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