14 new federal notices

New in the Federal Register

Rules, proposed rules, and notices from the FDA and USDA that touch food, labels, and organic.

• Rule · Health and Human Services Department Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use

  The Food and Drug Administration (FDA) is classifying the infant pulse rate and oxygen saturation monitor for over-the-counter use 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 infant pulse rate and oxygen saturation monitor for over-the-counter use. We are taking this action...

• Rule · Health and Human Services Department Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit

  The Food and Drug Administration (FDA) is classifying the hematopoietic cell enrichment kit 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 hematopoietic cell enrichment kit. We are taking this action because we have determined that classifying the device into class II will provide a...

• Rule · Health and Human Services Department Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens

  The Food and Drug Administration (FDA) is classifying the system for detection of nucleic acid from non-viral microorganism(s) causing sexually transmitted infections using home-collected 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 system for detection of nucleic acid...

• Rule · Agriculture Department Raisins Produced From Grapes Grown in California; Order Amending Marketing Order No. 989

  This final rule amends Marketing Order No. 989, which regulates the handling of raisins produced from grapes grown in California. The Department of Agriculture approves and adopts amendments proposed by the Raisin Administrative Committee (Committee) after due consideration of a public hearing record, and after California raisin producers voted in favor of such amendments in a referendum. This rule reduces the...

• Proposed Rule · Health and Human Services Department Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Draft Guidance for Industry; Availability

  The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry titled "Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants." The draft guidance states that, at this time and based on our current understanding of the risks, FDA does not intend to enforce certain...

• Notice · Health and Human Services Department Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biologics License Applications, Procedures and Requirements

  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.

• Notice · Health and Human Services Department Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investigational Drugs for Treatment Use

  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.

• Notice · Health and Human Services Department Amneal Pharmaceuticals of New York, LLC; Withdrawal of Approval of Abbreviated New Drug Application for Celecoxib Capsules, 50 Milligrams, 100 Milligrams, 200 Milligrams, and 400 Milligrams

  The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 208833 for Celecoxib capsules, 50 milligrams (mg), 100 mg, 200 mg, and 400 mg, held by Amneal Pharmaceuticals of New York, LLC, 50 Horseblock Rd., Brookhaven, NY 11719 (Amneal). Amneal requested withdrawal of approval of this application and has waived its opportunity for a hearing.

• Notice · Health and Human Services Department Challenges and Solutions in Lot-Level Food Traceability; Public Meeting

  The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting titled "Challenges and Solutions in Lot- Level Food Traceability." The purpose of the meeting is to provide a forum for the public to share information on continued implementation of the "Requirements for Additional Traceability Records for Certain Foods" final rule and areas of concern, especially as they relate to lot-level...

• Notice · Health and Human Services Department Determination of Regulatory Review Period for Purposes of Patent Extension; MONOFERRIC

  The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MONOFERRIC and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

• Notice · Health and Human Services Department Determination That LASIX (Furosemide) Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

  The Food and Drug Administration (FDA, Agency, or we) has determined that LASIX (furosemide) oral solution, 10 milligrams (mg)/ 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...

• Notice · Health and Human Services Department Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction

  The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on June 3, 2026. The document announced the withdrawal of approval of 16 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of July 6, 2026. The document indicated that FDA was withdrawing approval of ANDA 207366 for ribavirin solution, 6 grams/vial, held by Navinta LLC, 1499 Lower Ferry...

• Notice · Health and Human Services Department Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZANVASTRO (Zilganersen)

  The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority...

• Notice · Health and Human Services Department Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications

  The Food and Drug Administration (FDA or Agency) is withdrawing approval of 37 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Summaries are the agencies' own words. Read the full document before you act on it.