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Code of Federal Regulations

Subpart P

Variances

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