Proposed SEC 507.67(b) would establish that submission of an appeal, including submission of a request for an informal hearing, will not delay or stay any administrative action, including enforcement action by FDA, unless the Commissioner of Food and Drugs, as a matter of discretion, determines that delay or a stay is in the public interest. For example, the submission of an appeal of a withdrawal order with a request for an informal hearing under proposed SEC 507.67(b) would not prevent FDA from simultaneously detaining animal food from the facility under section 304(h) of the FD&C Act, seizing animal food from the facility under section 304(a) of the FD&C Act, or seeking or enforcing an injunction under section 302 of the FD&C Act.
Proposed SEC 507.67(c) would require that, if the owner, operator, or agent in charge of the qualified facility appeals the order, and FDA confirms the order, the owner, operator, or agent in charge of the facility must comply with applicable requirements of this part within 60 calendar days of the date of the order. Proposed SEC 507.67(c) would make clear that the 60 calendar day timeframe for compliance applies regardless of whether the owner, operator, or agent in charge of a facility requests, and FDA grants, a hearing. As already discussed, FDA tentatively concludes that the circumstances that lead to a determination that an exemption should be withdrawn warrant prompt compliance in the interest of animal or human health.
F. Proposed SEC 507.69--Procedure for Submitting an Appeal
Proposed SEC 507.69(a) would require that, to appeal an order to withdraw an exemption applicable to a qualified facility under SEC 507.5(c), the owner, operator, or agent in charge of the facility must: (1) Submit the appeal in writing to the
Allowing the owner, operator, or agent in charge of the facility to submit an appeal in person, by mail, email, or fax would provide for flexibility as well as speed. For example, submitting in person would give the owner, operator, or agent in charge direct knowledge that the request for appeal had been delivered and received. Email and fax are instantaneous, and overnight mail delivery services are readily available to those who choose to use them; however, the 10 day timeframe for appeal of the order would not require the use of overnight mail delivery. For clarity, proposed SEC 507.69(a) would repeat the 10 calendar day timeframe that would be established in proposed SEC 507.67(a)(2) and would not establish any new requirement. Any appeal would need to be written in order for FDA to evaluate the basis for the appeal. The Agency is proposing that a written appeal would need to address with particularity all of the issues raised in the withdrawal order and include all supporting documentation so that the Agency would be able to issue a final determination as to the disposition of the appeal solely on the basis of the materials submitted as part of the written appeal.
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