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Code · CFR · Title 21 — Food and Drugs · Part 1 — General Enforcement Regulations · § 1.934

§ 1.934. What procedures apply if we determine that a waiver should be modified or revoked?

126 words·~1 min read·/us/cfr/t21/s§ 1.934

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(a)We will provide the following notifications:
(1)We will notify the entity that initially requested the waiver, in writing at the address identified in its petition, if we determine that a waiver granted in response to its petition should be modified or revoked.
(2)We will publish a notice of our determination that a waiver should be modified or revoked in the Federal Register. This notice will establish a public docket so that interested parties may submit written submissions on our determination.
(b)We will consider timely written submissions submitted to the public docket from interested parties.
(c)We will publish a notice of our decision in the Federal Register. The effective date of the decision will be the date of publication of the notice.
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