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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements  Office of Inspector General (OIG) 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 Monetary Penalties and Intermediate Sanctions for Certain Violations by Health Maintenance Organizations and Competitive Medical Plans  Office of Inspector General (OIG) Proposed
Guidance for Importation of Human Remains into the United States for Interment or Subsequent Cremation  Centers for Disease Control and Prevention (CDC) Proposed
Office Based Opioid Use Disorder Treatment Billing  Centers for Medicare & Medicaid Services (CMS) Proposed
Draft Guidance for Industry: Regulatory Submissions to OFAS, Part X Appendices  Food and Drug Administration (FDA) Proposed
EDPPPS Proposed Edits Tool V1 - December 2011  Centers for Medicare & Medicaid Services (CMS) Proposed
ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry  Food and Drug Administration (FDA) Proposed
Bioavailability Studies Submitted in NDAs or INDs – General Considerations  Food and Drug Administration (FDA) Proposed
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