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CFR › Title 21 › Chapter I › Subchapter A › Part 60 › Subpart D › Section 60.34

21 CFR 60.34 - FDA action on petitions.

§ 60.34
FDA action on petitions.
(a) Within 90 days after FDA receives a petition filed under § 60.30(a), the agency will either deny the petition under paragraph (b) or (c) of this section or investigate and determine under § 60.36 whether the applicant acted with due diligence during the regulatory review period. FDA will publish its due diligence determination in the Federal Register, notify PTO of the due diligence determination in writing, and send copies of the notice to PTO, the applicant, and the petitioner.
(b) FDA may deny a due diligence petition without considering the merits of the petition if:
(1) The petition is not filed in accordance with § 60.30 ;
(2) The petition is not filed in accordance with § 10.20 ;
(3) The petition does not contain the information required by § 10.30 ;
(4) The petition fails to contain information or allegations upon which it may reasonably be determined that the applicant did not act with due diligence during the applicable regulatory review period; or
(5) The petition fails to allege a sufficient total amount of time during which the applicant did not exercise due diligence such that, even if the petition were granted, the petition would not affect the maximum patent extension the applicant sought in the application.

Title 21 published on 2012-04-01

no entries appear in the Federal Register after this date.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code
USC : Title 21 - FOOD AND DRUGS

§ 348 - Food additives

§ 355 - New drugs

§ 360e - Premarket approval

§ 360j - General provisions respecting control of devices intended for human use

§ 371 - Regulations and hearings

§ 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics

USC : Title 35 - PATENTS

§ 156 - Extension of patent term