help manufacturers comply with some special controls for dental bone grafting mate...

The Food and Drug Administration (FDA, Agency, or we) is classifying the menopause test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the menopause test system. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action wil...

The Food and Drug Administration (FDA, the Agency, or we) is classifying the pharmacogenetic assessment system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the pharmacogenetic assessment system. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device...

The Food and Drug Administration (FDA, the Agency, or we) is classifying the laparoscopic gastrointestinal sizing tool into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the classification of the laparoscopic gastrointestinal sizing tool. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effecti...

The Food and Drug Administration (FDA, the Agency, or we) is classifying the mutation detection test for myeloproliferative neoplasms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the mutation detection test for myeloproliferative neoplasms. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assur...

The Food and Drug Administration (FDA, the Agency, or we) is classifying the liver iron concentration imaging companion diagnostic for deferasirox into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the liver iron concentration imaging companion diagnostic for deferasirox. We are taking this action because we have determined that classifying the device into class II will ...

The Food and Drug Administration (FDA, the Agency, or we) is classifying the anti-phospholipase A2 receptor immunological test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the anti-phospholipase A2 receptor immunological test system's classification. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assura...

The Food and Drug Administration (FDA, the Agency, or we) is classifying orthopedic manual surgical instrumentation for use with total disc replacement devices into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of orthopedic manual surgical instrumentation for use with total disc replacement devices. We are taking this action because we have determined that classifying the ...

The Food and Drug Administration (FDA, the Agency, or we) is classifying the postnatal chromosomal copy number variation detection system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the postnatal chromosomal copy number variation detection system's classification. We are taking this action because we have determined that classifying the device into class II will provide a reasonabl...

The Food and Drug Administration (FDA, the Agency, or we) is classifying orthopedic manual surgical instrumentation for use with non-fusion spinous process spacer devices into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of orthopedic manual surgical instrumentation for use with non-fusion spinous process spacer devices. We are taking this action because we have determined...

The Food and Drug Administration (FDA, the Agency, or we) is classifying the device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis's classification. We are taking t...

The Food and Drug Administration (FDA, the Agency, or we) is classifying the cancer predisposition risk assessment system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the cancer predisposition risk assessment system. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effec...

The Food and Drug Administration (FDA or Agency) has determined that RIFADIN (rifampin) capsules, 150 milligrams (mg) and 300 mg, were not withdrawn from sale for reasons of safety or effectiveness to the extent that the drugs can be manufactured or formulated in a manner that satisfies any applicable acceptable intake limit for nitrosamine impurities. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Approaches to Assessment of Overall Survival in Oncology Clinical Trials." The purpose of this draft guidance is to provide recommendations to sponsors on the assessment of overall survival in randomized oncology clinical trials conducted to support marketing approval of drugs and biological products, with an emphasis on the analysis of overall survival as a prespecified saf...

The Food and Drug Administration is proposing to extend the compliance date for the final rule, "Requirements for Additional Traceability Records for Certain Foods," due to concerns about the amount of time affected entities will need to implement the requirements of the rule. If finalized, this rule would extend the compliance date by 30 months from January 20, 2026, to July 20, 2028....

The Food and Drug Administration (FDA or Agency) has determined that ROXICET (oxycodone hydrochloride (HCl) and acetaminophen) tablet, 5 milligrams (mg)/325 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for oxycodone HCl and acetaminophen tablet, 5 mg/ 325 mg, if all other legal and regulatory requirements are met....

The Food and Drug Administration (FDA or Agency) has determined that HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (heparin sodium) injectable, 200 units/100 milliliters (mL); HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (heparin sodium) injectable, 200 units/100 mL; and HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (heparin sodium) injectable, 1,000 units/100 mL under new drug application (NDA) 019042 were not withdr...

The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2026 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA)....

The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2026 annual fee rate for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) that is authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). This fee is effective on August 1, 2025, and will remain in effect through September 30, 2026....

The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2026 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). We are also announcing the fee rate for certification bodies applying ...

In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed information collection. This collection is a revision of a currently approved collection for the mandatory collection of summer meal site information from State agencies....

The Food and Drug Administration (FDA or we) is proposing to revoke 23 standards of identity for food. FDA is taking this action because we tentatively conclude that these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This proposed action would reduce redundant regulatory requirements....

The Food and Drug Administration (FDA or we) revokes 11 food standards for foods that are no longer sold in the United States. FDA is taking this action as these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This action will remove obsolete rules to reduce unnecessary regulatory requirements....

The Food and Drug Administration (FDA or we) is proposing to revoke 11 food standards for foods that are no longer sold in the United States. FDA is taking this action as we tentatively conclude these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This action, if finalized, will remove obsolete rules to possibly reduce unnecessary regulatory requirements....

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of gardenia (genipin) blue in various foods, at levels consistent with good manufacturing practice (GMP). We are taking this action in response to a color additive petition (CAP) submitted by Exponent, Inc., on behalf of the Gardenia Blue Interest Group (GBIG)....

The Food and Drug Administration (FDA, Agency, or we) has determined that SYNDROS (dronabinol) solution, 5 milligrams (mg)/ milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for SYNDROS (dronabinol) solution, 5 mg/ mL, if all other legal and regulatory requirements are met....

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, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Emerging Drug Safety Technology Meeting (EDSTM) Program....

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solic...

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 c...

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 c...

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 c...

The Food and Drug Administration (FDA or the Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled "Modifications to the List of Recognized Standards, Recognition List Number: 064" (Recognition List Number: 064), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical d...

The Food and Drug Administration (FDA, the Agency, or we) is classifying the cream for x-ray attenuation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the cream for x-ray attenuation's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the ...

The Food and Drug Administration (FDA, the Agency, or we) is classifying the muscular dystrophy newborn screening test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the muscular dystrophy newborn screening test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safe...

The Food and Drug Administration (FDA, the Agency, or we) is classifying the lysosomal storage disorder newborn screening test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the lysosomal storage disorder newborn screening test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide ...

The Food and Drug Administration (FDA, the Agency, or we) is classifying the herpes simplex virus nucleic acid-based assay for central nervous system infections into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the herpes simplex virus nucleic acid-based assay for central nervous system infections. We are taking this action because we have determined that classifying th...

The Food and Drug Administration (FDA, the Agency, or we) is classifying the fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies' classifica...

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.

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 c...

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled "Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population." The purpose of the hybrid public meeting is to seek public input on the clinical use and safety concerns associated with the use of orally ingestible unapproved prescription drug products containing fluoride in the pediatric population. The public meeting will be facilitated ...

The Food and Drug Administration (FDA, the Agency, or we) is classifying the radiological computer-assisted detection and diagnosis software into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the radiological computer-assisted detection and diagnosis software's classification. We are taking this action because we have determined that classifying the device into class II (special controls)...

