Title 21

PART 99 SUBPART C

Subpart C - Manufacturer's Submissions, Requests, and Applications

• 21 U.S.C. 321, 331, 351, 352, 355, 360, 360c, 360e, 360aa-360aaa-6, 371, and 374; 42 U.S.C. 262.
• 63 FR 64581, Nov. 20, 1998, unless otherwise noted.

21:1.0.1.1.34.3.63.1	SECTION 99.201	99.201 Manufacturer's submission to the agency.
21:1.0.1.1.34.3.63.2	SECTION 99.203	99.203 Request to extend the time for completing planned studies.
21:1.0.1.1.34.3.63.3	SECTION 99.205	99.205 Application for exemption from the requirement to file a supplemental application.

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