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Background Material for Docket FDA-2026-P-4022

FDA published background material under docket FDA-2026-P-4022 on April 14. The document contains supporting information related to a regulatory matter before the agency. No specific regulatory requirements, compliance deadlines, or penalties are stated in the available filing.

Routine Notice Pharmaceuticals
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Variance Application, Christ The King Lutheran Church, FDA, North Carolina

Christ The King Lutheran Church in North Carolina submitted a variance application to the FDA Center for Devices and Radiological Health (CDRH) under docket FDA-2026-V-3505. The specific regulatory requirements or medical device standards at issue are not disclosed in the available metadata. No documents are currently available for public review on Regulations.gov.

Routine Notice Medical Devices
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FDA CDRH Approves Variance for Church

FDA CDRH Approves Variance for Church

Routine Notice
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Electronic Prior Authorization Requirements for Medicare Advantage Medicaid CHIP QHP Issuers

CMS published a proposed rule (CMS-0062-P) requiring Medicare Advantage organizations, state Medicaid and CHIP fee-for-service programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan issuers on the Federally-facilitated Exchanges to implement electronic prior authorization for drugs and extend existing interoperability requirements to drugs. The rule would also require impacted payers to report API endpoints to CMS, adopt HL7 FHIR standards as HIPAA transaction standards, and would establish a definition for "failure to report" enabling civil monetary penalties for applicable manufacturers or GPOs that fail to grant CMS timely access for audits. Comments are due June 15, 2026.

Priority review Consultation Healthcare
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Medicare HCPCS Level II Public Meeting

CMS announces the first biannual 2026 HCPCS Level II public meeting to discuss preliminary coding, Medicare benefit category, and payment determinations for new non-drug and non-biological items and services. The primary meeting is scheduled for June 1, 2026 in Baltimore, MD, with an overflow virtual session on June 2, 2026. Speaker registration closes May 18, 2026, and written comments are due June 3, 2026.

Routine Notice Healthcare
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NCHS Data Detectives Camp, Comments Due Jun 14

CDC's National Center for Health Statistics (NCHS) is seeking public comments on the NCHS Data Detectives Camp educational program. The program is designed to educate students about health statistics and data analysis. Comments are due June 14.

Routine Consultation Public Health
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TB Follow-up Worksheet, Newly-Arrived Deadline 14th Jun

CDC has published a TB Follow-up Worksheet for newly-arrived individuals with a compliance deadline of June 14th. The worksheet provides guidance for TB screening follow-up procedures for newly-arrived populations. Healthcare providers and public health authorities conducting TB screening should utilize this document for compliance purposes.

Routine Notice Public Health
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National Heart, Lung, and Blood Institute Notice of Meeting

The National Heart, Lung, and Blood Institute (NHLBI), part of the NIH, published a Federal Register Notice on April 14, 2026 announcing a public meeting scheduled for May 26, 2026. This notice satisfies requirements under the Federal Advisory Committee Act for public disclosure of advisory committee meetings. No regulatory obligations or compliance deadlines are established by this document.

Routine Notice Healthcare
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Federal Register Daily Issue, 14th Apr

The Federal Register published its daily issue on April 14, 2026, containing 112 documents from 38 agencies across 1006 pages. The issue includes 95 Notices, 8 Proposed Rules, and 9 Rules, along with 3 Significant Documents. This table of contents provides access to documents from agencies including the Air Force Department, Centers for Disease Control and Prevention, and Agriculture Department.

Routine Notice Government Contracting
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Prospective Grant of Exclusive Patent License: Catheter-Based Myotomy Devices And Systems

The National Institutes of Health (NIH) has published a notice of prospective grant of exclusive patent license to Septune for catheter-based myotomy devices and systems. The NIH is seeking public comments on this prospective license agreement. The comment period closes on May 14, 2026.

Routine Notice Intellectual Property

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