The Food and Drug Administration (FDA, the Agency, or we) is classifying the cellular analysis system for multiplexed antimicrobial susceptibility testing into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the cellular analysis system for multiplexed antimicrobial susceptibility testing's classification. We are taking this action because we have determined that classifying the device into...

The Food and Drug Administration (FDA, the Agency, or we) is classifying the clinical mass spectrometry microorganism identification and differentiation system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the clinical mass spectrometry microorganism identification and differentiation system's classification. We are taking this action because we have determined that classifying the d...

The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect and identify fungal nucleic acids directly in respiratory specimens into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify fungal nucleic acids directly in respiratory specimens' classification. We are taking this action because we have determined that classifying the de...

The Food and Drug Administration (FDA) is proposing to reclassify in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation, along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety an...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #287 entitled "Raw Data for Safety and Effectiveness Studies." This guidance provides information to animal drug sponsors (sponsors) on the use of raw data in the Center for Veterinary Medicine's (CVM) review of safety and effectiveness studies submitted in support of new animal drug applications. This guidance also describes our recommendations for submitting raw data....

The Food and Drug Administration (FDA or Agency) has determined that EPINEPHRINE (epinephrine) solution, 1 milligram (mg)/ milliliter (mL), prefilled syringe for intravenous use, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they m...

The Food and Drug Administration (FDA, the Agency, or we) is classifying the radiological acquisition and/or optimization guidance system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the radiological acquisition and/or optimization guidance system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will ...

The Food and Drug Administration (FDA, the Agency, or we) is classifying the device to detect bacterial protease activity in chronic wound fluid into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect bacterial protease activity in chronic wound fluid's classification. We are taking this action because we have determined that classifying the device into class II (special c...

The Food and Drug Administration (FDA or Agency) has determined that ACTIGALL (ursodiol) capsule, 150 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ursodiol capsule, 150 mg, if all other legal and regulatory requirements are met....

The Food and Drug Administration (FDA, Agency, or we) has determined that COREG CR (carvedilol phosphate) extended-release capsules, 10 milligrams (mg), 20 mg, 40 mg, and 80 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they m...

The Food and Drug Administration (FDA, the Agency, or we) is classifying the anti-mullerian hormone test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the anti-mullerian hormone test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effecti...

The Food and Drug Administration (FDA or we) is reopening the comment period for a draft guidance entitled "Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event: Guidance for Industry," which was announced in the Federal Register of January 7, 2025. We are taking this action in response to requests to allow interested persons additional time to submit comments before FDA begins work on the final guidance...

The Food and Drug Administration (FDA, Agency, or we) is classifying the plazomicin test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the plazomicin test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We bel...

The Food and Drug Administration (FDA, Agency, or we) is classifying the Zika virus serological reagents into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the Zika virus serological reagents' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of t...

The Food and Drug Administration (FDA, Agency, or we) is classifying the inherited nucleotide repeat disorder DNA test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the inherited nucleotide repeat disorder DNA test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of ...

The Food and Drug Administration (FDA, Agency, or we) is classifying the temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the temporarily- placed urethral opening system for symptoms of benign prostatic hyperplasia's classification. We are taking this action because we have determined that classifyin...

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 zinc L- selenomethionine as a source of selenium in complete feed for broiler chickens. This action is in response to a food additive petition filed by Zinpro Corp....

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements....

The Food and Drug Administration (FDA, Agency, or we) is classifying the voriconazole test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the voriconazole test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We...

The Food and Drug Administration (FDA, Agency, or we) is classifying the breast milk macronutrients test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the breast milk macronutrients test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and eff...

The Food and Drug Administration (FDA, Agency, or we) is classifying the microbial nucleic acid storage and stabilization device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the microbial nucleic acid storage and stabilization device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reas...

The Food and Drug Administration (FDA, Agency, or we) is classifying the cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection's classification. We are taking this action because we have determined that classifying t...

The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect and identify microbial nucleic acids by fluorescence in situ hybridization (FISH) in clinical specimens into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microbial nucleic acids by FISH in clinical specimens classification. We are taking this action because we have ...

The Food and Drug Administration (FDA, Agency, or we) is classifying the DNA-based test to measure minimal residual disease in hematological malignancies into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the DNA-based test to measure minimal residual disease in hematological malignancies classification. We are taking this action because we have determined that classifying the device into...

The Food and Drug Administration (FDA, Agency, or we) is classifying the coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients' classification. We are taking this action because we h...

The Food and Drug Administration (FDA, Agency, or we) 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.

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 c...

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 (PRA).

The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket for public comments exploring the Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) for submission of data collected from real-world data (RWD) sources. In alignment with the new Department of Health and Human Services (HHS), Assistant Secretary for Technology Policy/Office of the National Coordinator for Health (ASTP/ONC) policy on health information technology (health IT), ...

The Food and Drug Administration (FDA or Agency) has determined that MOBIC (meloxicam) tablets, 7.5 milligrams (mg) and 15 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements....

The Food and Drug Administration (FDA) is announcing an amendment to the notice of joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. This meeting was announced in the Federal Register of December 9, 2024. The amendment is being made to reflect changes in the DATES, ADDRESSES, and Procedure portions of the document. There are no other changes....

FMCSA announces its final decision to renew the exemption granted to McKee Foods Transportation, LLC (MFT), USDOT #1025678, from the hours-of-service (HOS) regulations pertaining to the use of a sleeper berth. The exemption renewal allows MFT team drivers to take the equivalent of 10 consecutive hours off duty by splitting sleeper berth time into two periods totaling 10 hours, provided neither of the two periods is less than two hours. FMCSA has analyzed the exemption application and the public ...

The Food and Drug Administration (FDA, the Agency, or we) has determined that ETHYOL (amifostine) for injection, 500 milligrams (mg)/ vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requi...

The Food and Drug Administration (FDA, the Agency, or we) has determined that FLUMADINE (rimantadine hydrochloride) tablet, 100 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory ...

The Food and Drug Administration (FDA, Agency, or we) has determined that NASCOBAL (cyanocobalamin) nasal spray, 0.5 milligram (mg)/spray, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requir...

The Food and Drug Administration (FDA, Agency, or we) has determined that DECADRON (dexamethasone sodium phosphate) solution/ drops, equivalent to (EQ) 0.1 percent phosphate, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet ...

The Food and Drug Administration (FDA, Agency, or we) has determined that VIBRAMYCIN (doxycycline) for oral suspension, equivalent (EQ) 25 milligrams (mg) base/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they ...

