Search

National Institute of Dental and Craniofacial Research Notice of Closed Meeting

The National Institute of Dental and Craniofacial Research (NIDCR) has issued a notice announcing a closed advisory council meeting scheduled for May 27-28, 2026. The meeting is closed to the public as it will involve discussion of grant applications and other privileged or predecisional matters. This is a routine administrative announcement.

CDC Agency Forms Undergoing Paperwork Reduction Act Review

CDC has submitted the information collection request "Poison Center Collaborations for Public Health Emergencies (PCCPHE)" to OMB for review under the Paperwork Reduction Act. The notice allows an additional 30 days for public comments following three comments received from the prior January 2026 notice. America's Poison Centers, a national network of 53 poison centers, serves as CDC's key partner for this surveillance initiative.

Center for Tobacco Products Complaint, Apr 13, 2026

FDA Center for Tobacco Products (CTP) filed a complaint on April 13, 2026. The document is classified as closed in the Regulations.gov system (Docket FDA-2026-H-3804). The full complaint text is not available for public viewing on the regulatory portal. This appears to be a formal complaint related to tobacco product regulation.

BILTRICIDE Not Withdrawn for Safety or Effectiveness

FDA has determined under 21 CFR 314.161 that BILTRICIDE (praziquantel) oral tablet, 600 mg, was not withdrawn from sale for reasons of safety or effectiveness. The drug product, which was discontinued by Bayer Healthcare Pharmaceuticals in February 2024 and moved to the Orange Book's Discontinued Drug Product List, retains its eligibility for ANDA approvals. Novitium Pharma LLC submitted a citizen petition requesting this determination, which FDA granted based on review of Agency records.

FDA DMB Acknowledgment Letter to Hyman Phelps McNamara

FDA Division of Manufacturing and Quality (DMB) within CDER sent an acknowledgment letter to Hyman, Phelps & McNamara, P.C. in response to submission FDA-2026-P-4018. The acknowledgment indicates receipt of the submission without substantive review or determination at this stage. No regulatory obligations, compliance deadlines, or enforcement actions are imposed by this document.

Suitability Petition to FDA

Hyman, Phelps & McNamara, P.C. filed a Suitability Petition with the FDA under docket FDA-2026-P-4020-0001. The petition appears to request FDA approval for a drug product change under applicable administrative procedures. The filing was submitted to CDER for review.

FDA Suitability Petition, Comment Period Open

FDA Suitability Petition, Comment Period Open

SAMHSA Information Collection OMB Review Request

SAMHSA, a division of HHS, has submitted an information collection request to OMB for review under the Paperwork Reduction Act. The notice announces a 30-day public comment period on proposed data collection activities related to substance abuse and mental health services programs. This is a standard administrative action to gather feedback on existing or modified information collection requirements.

HRSA AIDS Drug Assistance Program Data Report Extension Request

The Health Resources and Services Administration (HRSA) is seeking public comment on extending OMB Control No. 0915-0345 for the AIDS Drug Assistance Program (ADAP) Data Report. The comment period closes on May 13, 2026. This is an administrative information collection extension request for an existing data reporting mechanism used to monitor ADAP program activities.

Determination That BILTRICIDE (Praziquantel) 600mg Tablet Was Not Withdrawn From Sale

The FDA has issued a determination that BILTRICIDE (Praziquantel) oral tablet, 600 milligrams, was not withdrawn from sale for reasons of safety or effectiveness. This determination affects pharmaceutical manufacturers, healthcare providers, and patients who rely on this anti-parasitic medication. The notice confirms the drug remains available on the market and was not subject to removal due to regulatory safety concerns.