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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Issue Date
Overview of the Administrative Offset Program  Administration for Children and Families (ACF) Final
HIPAA Enforcement Rule  Office for Civil Rights (OCR) Final
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers : Guidance for Industry  Food and Drug Administration (FDA) Final
Format for Traditional and Abbreviated 510(k)s: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
FPLS Security Awareness Training  Administration for Children and Families (ACF) Final
Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics : Guidance for Stakeholders and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Unique Device Identifier System: Frequently Asked Questions, Vol. 1 : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
March 2020 Child Support Report  Administration for Children and Families (ACF) Final
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