Re: FDA Administrative Procedure Act

An administrative file is to be prepared for all matters subject to the APA. That file can be obtained under agency provisions or the FOIA. The administrative file shall contain all related documentation including relevant

evaluations, reviews, memoranda, letters, opinions of consultants, minutes of meetings,

records of private communications between FDA employees and those outside the agency,

and all other written material pertinent to the matter as required by 21 CFR 10.70. Please note that this does not include copies of Action Memoranda, Strategy Documents, other internal

working papers, or distribution and concurrences. Entry upon the Federal Register is then required and enforcement/implementation then applies. FDA has various agency related requirements. Should you require assistance with Rx related matters, contact an attorney for assistance.

Re: FDA Administrative Procedure Act

Also note that the Administrative Practices and Procedures allows for administrative reconsideration of action. The Commissioner may, at any time, reconsider a matter, on the

Commissioner`s own initiative or on the petition of an interested person. Deference will be given to agency determinations in a judicial action. The timeliness for administrative action is no later than 30 days after the date of the decision involved. Good cause requirements apply. The Commissioner may, for

good cause, permit a petition to be filed after 30 days. In the case of a decision published in the Federal Register, the day of publication is

the day of decision. Hope this helps.

Re: FDA Administrative Procedure Act

The following may help:

First, in the absence of a statutorily defined standard of review for actions under the FDA, the Administrative Procedure Act (APA) supplies the applicable standard. 5 U.S.C. §§ 701(a), 706(2)(A).

5 U.S.C.A. § 706 Scope of review, states:

To the extent necessary to decision and when presented, the reviewing court shall decide all relevant questions of law, interpret constitutional and statutory provisions, and determine the meaning or applicability of the terms of an agency action. The reviewing court shall--

(1) compel agency action unlawfully withheld or unreasonably delayed; and

(2) hold unlawful and set aside agency action, findings, and conclusions found to be--

(A) arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law;

(B) contrary to constitutional right, power, privilege, or immunity;

(C) in excess of statutory jurisdiction, authority, or limitations, or short of statutory right;

(D) without observance of procedure required by law;

(E) unsupported by substantial evidence in a case subject to sections 556 and 557 of this title or otherwise reviewed on the record of an agency hearing provided by statute; or

(F) unwarranted by the facts to the extent that the facts are subject to trial de novo by the reviewing court.

In making the foregoing determinations, the court shall review the whole record or those parts of it cited by a party, and due account shall be taken of the rule of prejudicial error.

Second, in Florida, "an administrative agency is afforded wide discretion in the interpretation of a statute which it is given the power and duty to administer," and that an agency's interpretation of such a statute "will not be overturned on appeal unless it is clearly erroneous." Republic Media, Inc. v. Dep't of Transp., 714 So.2d 1203, 1205 (Fla. 5th DCA 1998). This deferential standard of review requires that we uphold an agency's statutory interpretation if it "is within the range of possible and reasonable" interpretations. Id.; see also Fla. Dep't of Educ. v. Cooper, 858 So.2d 394 (Fla. 1st DCA 2003). It does not require that we defer to an implausible and unreasonable statutory interpretation adopted by an administrative agency. D.T. v. Harter, 844 So.2d 717 (Fla. 2d DCA 2003).

CASE: Office of Fire Code Official of Collier County Fire Control and Rescue Districts v. Florida Dept. of Financial Services 2004 WL 625641, *4 (Fla.App. 2 Dist.) to 2004 WL 625641, *5 (Fla.App. 2 Dist. 2004)