The U.S. Codex Office is sponsoring a public meeting on May 29, 2025. The objective of the public meeting is to provide information and receive public comments on agenda items to be discussed at the 18th Session of the Codex Committee on Contaminants in Foods (CCCF18) of the Codex Alimentarius Commission (CAC). CCCF18 will be held in Bangkok, Thailand, from June 23-27, 2025. The U.S. Manager for Codex Alimentarius and the Under Secretary for Trade and Foreign Agricultural Affairs recognize the i...

The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled "Modifications to the List of Recognized Standards, Recognition List Number: 063" (Recognition List Number: 063), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devic...

The Food and Drug Administration (FDA or Agency) has determined that RIOMET (metformin hydrochloride) Oral Solution, 500 milligrams (mg)/5 milliliters (mL) has not been withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal...

The Alcohol and Tobacco Tax and Trade Bureau (TTB) proposes to require a labeling disclosure of all major food allergens used in the production of alcohol beverages subject to TTB's regulatory authority under the Federal Alcohol Administration Act. Under the proposed regulations, unless an exception applies, labels must declare milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame, as well as ingredients that contain protein derived from these foods, if used in ...

The Food and Drug Administration (FDA, the Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice s...

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Optimizing Pregnancy Registries." The purpose of the public workshop is to discuss challenges in designing and implementing pregnancy registries and to consider innovative approaches to improve the design and conduct of pregnancy registries to inform the safety of drug and biological products during pregnancy. This public workshop is being held in collaboration with the University of M...

The Food and Drug Administration (FDA or we) proposes to require front-of-package nutrition labels on most foods that must bear a Nutrition Facts label. This action, if finalized, would require the display of a compact informational box containing certain nutrient information on the principal display panel. The box would provide consumers, including those who have lower nutrition knowledge, with standardized, interpretive nutrition information that can help them quickly and easily identify how f...

The Food and Drug Administration (FDA or we) is granting a color additive petition submitted by Center for Science in the Public Interest, et al., by repealing the color additive regulations that permit the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs. The petitioners provided data demonstrating that this additive induces cancer in male rats. Therefore, FDA is revoking the authorized uses in food and ingested drugs of FD&C Red No. 3 in the color additive r...

The Food and Drug Administration (FDA, the Agency, or we) is soliciting comments from the public, particularly veterinarians, related to the use of cannabis-derived products (CDPs) in animals, with an emphasis on cannabidiol (CBD) products and general trends associated with those products, including information about: usage trends (e.g., product selection, indications, etc.), quality standards, benefits of use, potential drug interactions, adverse events and safety problems, and toxicological co...

This document proposes a voluntary framework for the evaluation and oversight of motor vehicles equipped with automated driving systems (ADS). The ADS-equipped Vehicle Safety, Transparency, and Evaluation Program (AV STEP) would establish a national program for ADS-equipped vehicles that operate or may operate on public roads in the United States under NHTSA's oversight with the goal of improving public transparency related to the safety of certain ADS-equipped vehicles, while allowing for respo...

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) in the Center for Devices and Radiological Health. Nominations will be accepted for current and upcoming vacancies effective January 1, 2025, with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees a...

The Food and Drug Administration (FDA or we) is announcing the availability of a revised final guidance for industry entitled "Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry." The guidance explains FDA's current thinking on a number of issues related to the labeling of food allergens, including requirements in the Food Allergen Labeling and Consumer Protection Act of ...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry #294 entitled "Animal Food Ingredient Consultation (AFIC)." This guidance describes FDA's interim AFIC process and explains one way FDA will work with firms that are developing animal food ingredients now that the Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO) expired on October 1, 2024, and while FDA evaluates the animal Food Additiv...

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for FDA staff and interested parties entitled "Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act." This guidance document provides our current thinking on the approach we generally intend to take when we evaluate the public health importance of a food allergen other than one of the major food allergens (i.e....

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "Action Levels for Lead in Processed Food Intended for Babies and Young Children." The guidance establishes action levels for lead in certain processed foods intended for babies and young children less than 2 years old. The guidance is intended to set achievable action levels that will help further reduce lead in the food supply....

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event." The draft guidance, when finalized, will explain FDA's current thinking on establishing a routine sanitation program for low-moisture ready-to-eat human foods (LMRTE foods) that can help prevent contamination of food or ...

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Artificial Intelligence Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations." This draft guidance, when finalized, will provide recommendations regarding the contents of marketing submissions for devices that include artificial intelligence (AI)-enabled device software functions including documentation and information that will support FDA's...

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Evaluation of Sex- Specific and Gender-Specific Data in Medical Device Clinical Studies." This document provides guidance on the study and evaluation of sex- and/or gender-specific data in clinical investigations or research involving one or more subjects to determine the safety or effectiveness of a device. The purpose of this guidance is to encourage science- driven consideration of ...

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #251 entitled "Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease." This draft guidance, when finalized, will set forth FDA's policy regarding heritable intentional genomic alterations (IGAs) in animals of food- producing species, such as swine and rabbits, that are intended to be marketed for use as models of human o...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act." This guidance describes FDA's interim policy concerning compounding by human drug product compounders that are not outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under ...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act." This guidance describes FDA's interim regulatory policy concerning compounding by outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that outsourcing facilities can use in compounding under the applicable...

The Food and Drug Administration (FDA or we) is announcing its determination that the Food Contact Notifications (FCNs) listed in this notice are no longer effective. Several manufacturers notified FDA in writing that they ceased producing, supplying, or using the listed food contact substances (FCSs) for their intended use in the United States. We are taking this action in accordance with the process set out in our regulations, by which FDA may determine that an FCN is no longer effective....

The Food and Drug Administration (FDA or we) is issuing this final rule updating the definition for the implied nutrient content claim "healthy" to be consistent with current nutrition science and Federal dietary guidance, especially the Dietary Guidelines for Americans (Dietary Guidelines), regarding how consumers can maintain healthy dietary practices. This final rule revises the requirements for when the term "healthy" can be used as an implied nutrient content claim in the labeling of human ...

The Food and Nutrition Service is correcting a final rule that appeared in the Federal Register on October 31, 2024. The document makes access and parity improvements in USDA's food distribution programs to support access for eligible populations and streamline requirements for program operators.

The United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) is amending the USDA organic regulations to clarify standards for organic mushrooms and organic pet food. The topics addressed by the rule include mushroom substrate composition and sourcing of mushroom spawn in organic mushroom production, composting requirements for organic mushroom production, composition and labeling requirements for organic pet food, and the use of certain synthetic substances, including...

Pursuant to the provisions of the rules and regulations of the USDA and the Federal Advisory Committee Act (FACA), the USDA is soliciting nominations for membership on the National Advisory Committee on Microbiological Criteria for Foods (NACMCF)and announcing potential charges for the 2025-2027 term. USDA seeks to appoint 30 members. Advisory Committee members serve a two-year term beginning September 2025 through September 2027. Members may be reappointed for one additional consecutive term at...

