Subpart P—Variances

Sections

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