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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls: Draft Guidance for Industry and FDA Staff   Food and Drug Administration (FDA) Proposed
Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Surveying, Leveling, or Alignment Laser Products: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed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
Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards   Food and Drug Administration (FDA) Proposed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
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