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Safety and Occupational Health Study Section (SOHSS). SOHSS consists of 20 experts in fields associated with occupational medicine and nursing, industrial hygiene, occupational safety and engineering, toxicology, chemistry, safety and health education, ergonomics, epidemiology, economic ...

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solic...

The Food and Drug Administration (FDA or we) 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.

The Food and Drug Administration (FDA, us, or we) 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.

The Food and Drug Administration (FDA or the Agency) is announcing the renewal of the Science Board to the Food and Drug Administration by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Science Board to the Food and Drug Administration for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the June 26, 2026, expiration date....

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee (the Committees). The general function of the Committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document....

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements....

This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by South32 Hermosa Inc.

FSIS and FDA (we, the agencies) are seeking public input on food date labeling. This Request for Information seeks information on industry practices and preferences for date labeling, research results on consumer perceptions of date labeling, and any impact date labeling may have on food waste.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft revised guidance for industry (GFI) #49 entitled "Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis." This draft guidance provides recommendations and considerations for bovine mastitis drug products with antibacterial activity that are administered by intramammary infusion....

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions." This guidance demonstrates FDA's commitment to developing innovative approaches to the regulation of artificial intelligence (AI)-enabled devices. More specifically, this guidance provides recommendations on the information to include in a Pred...

The Food and Nutrition Service (FNS) is proposing changes to Supplemental Nutrition Assistance Program (SNAP) regulations in accordance with the Food and Nutrition Act of 2008, which calls for a cost adjustment in the Thrifty Food Plan (TFP) for Hawaii to reflect the cost of food in Hawaii. The proposal would update the method for calculating this cost adjustment to incorporate food prices from throughout the State of Hawaii rather than from Honolulu alone, ensuring that SNAP benefit allotments ...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled "Food and Drug Administration Report and Plan on Best Practices for Guidance" (Report and Plan). FDA is publishing this Report and Plan in response to the Consolidated Appropriations Act, 2023, which directs FDA to issue a report identifying best practices for the efficient prioritization, development, issuance, and use of guidance documents and a plan for implementation of such best practices....

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Safety and Occupational Health Study Section (SOHSS). SOHSS consists of 20 experts in fields associated with occupational medicine and nursing, industrial hygiene, occupational safety and engineering, toxicology, chemistry, safety and health education, ergonomics, epidemiology, economic ...

FSIS is establishing January 1, 2028, as the uniform compliance date for new meat and poultry product labeling regulations that will be issued between January 1, 2025, and December 31, 2026. FSIS periodically announces uniform compliance dates for new meat and poultry product labeling regulations to minimize the economic impact of label changes....

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Orthopedic Non-Spinal Bone Plates, Screws, and Washers--Premarket Notification (510(k)) Submissions." This guidance document provides recommendations for information to include in 510(k) submissions for non-resorbable bone plate, screw, and washer devices. The scope of this guidance includes devices that are indicated for orthopedic bone fixation but does not include devices indicated fo...

The Food and Drug Administration (FDA or Agency) has determined that IC-GREEN (indocyanine green), 25 milligrams (mg)/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for IC-GREEN (indocyanine green), 25 mg/vial, if all other legal and regulatory requirements are met....

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on October 16, 2024. The document announced that NOXAFIL (posaconazole) delayed-release tablets, 100 grams (g), was not withdrawn from sale for reasons of safety or effectiveness. The document incorrectly listed the dosage strength as 100 g. The correct strength is 100 milligrams (mg). This notice corrects that error....

The Food and Drug Administration (FDA or Agency) has determined that FORTESTA (testosterone) gel, 10 milligrams (mg)/0.5 gram (gm) actuation, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory req...

The Consumer Product Safety Improvement Act of 2008 (CPSIA) mandates that ASTM F963 shall be a mandatory toy safety standard. This toy safety standard sets forth only minimal labeling requirements for aquatic toys such as neck floats. The U.S. Consumer Product Safety Commission (CPSC or Commission) proposes to establish new performance and revised labeling requirements to address potentially deadly hazards associated with neck floats. The Commission also proposes to amend CPSC's list of notice o...

The Food and Drug Administration (FDA or Agency) has determined that HYDROCORTONE (hydrocortisone sodium phosphate) injection, equivalent to (EQ) 50 milligrams (mg) base/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for HYDROCORTONE (hydrocortisone sodium phosphate) injection, EQ 50 mg base/mL, if all other legal and regulatory requirements are met....

The Food and Drug Administration (FDA, Agency, or we) has determined that JESDUVROQ (daprodustat) tablets, 1 milligram (mg), 2 mg, 4 mg, 6 mg, and 8 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for JESDUVROQ (daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg, if all other legal and regulatory requirements are met....

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics." FDA is publishing this draft guidance which, when finalized, will provide recommendations on approaches for the nonclinical safety evaluation of oligonucleotide-based therapeutics (ONTs) to support clinical development and marketing of these products. ONTs present unique challenges and opportunities in the...

The Food and Drug Administration (FDA or Agency) has determined that NUPLAZID (pimavanserin tartrate) tablet, equivalent (EQ) 17 milligram (mg) base, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for NUPLAZID (pimavanserin tartrate) tablet, EQ 17 mg base, if all other legal and regulatory requirements are met....

The Danny Keysar Child Product Safety Notification Act, section 104 of the Consumer Product Safety Improvement Act of 2008 (CPSIA), requires the U.S. Consumer Product Safety Commission (Commission or CPSC) to promulgate consumer product safety standards for durable infant or toddler products. Under this statutory authority, the Commission is issuing a safety standard for infant support cushions. The Commission is also amending CPSC's consumer registration requirements to identify infant support ...

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for FDA staff entitled "Sec. 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products--Decomposition and Histamine (CPG 7108.24) Compliance Policy Guide." This compliance policy guide (CPG) is intended to provide FDA staff guidance on adulteration associated with decomposition and/or histamine identified during surveillance sampling and testing of fish and fishery products susce...

This final rule considers public comments submitted in response to the proposed rule revising the Commodity Supplemental Food Program (CSFP), the Food Distribution Program on Indian Reservations (FDPIR), The Emergency Food Assistance Program (TEFAP), and USDA Foods disaster response regulations. This final rule makes access and parity improvements in USDA's food distribution programs to support access for eligible populations and streamline requirements for program operators....

The Food and Drug Administration (FDA or we) is responding to the objection that we received from the Environmental Defense Fund, Breast Cancer Prevention Partners, Environmental Protection Network, Environmental Working Group, and Healthy Babies Bright Futures on the final rule that amended the food additive regulations to no longer provide for the use of 25 plasticizers that the petition identified as ortho-phthalates because these food additive uses have been permanently abandoned. After revi...

