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83C - Executive Order 14168 Compliance

ICR 202609-0910-004 · OMB 0910-0167 · Object 173079700.

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83C - Executive Order 14168 Compliance
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2025-04-15
2026-09-22
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FOOD AND DRUG ADMINISTRATION
Non-substantive Change Request
OMB Control Nos. 0910-0167
Orphan Drugs

Date Submitted: April 15, 2025


Summary of request: The Food and Drug Administration is requesting a change request to revise questions to align with Executive Order (EO) 14168 Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.

Description of Changes Requested: Remove the prefix “Mx.” from the fields “Primary Contact Prefix” and “Sponsor U.S. Resident Agent Prefix” to be in accordance with EO 14168. 

x Revision of an existing question(s)
 Deletion of an existing question(s)
Description of Changes to Burden (if applicable):

N/A: No change in burden

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Document
Tracked Changes Version
Clean Version
Form FDA 4035