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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Biomarker Qualification: Evidentiary Framework: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Conventional Foley Catheters - Performance Criteria for Safety and Performance Based Pathway: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Use of Investigational Tobacco Products: Draft Guidance for Industry and Investigators  Food and Drug Administration (FDA) Proposed
Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs): Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories  Food and Drug Administration (FDA) Proposed
2022 Key Dates Table   Centers for Medicare & Medicaid Services (CMS) Proposed
Solicitation of New Safe Harbors and Special Fraud Alerts  Office of Inspector General (OIG) Proposed
Solicitation of New Safe Harbors and Special Fraud Alerts  Office of Inspector General (OIG) Proposed
Civil Money Penalties for Prohibited Referrals to Entities Providing Clinical Laboratory Services and for Prohibited Arrangements and Schemes   Office of Inspector General (OIG) Proposed
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