The Food and Drug Administration (FDA or we) received objections and requests for a public hearing submitted by the Environmental Defense Fund, Learning Disabilities Association of America, Center for Food Safety, Center for Environmental Health, Center for Science in the Public Interest, Breast Cancer Prevention Partners, Defend our Health, and Alaska Community Action on Toxics on the denial of a food additive petition (FAP 6B4815) requesting that we revoke specified regulations to no longer pr...

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.

FMCSA announces its decision to renew an exemption requested by the Agricultural and Food Transporters Conference (AFTC) of American Trucking Associations (ATA), which will allow certain alternative methods for the securement of agricultural commodities transported in wood and plastic boxes and bins and large fiberglass tubs, as well as hay, straw, and cotton bales that are grouped together into large singular units. FMCSA concludes that renewing the exemption, subject to the terms and condition...

FMCSA reopens the comment period for its July 10, 2024, notice requesting public comment on an application from McKee Foods Transportation, LLC (MFT) for a renewal of its exemption from the hours-of-service regulation pertaining to the use of a sleeper berth. FMCSA has added a supplemental document to the docket titled "McKee Foods Transportation Sleeper-Berth Exemption Provisions Interpretation." FMCSA reopens the comment period to allow the public an opportunity to review MFT's application for...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Guidance for Industry." This guidance is intended to provide a framework for considering whether and what type of long-term neurologic, sensory, and developmental evaluations could be useful in supporting a determination of safety of an FDA-regulated "medical product" (i....

The Food and Drug Administration (FDA, Agency, or we) has determined that TAVIST (clemastine fumarate) tablet, 2.68 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements...

The Food and Drug Administration (FDA, Agency, or we) has determined that NOXAFIL (posaconazole) delayed-release tablets, 100 grams (g), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirem...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Endosseous Dental Implants and Endosseous Dental Implant Abutments--Performance Criteria for Safety and Performance Based Pathway." The device-specific guidance identified in this notice was developed in accordance with the finalized guidance entitled "Safety and Performance Based Pathway." This guidance has been implemented without prior comment, but it remains subject to comment in acc...

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry #284 entitled "Using Relative Supersaturation To Support `Urinary Tract Health' Claims for Adult Maintenance Cat Food." FDA's Center for Veterinary Medicine (CVM) has evaluated the use of relative supersaturation (RSS) methodology to support urinary tract health claims for certain adult maintenance cat food. RSS is a measurement that estimates the potential for crystal formation ...

This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by Northern Star (Pogo), LLC.

The Food and Drug Administration (FDA, Agency, or we) has determined that AUGMENTIN XR (amoxicillin; clavulanate potassium) Extended-Release Tablets, 1 gram (gm); equivalent to (EQ) 62.5 milligram (mg) base, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for AUGMENTIN XR (amoxicillin; clavulanate potassium) Extended-Release Tablets, 1 gm; EQ 62.5 mg base, if all other legal and regulatory ...

The Food and Drug Administration (FDA or Agency) is announcing the availability of four final device-specific guidance documents for the Safety and Performance Based Pathway--specifically, "Air Powered Dental Handpieces and Air Motors--Performance Criteria for Safety and Performance Based Pathway," "Dental Ceramics--Performance Criteria for Safety and Performance Based Pathway," "Dental Impression Materials--Performance Criteria for Safety and Performance Based Pathway," and "Dental Cements--Per...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft revised guidance for industry (GFI) #116 (VICH GL23) entitled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2)." This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft guidance recommends a Standar...

The Food and Drug Administration (FDA or we) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 2A4832) proposing that the food additive regulations for chlorine dioxide be amended to provide for an additional method for producing the additive.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation: Small Entity Compliance Guide." We are updating the small entity compliance guide (SECG) to help small entities comply with revised requirements related to agricultural water in the "Standards for the Growing, Harvesting, Packing, a...

The Food and Drug Administration (FDA or Agency) is announcing the availability of three draft guidance documents for the Accreditation Scheme for Conformity Assessment Program entitled "The Accreditation Scheme for Conformity Assessment (ASCA) Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff;" "Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment--Standards Specific Informati...

The Food and Drug Administration (FDA, Agency, or we) is proposing to amend the Scope section of our regulation that provides for a regulatory hearing before the Agency to clarify when such hearings are available. We are proposing to revise the list of statutory provisions enumerated in the Scope section of the regulation by removing one statutory reference and adding a different statutory reference....

The Food and Drug Administration (FDA, Agency, or we) is issuing a direct final rule amending the Scope section of our regulation that provides for a regulatory hearing before the Agency in order to clarify when such hearings are available. We are revising the list of statutory provisions enumerated in the Scope section of the regulation by adding one statutory reference and removing a different statutory reference. The Agency is issuing these amendments directly as a final rule because we belie...

CDC has modified its structure. This notice announces the reorganization of the Office of Laboratory Science and Safety (OLSS). OLSS was retitled to the Office of Laboratory Systems and Response (OLSR) and additional organizational updates were approved.

This final rule amends the Federal Manufactured Home Construction and Safety Standards (MHCSS or the Construction and Safety Standards) by adopting most of the fourth and fifth groups of recommendations made to HUD by the Manufactured Housing Consensus Committee (MHCC). This rule also amends the Manufactured Home Procedural and Enforcement Regulations, the Model Manufactured Home Installation Standards, and the Manufactured Home Installation Program regulations. The MHCC prepared and submitted t...

The Consumer Product Safety Improvement Act of 2008 (CPSIA) mandates that ASTM F963 shall be a mandatory toy safety standard. This safety standard sets forth requirements for water bead toys and toys that contain water beads. The U.S. Consumer Product Safety Commission (CPSC) proposes to establish additional performance and labeling requirements for these products. The Commission also proposes to amend CPSC's list of notice of requirements (NORs) to include water bead toys and toys that contain ...

The Food and Drug Administration (FDA or Agency) has determined that FLAGYL (metronidazole) tablets, 250 milligrams (mg) and 500 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requir...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers." This final guidance document is intended to help manufacturers better understand and use the VMSR Program. This guidance describes and clarifies several aspects of the VMSR Program, including the FDA's approach to determining the eligibility of product codes for the program and the conditions for submitting medica...

This notice is announcing that the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) will hold a public meeting of the full Committee and Subcommittees from September 24, 2024, to September 26, 2024. The Committee will provide updates on FSIS' Genomics charge and the U.S. Food and Drug Administration's (FDA's) Cronobacter spp. in Powdered Infant Formula charge....

