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U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 28, 2025

All TitlesTitle 21Chapter IPart 99Subpart C - Subpart C—Manufacturer's Submissions, Requests, and Applications
§ 99.201 - Manufacturer's submission to the agency.
§ 99.203 - Request to extend the time for completing planned studies.
§ 99.205 - Application for exemption from the requirement to file a supplemental application.
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