§112.172. How may a State, tribe, or foreign country request a variance from one or more requirements of this part? — Inbound Citations
21 C.F.R. § 112.172
Statutory Authority
Cited by 1 regulation in release Current.
Citations to 21 C.F.R. § 112.172 as a whole
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(a) A State, tribe, or a foreign country that believes that a variance requested by a petition submitted by another State, tribe, or foreign country should also apply to similarly situated persons in its jurisdiction may request that the variance be applied to its similarly situated persons by submitting comments in accordance with § 10.30 of this chapter. These comments must include the information required in § 112.173. If FDA determines that these comments should instead be treated as a separate request for a variance, FDA will notify the State, tribe, or foreign country that submitted these comments that a separate request must be submitted in accordance with §§ 112.172 and 112.173.