The Food and Drug Administration (FDA or Agency) has determined that FENTANYL CITRATE Injections, equivalent to 2.5 milligram (mg) base/50 milliliter (mL) (EQ 0.05 mg base/mL) and EQ 5 mg base/100 mL (EQ 0.05 mg base/mL), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for FENTANYL CITRATE Injections, EQ 2.5 mg base/50 mL (EQ 0.05 mg base/mL) and EQ 5 mg base/100 mL (EQ 0.05 mg base/mL), i...

The Food and Drug Administration (FDA or the Agency) has determined that DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% (diltiazem hydrochloride (HCl)), 125 milligrams (mg)/125 milliliters (mL) (1 mg/ mL) and 250 mg/250 mL (1 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for diltiazem HCl, 125 mg/125 mL (1 mg/mL) and 250 mg/250 mL (1 mg/mL), if all other legal and regulatory requirements ...

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Predetermined Change Control Plans for Medical Devices." A predetermined change control plan (PCCP) is the documentation describing what modifications will be made to a device and how the modifications will be assessed. This draft guidance provides FDA's current thinking on a policy for PCCPs and recommendations on the information to include in a PCCP in a marketing submission for a de...

The Food and Drug Administration (FDA, Agency, or we) has determined that PENNSAID (diclofenac sodium) Topical Solution 2%, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements....

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2)." The draft guidance, when finalized, will describe our views on the next voluntary goals (Phase II (3-year)) for sodium reduction in a variety of identified categories of foods that are commercially processed, packaged, or p...

The Food and Drug Administration, with the Department of the Treasury's concurrence, proposes amending its regulations to require that the Submission Tracking Number for Electronic Nicotine Delivery System tobacco products that are being imported or offered for import be submitted in the Automated Commercial Environment or any other electronic data interchange system authorized by U.S. Customs and Border Protection, at the time of entry....

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 c...

The Food and Drug Administration (FDA or we) is announcing the following public meeting entitled "Development of an Enhanced Systematic Process for FDA's Post-Market Assessment of Chemicals in Food." This public meeting will assist in developing the post-market chemicals assessment program we will establish under the new FDA Human Foods Program. The purpose of the public meeting is to hear from interested parties about approaches to systematic post-market assessment of chemicals in food....

The U.S. Codex Office is sponsoring a public meeting on October 1, 2024. The objective of the public meeting is to provide information and receive public comments on agenda items and draft U.S. positions to be discussed at the 27th Session of the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) of the Codex Alimentarius Commission (CAC), which will meet in Omaha, Nebraska, from October 21-25, 2024. The U.S. Manager for Codex Alimentarius and the Under Secretary for Trade and For...

The Food and Drug Administration (FDA) is announcing the withdrawal of a notice that was published in the Federal Register of August 2, 2024.

The Food and Drug Administration (FDA or Agency) is announcing the availability of draft guidance for industry #294 entitled "Animal Food Ingredient Consultation (AFIC)." This draft guidance describes FDA's interim AFIC process and explains one way FDA intends to work with firms that are developing animal food ingredients after the Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO) expires on October 1, 2024, and while FDA evaluates the animal Food ...

The Food and Drug Administration (FDA, we, or Agency) is soliciting comments from the public regarding the Food Additive Petition and Generally Recognized as Safe (GRAS) Notification programs to determine if changes are needed to promote their efficiency. Specific questions and information requests are included in this notice to help guide input from stakeholders and other members of the public....

The U.S. Codex Office is sponsoring a public meeting on October 9, 2024. The objective of the public meeting is to provide information and receive public comments on agenda items and draft U.S. positions to be discussed at the 48th Session of the Codex Committee on Food Labelling (CCFL48) of the Codex Alimentarius Commission (CAC). CCFL48 will be held in Quebec City, Canada, from October 27-November 1, 2024. The U.S. Manager for Codex Alimentarius and the Under Secretary for Trade and Foreign Ag...

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Drug Safety and Risk Management Advisory Committee and the Psychopharmacologic Drugs Advisory Committee (the Committees). The general function of the Committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document....

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #293 entitled "FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients." This draft guidance, when finalized, will communicate FDA's enforcement policy regarding ingredients listed in chapter six of the 2024 Association of American Feed Control Officials (AAFCO) Official Publication (OP) after the expiration of the Agency's memorandum of understanding (MOU) with AA...

The Food and Drug Administration (FDA or Agency) has determined that CIPRO (ciprofloxacin hydrochloride (HCl)) tablet, equivalent to (EQ) 100 milligrams (mg) base, was withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for ciprofloxacin HCl tablet, EQ 100 mg base....

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements....

The Food and Drug Administration (FDA or the Agency) is announcing the renewal of the Drug Safety and Risk Management 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 Drug Safety and Risk Management Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the May 31, 2026, expiration date....

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 a notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed study entitled "Risk/Safety Considerations and Motiva...

The Food and Drug Administration (FDA or Agency) is announcing the fiscal year (FY) 2025 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA)....

The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2025 annual fee rate for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) that is authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). This fee is effective on August 1, 2024, and will remain in effect through September 30, 2025....

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed reinstatement of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice s...

The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2025 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program that is authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). We are also announcing the fee rate for certification bodies t...

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 c...

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.

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.

The Food and Drug Administration (FDA or we) is reopening the comment period for the notification of petition, published in the Federal Register of April 26, 2024, announcing that we have filed a food additive petition, submitted by Environmental Defense Fund, et al., proposing that the food additive regulations be amended to remove fluorinated polyethylene. FDA is reopening the comment period to add the food additive petition to the docket. FDA is also making a correction to the filing notice....

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #100 (VICH GL 18(R2)) entitled "Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2)." This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The objective of this guidance is to recommend ...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder." Design of clinical studies for devices intended to treat opioid use disorder (OUD) is challenging. To help spur innovative options to combat the opioid overdose crisis and treat OUD, this guidance provides recommendations on the design of pivotal clinical studies for devices intended to treat OUD (OUD ...

The U.S. Codex Office is sponsoring a public meeting on August 21, 2024. The objective of the public meeting is to provide information and receive public comments on agenda items and draft U.S. positions to be discussed at the 27th Session of the Codex Committee on Food Import and Export Inspection and Certification Systems (CCFICS) of the Codex Alimentarius Commission (CAC). The 27th Session of the CCFICS will be held in Cairns, Australia, from September 16-20, 2024. The U.S. Manager for Codex ...

FMCSA announces that it has received an application from McKee Foods Transportation, LLC (MFT) for a renewal of its exemption from the hours-of-service regulation pertaining to the use of a sleeper berth. The exemption renewal would allow MFT team drivers to continue taking the equivalent of 10 consecutive hours off duty by splitting sleeper berth time into two periods totaling 10 hours, provided neither of the two periods is less than three hours. MFT currently holds an exemption for the period...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance outlines general principles on planning...

