21 CFR § 112.176 - What process applies to a petition requesting a variance?

§ 112.176 What process applies to a petition requesting a variance?

(a) In general, the procedures set forth in § 10.30 of this chapter govern our response to a petition requesting a variance.

(b) Under § 10.30(h)(3) of this chapter, we will publish a notice in the Federal Register, requesting information and views on a filed petition, including information and views from persons who could be affected by the variance if the petition were to be granted (e.g., because their farm is covered by the petition or as a person similarly situated to persons covered by the petition).

(c) Under § 10.30(e)(3) of this chapter, we will respond to the petitioner in writing and will also make public a notice on FDA's Web site announcing our decision to either grant or deny the petition.

(1) If we grant the petition, either in whole or in part, we will specify the persons to whom the variance applies and the provision(s) of this part to which the variance applies.

(2) If we deny the petition (including partial denials), our written response to the petitioner and our public notice announcing our decision to deny the petition will explain the reason(s) for the denial.

(d) We will make readily accessible to the public, and periodically update, a list of filed petitions requesting variances, including the status of each petition (for example, pending, granted, or denied).

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