Food and Drug Administration

On May 6, 2024, the Food and Drug Administration (FDA, the Agency, or we) issued a final rule amending the definition of "in vitro diagnostic products" in FDA's regulations. On March 31, 2025, a federal district court vacated that rule. This final rule reverts to the text of the regulation as it existed prior to the effective date of the May 2024 final rule.

The Food and Drug Administration (FDA or we) is correcting a final rule entitled "New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address" that appeared in the Federal Register of August 22, 2025. That final rule updated regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during April, May, and June of 2025. The final rule published with an inadvertent error. This document corrects that error.

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 effectiveness of these device types.

The Food and Drug Administration (FDA) is making technical amendments to its radiological health regulations to correct an error. On January 20, 2023, FDA published a final rule entitled "Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products" that inadvertently deleted certain existing regulatory text from the Code of Federal Regulations. This action corrects the error by restoring the inadvertently deleted regulatory text. This action is editorial in nature and is intended to ensure accuracy and clarity in FDA's regulations by restoring inadvertently deleted regulatory text.

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. (General Mills or petitioner). We are also updating the reference for the vitamin D<INF>3</INF> specifications.

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 or the Agency) is announcing the termination of the Arthritis Advisory Committee (Committee). Due to that termination, this final rule removes the Committee from the Agency's list of standing advisory committees in 21 CFR 14.100.

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April, May, and June 2025. The animal drug regulations are also being amended to improve their accuracy and readability.

The Food and Drug Administration (FDA or we) is confirming the effective date of June 26, 2025, for the final order that appeared in the Federal Register of May 12, 2025. The final order amends the color additive regulations to provide for the safe use of calcium phosphate as a color additive in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies.

The Food and Drug Administration (FDA or we) is confirming the effective date of June 26, 2025, for the final order that appeared in the Federal Register of May 12, 2025. The final order amends the color additive regulations to provide for the safe use of galdieria extract blue as a color additive at levels consistent with good manufacturing practice (GMP) in: non-alcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milk shakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candy, soft candy and chewing gum, flavored frostings, ice cream and frozen dairy desserts, frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, whipped cream, yogurt, frozen or liquid creamers (including non-dairy alternatives), and whipped toppings (including non-dairy alternatives).

The Food and Drug Administration (FDA or we) is confirming the effective date of June 26, 2025, for the final order that appeared in the Federal Register of May 12, 2025. The final order amends the color additive regulations to provide for the expanded safe use of butterfly pea flower extract as a color additive at levels consistent with good manufacturing practice (GMP) in: ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), and plain corn chips, tortilla chips, and multigrain chips.

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 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 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 that classifying the device into class II 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 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 device into class II 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 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 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 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. 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, 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 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 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 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 multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human 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 classification of the multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens. 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 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 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 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 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 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 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 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 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 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 will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

The Food and Drug Administration (FDA or we) is correcting the order entitled "Listing of Color Additives Exempt from Certification; Gardenia (Genipin) Blue". In the order, FDA amended 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). The order inadvertently misstated the methanol specification. This document corrects that error.

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 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, 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 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 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 the device into class II (special 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 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' 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 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 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 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 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 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, we, or the Agency) is publishing an order setting forth the Agency's final determination to exempt certain class II clinical electronic thermometers from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for such class II clinical electronic thermometers. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulations. FDA is amending the classification language within the Code of Federal Regulations for certain class II clinical electronic thermometers to reflect this final determination. FDA is publishing this order in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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) 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 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 device into class II (special 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, Agency, or we) is announcing the withdrawal of the proposed rule entitled "Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products," which published in the Federal Register of December 27, 2024. FDA is taking this action in response to comments received during the comment period for the proposed rule that warrant further consideration and assessment prior to issuing final regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products pursuant to the Modernization of Cosmetics Regulation Act of 2022.

The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Green Innovation GmbH, proposing that we amend our food additive regulations to provide for the safe use of hydrolyzed lignin as a source of neutral detergent soluble fiber in food for broiler chickens, laying hens, turkeys, growing swine, sows, lactating dairy cows, beef cattle, sheep, goats, salmonids, and adult dogs at no more than 1% of the food on a weight basis or 10 kilograms per metric ton of food.

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 reasonable assurance of safety and effectiveness for these devices.

The Food and Drug Administration (FDA or we) is proposing to issue an order that would remove the color additive regulation that allows for the use of Orange B for coloring the casings or surfaces of frankfurters and sausages. Based on certification data, it appears that Orange B is no longer used for coloring the casings or surfaces of frankfurters and sausages and has not been certified for use as a color additive in food marketed in the United States since 1978. Because the authorized use of Orange B appears to have been abandoned, we have tentatively concluded that this color additive regulation is outdated and unnecessary.

The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Biomin GmbH, proposing that we amend our food additive regulations to provide for the safe use of zearalenone hydrolase to degrade zearalenone in swine food at no less than 10 U/kg complete feed (U = the five-fold enzymatic activity that hydrolyzes 1 [micro]mol zearalenone per minute in a solution of 5 mg/L zearalenone).

The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Evonik Corporation, proposing that we amend our food additive regulations to provide for the safe use of Bacillus velezensis as a source of viable microorganism in animal food for all species.

