Title 21

PART 112 SUBPART P

Subpart P - Variances

• 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.

21:2.0.1.1.12.15.1.1	SECTION 112.171	112.171 Who may request a variance from the requirements of this part
21:2.0.1.1.12.15.1.2	SECTION 112.172	112.172 How may a State, tribe, or foreign country request a variance from one or more requirements of this part
21:2.0.1.1.12.15.1.3	SECTION 112.173	112.173 What must be included in the Statement of Grounds in a petition requesting a variance
21:2.0.1.1.12.15.1.4	SECTION 112.174	112.174 What information submitted in a petition requesting a variance or submitted in comments on such a petition are publicly available
21:2.0.1.1.12.15.1.5	SECTION 112.175	112.175 Who responds to a petition requesting a variance
21:2.0.1.1.12.15.1.6	SECTION 112.176	112.176 What process applies to a petition requesting a variance
21:2.0.1.1.12.15.1.7	SECTION 112.177	112.177 Can an approved variance apply to any person other than those identified in the petition requesting that variance
21:2.0.1.1.12.15.1.8	SECTION 112.178	112.178 Under what circumstances may FDA deny a petition requesting a variance
21:2.0.1.1.12.15.1.9	SECTION 112.179	112.179 When does a variance approved by FDA become effective
21:2.0.1.1.12.15.1.10	SECTION 112.180	112.180 Under what circumstances may FDA modify or revoke an approved variance
21:2.0.1.1.12.15.1.11	SECTION 112.181	112.181 What procedures apply if FDA determines that an approved variance should be modified or revoked
21:2.0.1.1.12.15.1.12	SECTION 112.182	112.182 What are the permissible types of variances that may be granted

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