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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Alcoholism: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry  Food and Drug Administration (FDA) Proposed
ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs  Food and Drug Administration (FDA) Proposed
Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for Industry  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Regulatory Submissions to OFAS, Part VIII New Protein Consultations  Food and Drug Administration (FDA) Proposed
CPG Sec 555.320 Listeria monocytogenes  Food and Drug Administration (FDA) Proposed
Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry  Food and Drug Administration (FDA) Proposed
1993 Draft Redbook II  Food and Drug Administration (FDA) Proposed
Notice of Proposed Rulemaking (NPRM) on Designation Renewal System Changes  Administration for Children and Families (ACF) Proposed
2020 Secretarial Determination to Lower Head Start Center-based Service Duration Requirement  Administration for Children and Families (ACF) Proposed
This Guidance Portal contains 50210 documents.

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