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Agency Information Collection Activities: Proposed Collection; Comment Request

CMS published a Federal Register notice on April 10, 2026, requesting public comments on a proposed information collection activity under the Paperwork Reduction Act. The notice opens a 60-day comment period closing June 9, 2026. Healthcare providers and organizations that submit information to CMS may be indirectly affected by any new or modified reporting requirements that result from this collection activity.

Center for Scientific Review Notice of Closed Meetings

The NIH Center for Scientific Review published a notice announcing five closed meetings scheduled for May 5-7, 2026, to review and evaluate grant applications for mentored training, cancer research, infertility technologies, and research excellence awards. The meetings will be held virtually and closed to the public under Federal Advisory Committee Act exemptions to protect confidential trade secrets, commercial property, and personal information associated with grant applications.

Center for Scientific Review Notice of Closed Meetings

NIH Center for Scientific Review announces five closed meetings scheduled for May 7, 2026 to review grant applications. Meetings are closed under Federal Advisory Committee Act provisions because discussions could disclose confidential trade secrets, patentable material, and personal information of applicants.

Council of Councils Meeting Notice, May 14-15, 2026

NIH announces a two-day Council of Councils meeting on May 14-15, 2026, in Bethesda, MD. The meeting includes open sessions covering welcome remarks, DPCPSI reports, and NIH program updates, as well as a closed session for grant application review. The closed portions will address confidential trade secrets, patentable material, and personal information related to grant applications. The public may attend open sessions via videocast or in person, and written comments may be submitted to the Contact Person.

Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices

The FDA published a notice in the Federal Register seeking public comment on a proposed information collection related to premarket approval of medical devices. The collection pertains to burden hour estimates for required submissions under the Paperwork Reduction Act. Comments are due within 60 days of the April 10, 2026 publication date.

GSK Withdraws Wellcovorin NDA - Leucovorin Calcium Tablets Discontinued

FDA withdrew approval of NDA 018342 for Wellcovorin (leucovorin calcium) tablets at GSK's written request after the company notified the Agency the drug products were no longer marketed. GSK waived its opportunity for a hearing and requested withdrawal under 21 CFR 314.150(c). Existing inventory may be dispensed until depleted or until expiration dates.

Petition Submission Information Collection: Food Additive, Color Additive, Master File, Form 3503

The FDA published a notice announcing a 60-day public comment period on proposed information collection requirements for petition submissions under the Paperwork Reduction Act. The collection covers food additive petitions, color additive petitions including labeling, master file information submissions, and electronic submissions using FDA Form 3503. Comments must be submitted by June 9, 2026.

Color Additive Certification Information Collection Comment Request

The FDA published a notice in the Federal Register announcing an opportunity for public comment on a proposed information collection related to color additive certification under the Paperwork Reduction Act. The notice solicits comments on the burden associated with color additive certification requirements. Comments must be submitted by June 9, 2026.

FDA Requirement for Patent Information to Clark & Elbing

FDA Requirement for Patent Information to Clark & Elbing

USPTO Letter to FDA CDER on Patent Matters, Apr 8

USPTO sent an inter-agency letter to FDA CDER regarding patent-related matters. The communication appears in a FDA regulatory docket and addresses coordination between the two agencies on intellectual property issues. No specific regulatory requirements or compliance obligations are detailed in the available documentation.