Request that the FDA adopt a policy of enforcement discretion or develop a reduced fee structure under the OTC Monograph Drug User Fee Program (OMUFA) for micro-manufacturers | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-3367

Request that the FDA adopt a policy of enforcement discretion or develop a reduced fee structure under the OTC Monograph Drug User Fee Program (OMUFA) for micro-manufacturers

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensAug 27, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Final Response	Feb 20, 2026	--

Keywords

CDER

Citizen Petition

Mohnark Pharmaceuticals, Inc

adopt a policy of enforcement

discretion or develop a reduced fee

structure under the OTC Monograph

Drug User Fee Program (OMUFA)

for micro-manufacturers

Data from Regulations.gov