Subpart P. Subpart P—Variances

• § 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?