The Food and Drug Administration (FDA or we) is correcting the proposed rule entitled "Food Standards of Identity Modernization; Pasteurized Orange Juice; Proposed Rule" (90 FR 37817, August 6, 2025). In the proposed rule, FDA proposed to amend the standard of identity (SOI) for pasteurized orange juice (POJ) by lowering the minimum orange juice soluble solids content from 10.5[deg] to 10[deg] Brix. The proposed rule inadvertently included an additional summary of benefits table, an additional summary table and an extraneous paragraph and sentence. This document corrects those errors.

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 we) is proposing to amend the standard of identity for pasteurized orange juice (POJ) by lowering the minimum orange juice soluble solids content from 10.5[deg] to 10[deg] Brix. We tentatively conclude that this proposed amendment will promote honesty and fair dealing in the interest of consumers and provide industry greater flexibility in the manufacture of pasteurized orange juice. This action, if finalized, will respond to a citizen petition submitted by the Florida Citrus Processors Association Inc. and Florida Citrus Mutual Inc.

The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by the Spoonbill Foundation, proposing that we amend our food additive regulations to provide for the safe use of 4'-phosphopantetheine (4'-PPT) as a nutrient in medical food.

The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by APIX Biosciences US LLC, proposing that we amend our food additive regulations to provide for the safe use of cholesterol as a source of sterol in food for honeybees at a level between 0.009 and 0.5% by weight of the food.

The Food and Drug Administration (FDA or we) is proposing to revoke 18 standards of identity for dairy products. FDA is taking this action as 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) 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 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) 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 and effectiveness for this device type.

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 or we) is extending the comment period for the proposed rule entitled "Food Labeling: Front- of-Package Nutrition Information" that appeared in the Federal Register of January 16, 2025. We are taking this action in response to requests for an extension to allow interested parties additional time to submit comments.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Impossible Foods, Inc., proposing that the color additive regulations be amended to expand the safe use of soy leghemoglobin as a color additive to include use in plant-based meat, poultry, and fish analogue products (ground and whole cut).

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 foods can be part of a healthy diet. We also propose to amend certain nutrient content claim regulations to align with current nutrition science and avoid within-label inconsistencies.

The Food and Drug Administration (FDA, the Agency, or we) is proposing a tobacco product standard that would regulate nicotine yield by establishing a maximum nicotine level in cigarettes and certain other combusted tobacco products. FDA is proposing this action to reduce the addictiveness of these products, thus giving people who are addicted and wish to quit the ability to do so more easily. The proposed product standard is anticipated to benefit the population as a whole. For example, it would help to prevent people who experiment with cigarettes and cigars from developing addiction and using combusted tobacco products regularly.

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 a food-contact surface with a pathogen and will explain our current thinking for corrective actions, including corrective actions to remediate contamination of food-contact surfaces, if prevention fails.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to require testing of talc-containing cosmetic products using standardized testing methods for detecting and identifying asbestos that may be present as a contaminant in talc. We are also proposing corresponding adulteration provisions. Asbestos is a potential contaminant in talc, which is used in certain cosmetic products, and is a known human carcinogen. This proposed rule, if finalized, will help protect users of talc-containing cosmetic products from harmful exposure to asbestos given the potential for contamination of these products.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Monterey Mushrooms, LLC, proposing that the food additive regulations for vitamin D<INF>2</INF> mushroom powder be amended to provide for an additional method for producing the additive.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Leprino Nutrition, proposing that the food additive regulations be amended to provide for the safe use of ultraviolet light for the reduction of microorganisms in whey products.

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 provide for the food contact use of 28 ortho-phthalates. We are overruling the objections and denying the requests for a public hearing.

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 proposing to reclassify qualitative hepatitis B virus (HBV) antigen assays, qualitative HBV antibody assays and quantitative assays that detect anti-HBs (antibodies to HBV surface antigen (HBsAg)), and quantitative HBV nucleic acid-based assays, all of which are postamendments class III devices, into class II (general controls and special controls), subject to premarket notification. FDA is also proposing three new device classification regulations along with the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness for each device.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by DSM Biomedical, proposing that the color additive regulations be amended to provide for the safe use of phthalocyanine green to color surgical sutures made of ultra- high molecular weight polyethylene (UHMWPE) for use in general surgery, at a concentration of no more than 0.5 percent by weight of the suture.

The Food and Drug Administration (FDA, Agency, or we) is proposing to revoke the regulations entitled "Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community." FDA is proposing this action because the existing regulations have been superseded in part by the "United States-European Union Amended Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs)" that entered into force in 2017 (2017 Amended Pharmaceutical Annex), are outdated, do not reflect current Agency practice, and are unnecessary.

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, 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, 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 AAFCO. The current MOU, which expires in October 2024, will not be renewed.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by GNT USA, LLC, proposing that the color additive regulations be amended to provide for the safe use of spirulina extract in foods generally in amounts consistent with good manufacturing practice.

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 we) is announcing that we have filed a petition, submitted by Phytolon Ltd., proposing that the color additive regulations be amended to provide for the safe use of prickly pear yellow for the coloring of foods generally in amounts consistent with current good manufacturing practice.

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 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 final guidance.

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the reopening notice entitled "Color Additive Certification; Increase in Fees for Certification Services; Reopening of the Comment Period" that appeared in the Federal Register of April 26, 2024. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments.