21 CFR Subpart P
Variances
June 25, 2020
§
112.171
Who may request a variance from the requirements of this part?
§
112.172
How may a State, tribe, or foreign country request a variance from one or more requirements of this part?
§
112.173
What must be included in the Statement of Grounds in a petition requesting a variance?
§
112.174
What information submitted in a petition requesting a variance or submitted in comments on such a petition are publicly available?
§
112.175
Who responds to a petition requesting a variance?
§
112.176
What process applies to a petition requesting a variance?
§
112.177
Can an approved variance apply to any person other than those identified in the petition requesting that variance?
§
112.178
Under what circumstances may FDA deny a petition requesting a variance?
§
112.179
When does a variance approved by FDA become effective?
§
112.180
Under what circumstances may FDA modify or revoke an approved variance?
§
112.181
What procedures apply if FDA determines that an approved variance should be modified or revoked?
§
112.182
What are the permissible types of variances that may be granted?
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