The Food and Drug Administration (FDA or we) is amending our regulations to revoke the authorization for the use of brominated vegetable oil (BVO) in food. This action is being taken because there is no longer a reasonable certainty of no harm from the continued use of BVO in food. Specifically, the final rule revokes the authorization for the use of BVO as a food ingredient intended to stabilize flavoring oils in fruit-flavored beverages. There are no authorizations for other uses of BVO in foo...

The Farm Service Agency (FSA) is announcing the availability of $19 million through the new Food Safety Certification for Specialty Crops Program (FSCSC) for specialty crop operations that incur eligible on-farm food safety program expenses to obtain or renew a food safety certification in calendar years 2024 and 2025. To be eligible for assistance with expenses related to a 2024 food safety certification, the certification must have been issued on or after June 26, 2024. Specialty crop operatio...

The U.S. Codex Office is sponsoring a public meeting on September 3, 2024. The objective of the public meeting is to provide information and receive public comments on agenda items and draft U.S. positions to be discussed at the 44th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU44) of the Codex Alimentarius Commission (CAC), which will convene in Dresden, Germany, from October 2-6, 2024. The U.S. Manager for Codex Alimentarius and the Under Secretary for...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Laboratory Developed Tests: Small Entity Compliance Guide." The laboratory developed tests (LDT) final rule amended FDA's regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. This small entity compliance guide (SECG) is intended to help small ...

The Food and Drug Administration (FDA, Agency, or we) has determined that INVEGA (paliperidone) extended-release tablet, 1.5 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory req...

The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled "Modifications to the List of Recognized Standards, Recognition List Number: 062" (Recognition List Number: 062), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devic...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #278 entitled "Human User Safety in New and Abbreviated New Animal Drug Applications." This guidance is intended for sponsors interested in pursuing the approval, or conditional approval, of new animal drugs (including new generic animal drugs). This guidance addresses general principles of human user safety (HUS) assessment for new animal drugs, sources of data, mitigation stra...

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule revising the requirements concerning current good manufacturing practice (CGMP), postmarketing safety reporting, and labeling that apply to certain medical gases. This final rule also establishes regulations regarding certification of designated medical gases. This final rule satisfies the medical gas rulemaking requirements of the Consolidated Appropriations Act, 2017....

FMCSA announces its decision to provisionally renew an exemption requested by the Agricultural and Food Transporters Conference (AFTC) of American Trucking Associations (ATA), which will allow certain alternative methods for the securement of agricultural commodities transported in wood and plastic boxes and bins and large fiberglass tubs, as well as hay, straw, and cotton bales that are grouped together into large singular units. The exemption is renewed for 6 months, unless revoked earlier....

The Food and Drug Administration (FDA or Agency) is correcting a notice that appeared in the Federal Register on May 23, 2024. The document announced the availability of a draft revised guidance for industry (GFI) #115 (VICH GL22) entitled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1)." The document erroneously included incorrect contact information. This document corrects that error....

The Food and Drug Administration (FDA, the Agency, or we) is proposing to grant an exemption for certain cottage cheese products from the requirements of the Requirements for Additional Traceability Records for Certain Foods rule (the Food Traceability Rule). The Agency is taking this action in accordance with the FDA Food Safety Modernization Act and FDA's implementing regulations....

The Center for Drug Evaluation and Research (CDER) within the Food and Drug Administration (FDA or we) is announcing a meeting program, the Emerging Drug Safety Technology Meeting (EDSTM) program. These meetings will be administered by staff in the newly established CDER Emerging Drug Safety Technology Program (EDSTP). EDSTMs provide applicants with an approved application and/or other relevant parties supporting industry's pharmacovigilance (PV) activities (e.g., academia, contract research org...

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 ethyl cellulose as a matrix scaffolding for tracers, and the ethyl cellulose shall not exceed 80 percent of the tracer. This action is in response to a food additive petition filed by Micro-Tracers, Inc....

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.

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 c...

The Food and Drug Administration (FDA or we) has determined that there is sufficient laboratory capacity in the Laboratory Accreditation for Analyses of Foods (LAAF) program for the import- related food testing covered by the LAAF regulation for mycotoxins. As sufficient capacity is reached for additional analytes covered under the import-related food testing provisions of the LAAF regulation, those specific analytes and compliance dates will be posted on the LAAF Dashboard. Owners and consignee...

The Food and Drug Administration (FDA, we, or the Agency) is extending the comment period for a revised draft Introduction, and a revised draft Appendix 1, within a multichapter guidance for industry entitled "Hazard Analysis and Risk-Based Preventive Controls for Human Food" which were announced in the Federal Register of February 2, 2024. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments before FDA begins work on ...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft revised guidance for industry (GFI) #115 (VICH GL22) entitled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1)." This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). In order to establish the safety of vete...

In accordance with the Federal Advisory Committee Act, FSIS is announcing that the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) will hold a virtual public meeting on June 24, 2024. The Committee will provide updates on FSIS' Genomics charge and the U.S. Food and Drug Administration's (FDA's) Cronobacter spp. in Powdered Infant Formula charge....

The Food and Drug Administration (FDA, Agency, or we) is announcing the withdrawal of the Center for Veterinary Medicine's (CVM's) Program Policy and Procedures Manual Guide (PPM) 1240.3605 Regulating Animal Foods with Drug Claims. This 1998 document presented guidance to CVM staff for the regulation of animal food that may have intended uses that result in the products also being drugs. FDA is withdrawing PPM 1240.3605 after determining that it no longer reflects Agency current thinking....

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Remanufacturing of Medical Devices." This final guidance is intended to help clarify whether activities performed on devices are likely "remanufacturing." This final guidance also clarifies existing regulatory requirements for remanufacturers and includes recommendations for information that should be included in labeling to help assure the continued quality, safety, and effectiveness of...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products; Draft Guidance for Industry." Allogeneic cells of human origin may be expanded in culture to manufacture medical products consisting of live cells, inactivated cells, cell lysates, or other cell-based materials such as cell-derived particles. The draft guidance document provides sponsors of allogene...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #287 entitled "Raw Data for Safety and Effectiveness Studies." This guidance provides information to animal drug sponsors (sponsors) on the use of raw data in the Center for Veterinary Medicine's (CVM's) review of safety and effectiveness studies submitted in support of new animal drug applications. This guidance also describes our recommendations for submitting raw data....

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled "Revocation of Uses of Partially Hydrogenated Oils in Foods: Guidance for Industry; Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entities comply with our regulations after we revoked specific requirements pertaining to the use of partially hydrogenated oils in certain foods or as a direct or indirect food substance....

