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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Surgical Staplers and Staples for Internal Use - Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications: Draft Guidance for Industry and Review Staff  Food and Drug Administration (FDA) Proposed
Solicitation of Comments on the OIG/HCFA Special Advisory Bulletin on the Patient Anti-Dumping Statute  Office of Inspector General (OIG) Proposed
Solicitation of Information and Recommendations for Developing Compliance Program Guidance for Recipients of NIH Research Grants  Office of Inspector General (OIG) Proposed
Solicitation of New Safe Harbors and Special Fraud Alerts  Office of Inspector General (OIG) Proposed
Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti- Kickback Statute and Beneficiary Inducements CMP  Office of Inspector General (OIG) Proposed
Risk Corridors MLR Guidance   Centers for Medicare & Medicaid Services (CMS) Proposed
Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry Edition 2 (French Translation)  Food and Drug Administration (FDA) Proposed
Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry  Food and Drug Administration (FDA) Proposed
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