Title 21

PART 112 SUBPART R

Subpart R - Withdrawal of Qualified Exemption

• 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 264, 271.
• 80 FR 74547, Nov. 27, 2015, unless otherwise noted.

21:2.0.1.1.12.17.1.1	SECTION 112.201	112.201 Under what circumstances can FDA withdraw a qualified exemption in accordance with the requirements of § 112.5
21:2.0.1.1.12.17.1.2	SECTION 112.202	112.202 What procedure will FDA use to withdraw an exemption
21:2.0.1.1.12.17.1.3	SECTION 112.203	112.203 What information must FDA include in an order to withdraw a qualified exemption
21:2.0.1.1.12.17.1.4	SECTION 112.204	112.204 What must I do if I receive an order to withdraw a qualified exemption applicable to my farm
21:2.0.1.1.12.17.1.5	SECTION 112.205	112.205 Can I appeal or request a hearing on an order to withdraw a qualified exemption applicable to my farm
21:2.0.1.1.12.17.1.6	SECTION 112.206	112.206 What is the procedure for submitting an appeal
21:2.0.1.1.12.17.1.7	SECTION 112.207	112.207 What is the procedure for requesting an informal hearing
21:2.0.1.1.12.17.1.8	SECTION 112.208	112.208 What requirements are applicable to an informal hearing
21:2.0.1.1.12.17.1.9	SECTION 112.209	112.209 Who is the presiding officer for an appeal and for an informal hearing
21:2.0.1.1.12.17.1.10	SECTION 112.210	112.210 What is the timeframe for issuing a decision on an appeal
21:2.0.1.1.12.17.1.11	SECTION 112.211	112.211 When is an order to withdraw a qualified exemption applicable to a farm revoked
21:2.0.1.1.12.17.1.12	SECTION 112.213	112.213 If my qualified exemption is withdrawn, under what circumstances would FDA reinstate my qualified exemption

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