The Food and Drug Administration (FDA, Agency, or we) has determined that FLUDARABINE PHOSPHATE Injection, 50 milligrams (mg)/2 milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory ...

The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Environmental Defense Fund, et al., proposing that the food additive regulations be amended to remove fluorinated polyethylene.

The Food and Drug Administration (FDA or Agency) is establishing a public docket entitled "Promoting Effective Drug Development: Identifying Opportunities and Priorities for the Food and Drug Administration's Office of Clinical Pharmacology." The purpose of this docket is to solicit input from interested parties on specific and actionable policy topics that could be prioritized, developed, and implemented by the staff of the Center for Drug Evaluation and Research's (CDER's) Office of Clinical P...

This final rule considers public comments submitted in response to the proposed rule revising the WIC food packages published on November 21, 2022. It revises regulations to align the WIC food packages with the current Dietary Guidelines for Americans and to reflect recommendations from the National Academies of Science, Engineering, and Medicine while promoting nutrition security and equity and considering program administration. The changes are intended to provide WIC participants with a wider...

The Food and Drug Administration (FDA, Agency, or we) 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.

The Food and Drug Administration (FDA, Agency, or we) has determined that VISTARIL (hydroxyzine pamoate) Oral Suspension, 25 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for VISTARIL (hydroxyzine pamoate) Oral Suspension, 25 mg/5 mL, if all other legal and regulatory requirements are met....

The Food and Drug Administration (FDA, Agency, or we) has determined that KEMSTRO (baclofen) orally disintegrating tablets, 10 milligrams (mg) and 20 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for baclofen orally disintegrating tablets, 10 mg and 20 mg, if all other legal and regulatory requirements are met....

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.

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements....

The Food and Drug Administration (FDA or Agency) has determined that GLUCOTROL (glipizide) tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requiremen...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies." This guidance provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies to the FDA Adverse Event Reporting System (FAERS). This guidance finalizes the draft ...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Providing Regulatory Submissions in Electronic Format: IND Safety Reports." This guidance finalizes the draft guidance of the same name published on October 30, 2019, and describes the electronic format sponsors will be required to use when they electronically submit investigational new drug application (IND) safety reports to the Center for Drug Evaluation and Research (CDE...

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 c...

The Food and Drug Administration (FDA, Agency, or we) has determined that ISUPREL (isoproterenol hydrochloride) injection, 0.2 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ISUPREL (isoproterenol hydrochloride) injection, 0.2 mg/mL, if all other legal and regulatory requirements are met....

The Food and Drug Administration (FDA or we) is amending its regulations relating to the procedures for determining that a premarket notification for a food contact substance (FCN) is no longer effective. The final rule provides additional reasons that could form the basis for FDA to determine that an FCN is no longer effective. The final rule also ensures that manufacturers or suppliers have the opportunity to provide input before we determine that an FCN is no longer effective. We are making t...

The Food and Drug Administration (FDA, we, or the Agency) is extending the comment period for two chapters of a multichapter draft guidance entitled "Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry," which were announced in the Federal Register of September 27, 2023. The relevant draft chapters are entitled "Chapter 11-- Food Allergen Program" and "Chapter 16--Acidified Foods." We are taking this action in response to a request for an extension to a...

The Food and Drug Administration (FDA or Agency) has determined that DUEXIS (ibuprofen and famotidine) tablet, 800 milligrams (mg) ibuprofen and 26.6 mg famotidine, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant l...

The Food and Drug Administration (FDA or Agency) has determined that NUCYNTA (tapentadol hydrochloride) solution, equivalent (eq) 20 milligrams (mg) base/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for tapentadol hydrochloride solution, eq 20 mg base/mL, if all other legal and regulatory requirements are met....

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance updates the existing E2D guidance entitled "E2D Post-Approval Safet...

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solic...

The United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) proposes to amend the USDA organic regulations to clarify standards for organic mushrooms and organic pet food. Specific standards for these products do not currently exist. Instead, these products have been certified organic using the general organic standards for crops, livestock, and handling. However, this approach is not ideal as the current regulations do not address unique aspects of either product. AM...

This rulemaking proposes important modifications to make the application of serious deficiency procedures in the Child and Adult Care Food Program and Summer Food Service Program consistent, effective, and in line with current requirements under the Richard B. Russell National School Lunch Act. The serious deficiency process provides a systematic way for State agencies and sponsoring organizations to correct serious management problems, and when that effort fails, protect Child Nutrition Program...

In accordance with the Federal Advisory Committee Act, this notice is announcing the intention of the USDA to renew the committee for the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) and its charter.

The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a revised draft Introduction, and a revised draft Appendix 1, within a multichapter guidance for industry entitled "Hazard Analysis and Risk-Based Preventive Controls for Human Food." This multichapter draft guidance, when finalized, will explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled "Current Good Manufact...

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 propionate as a source of chromium in turkey feed. This action is in response to a food additive petition filed by Kemin Industries, Inc....

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final document entitled "Best Practices for FDA Staff in the Postmarketing Safety Surveillance of Human Drug and Biological Products." The 21st Century Cures Act (Cures Act), enacted on December 13, 2016, requires that FDA make publicly available on its internet website best practices for certain postmarketing drug safety surveillance activities. This final document sets forth risk-based principles for FDA's con...

The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Environmental Defense Fund, et al., proposing that the food additive regulations be amended to remove four specified solvents.

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 calcium formate as a feed acidifying agent, to lower the pH, in complete swine and poultry feeds at levels not to exceed 1.2 percent of the complete feed. This action is in response to a food additive petition filed by LANXESS Corp....

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....

The Food and Drug Administration (FDA or we) is proposing to amend our regulations to revoke the authorization for the use of brominated vegetable oil (BVO) in food. This action is being taken because there is no longer a reasonable certainty of no harm from the continued use of BVO in food. Specifically, the proposed rule would revoke the authorization for the use of BVO as a food ingredient intended to stabilize flavoring oils in fruit-flavored beverages. There are no authorizations for other ...

The Food and Drug Administration (FDA or Agency) is announcing the fiscal year (FY) 2024 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA)....

The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2024 annual fee rate for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) that is authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). This fee is effective on August 1, 2023 and will remain in effect through September 30, 2024....

The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2024 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program that is authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). We are also announcing the fee rate for certification bodies t...

In accordance with the Paperwork Reduction Act of 1995 and the Office of Management and Budget (OMB) regulations, FSIS is announcing its intention to collect information from interviews on consumer food safety knowledge, attitudes, and behaviors. FSIS will also collect consumer responses to food safety messages related to home cooking to gather feedback on message content and format. This is a new information collection with 547 hours....