The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled "AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information" that appeared in the Federal Register of April 29, 2026. In the notice, FDA requested comments to solicit input on a proposed pilot program to assess how artificial intelligence (AI)-enabled technologies can improve efficiency, speed, and quality of decision- making in early phase clinical tria

Original title: “AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information; Extension of Comment Period”

The Food and Drug Administration (FDA or we) is reopening the comment period for the notification of petition, published in the Federal Register of January 11, 2024, announcing that we filed a color additive petition proposing that the color additive regulations be amended to remove three specified solvents. FDA is reopening the comment period to allow for the submission of any updated data and other information over the last two years.

Original title: “Color Additive Petition from Environmental Defense Fund, et al.; Request To Amend the Color Additive Regulations To Remove the Solvents Ethylene Dichloride, Methylene Chloride, and Trichloroethylene; Reopening of the Comment Period”

The Food and Drug Administration (FDA) is classifying the endoscopic suturing device for altering gastric anatomy for weight loss 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 endoscopic suturing device for altering gastric anatomy for weight loss. We are taking this action because we have determined that classifying the device into class II will provide a reaso

Original title: “Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Suturing Device for Altering Gastric Anatomy for Weight Loss”

The Food and Drug Administration (FDA or we) is reopening the comment period for the notification of petition, published in the Federal Register of January 11, 2024, announcing that we filed a food additive petition proposing that the food additive regulations be amended to remove four specified solvents. FDA is reopening the comment period to allow for the submission of any updated data and other information over the last two years.

Original title: “Food Additive Petition From Environmental Defense Fund, et al.; Request To Amend the Food Additive Regulations To Remove the Solvents Benzene, Ethylene Dichloride, Methylene Chloride, and Trichloroethylene; Reopening of the Comment Period”

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 Food Traceability Rule and areas of concern, especially as they relate to lot-level tracking, and identify potential flexibilities to support compliance. In addition, FDA has developed a discussion paper titled "Identifying

Original title: “Challenges and Solutions in Lot-Level Food Traceability; Public Meeting and Request for Comments”

The FDA will convene its vaccines advisory panel to discuss seasonal COVID-19 vaccines—a surprise move after Health Secretary and vaccine skeptic Robert F. Kennedy, Jr. overhauled a separate vaccine committee.

Original title: “FDA assembles vaccine experts to update COVID-19 formulation”

Committee on Banking, Housing, and Urban Affairs. Hearings held. Hearings printed: S.Hrg. 118-655.

Original title: “S 3311: American Made Pharmaceuticals Act of 2023”

The Secretary is issuing a Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide liability protection for activities related to medical countermeasures against Andes virus consistent with the terms of the Declaration.

Original title: “Notice of Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against Andes Virus”

The Food and Drug Administration (FDA or Agency) is announcing that all outstanding hearing requests for estrogen-androgen fixed- combination drug products under Docket FDA-1998-P-0083 (formerly 76N- 0377) (DESI 7661) have been withdrawn. Therefore, as proposed in the April 14, 2003, notice of opportunity for hearing (NOOH), FDA finds that the products subject to this proceeding have not been shown to be effective for use under the conditions of use prescribed, recommended, or suggested in the l

Original title: “Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. Tablets; Withdrawal of Hearing Requests; Final Resolution of Drug Efficacy Study Implementation 7661”

The Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services (HHS) issues this interim final rule with request for comments to amend its Foreign Quarantine Regulations. This interim final rule provides a procedure for the Secretary acting through the CDC Director or other delegate to suspend the introduction of persons from designated countries or places, if required, in the interest of public health.

Original title: “Control of Communicable Diseases; Foreign Quarantine”

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institutes of Health will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Original title: “Proposed Collection; 60-Day Comment Request; Data and Specimen Hub (DASH) (Eunice Kennedy Shriver National Institute of Child Health and Human Development)”

Original title: “Agency Forms Undergoing Paperwork Reduction Act Review”

Original title: “Agency Forms Undergoing Paperwork Reduction Act Review”

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 Rape Prevention and Education (RPE) Program. This program is designed to collect dat

Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”

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 Advancing Violence Epidemiology in Real-Time (AVERT). The AVERT program provides fun

Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”

Original title: “Agency Forms Undergoing Paperwork Reduction Act Review”

Draft guidance outlines a “plausible mechanism” pathway to support approval of highly targeted therapies when traditional trials are not feasible. It is designed to help sponsors generate substantial evidence of effectiveness and safety using a combination of clinical, nonclinical, and manufacturing data tailored to highly specific therapies.2 · “President Trump promised to accelerate cures for American families—and we are delivering, especially for children with ultra-rare diseases who cannot afford to wait,” said Health and Human Services Secretary Robert F. At its core, the approach emphasizes several foundational elements: identifying the disease-causing mechanism, demonstrating that the therapy directly targets that mechanism, and confirming successful biological engagement. Sponsors are also expected to rely on well-characterized natural history data and show improvements in clinical outcomes or validated biomarkers. “This guidance is a critical step the FDA is taking to tailor our regulatory approach to patients with ultra-rare conditions,” said FDA Commissioner Marty Makary, MD, MPH. https://www.fda.gov/news-events/press-announcements/fda-launches-framework-accelerating-development-individualized-therapies-ultra-rare-diseases · 2. Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause: Draft Guidance for Industry. FDA. Accessed March 2, 2026. ... 3. FDA Removes Two Study Requirement for New Drug Approval Process. Applied Clinical Trials. Makary and Prasad argued that advances in biology and trial design justify the change, writing, “In this setting, over-reliance on two trials no longer makes sense.” · The policy is expected to streamline development while placing greater emphasis on study quality, biological plausibility, and overall strength of evidence. 1. FDA Launches Framework for Accelerating Development of Individualized Therapies for Ultra-Rare Diseases.

Original title: “FDA Introduces New Framework to Advance Individualized Therapies for Ultra-Rare Diseases | Applied Clinical Trials Online”

Original title: “Publications and Information Products from the National Center for Health Statistics”

The Administration for Children and Families proposes to amend the Grants to States for Public Assistance Programs regulations, the General Administration--State Plans and Grant Appeals regulations, the General Administration--Public Assistance Programs regulations, the Training and Use of Subprofessionals and Volunteers regulations, the Coverage and Conditions of Eligibility in Financial Assistance Programs regulations, the Financial Assistance to Individuals regulations, the Administration of

Original title: “Reducing Bureaucracy and Burden for Family Assistance Programs”

The Food and Drug Administration (FDA) is announcing the renewal of the Pulmonary-Allergy Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Pulmonary- Allergy Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the May 30, 2028, expiration date.

Original title: “Advisory Committee; Pulmonary-Allergy Drugs Advisory Committee; Renewal”