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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment Guidance for Industry: Draft Guidance for Industy  Food and Drug Administration (FDA) Proposed
Informed Consent: Draft Guidance for IRBs, Clinical Investigators, and Sponsors  Food and Drug Administration (FDA) Proposed
2022 Key Dates Table   Centers for Medicare & Medicaid Services (CMS) Proposed
Solicitation of Information and Recommendations for Supplementing the Guidance Provided in the Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs  Office of Inspector General (OIG) Proposed
Solicitation of New Safe Harbors and Special Fraud Alerts  Office of Inspector General (OIG) Proposed
Draft OIG Compliance Program Guidance for Pharmaceutical Manufacturers  Office of Inspector General (OIG) Proposed
Information Blocking; Office of Inspector General’s Civil Money Penalty Rules  Office of Inspector General (OIG) Proposed
Proposed Rule: Safe Harbor Under the Anti-Kickback Statute for the Waiver of Medicare SELECT Beneficiary Coinsurance and Deductible Amounts  Office of Inspector General (OIG) Proposed
1993 Draft Redbook II  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Regulatory Submissions to OFAS, Part VI GRAS Notices  Food and Drug Administration (FDA) Proposed
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