See also 81 FR 69580 at 69620-21 (October 16, 2016). 6 See section 505(j)(2)(C) of the FD&C Act and 21 CFR 314.93. 7 See section 505(j)(2)(A) and 505(j)(2)(C) of the FD&C Act and 21 CFR 314.

21 C.F.R. § 314.60 Patent certification requirements (§ 314.60(f))Requires that if an amendment the 505(b)(2) application does not contain a patent certification or statement, the applicant must verify that the proposed change described in the amendment is not: (1) A new indication or other condition of use; (2) a new strength. (3) an other-than-minor change in product formulation; or (4) a change to the physical form or crystalline structure of the active ingredient (see section VF.1).21 C.F.R. § 314.70Patent certification requirements (§ 314.70(i))Omits proposed § 314 70(i) on patent certification requirements for 505(b)(2) supplements, which is not being finalized at this time (see section V.F.2).21 C.F.R. § 314.90 Waivers (§ 314.90)No substantive changes from the proposed rule (see section V.L.).21 C.F.R. § 314.93 Petition to request a change from a listed drug (§ 314.93)No substantive changes from the proposed rule (see section V.I).21 C.F.R. § 314.94 Method-of-use patent (§ 314.94(a)(12)(iii)(A))Clarifies that an ANDA applicant may submit a statement under section 505(j)(2)(A)(viii) of the FD&C Act if the applicant is not seeking approval for “an” indication or other condition of use claimed by a method-of-use patent rather than “any” indications or other conditions of use claimed by the method-of-use patent (see section V.C.1).Untimely filing of patent information (§ 314.94(a)(12)(vi))Provides that an amendment to the description of the approved method(s) of use claimed by the patent will not be considered untimely filing of patent information if the amendment is submitted within 30 days of a decision by the USPTO or a Federal court that is specific to the patent and alters the construction of a method-of-use claim(s) o f the patent, and the amendment contains a copy of the decision (see sec

Heck, FDA has not even updated the Agency’s ANDA Suitability Petition Tracking Reports since August 2015!Perhaps as a result of FDA’s failure to timely address suitability petitions, Congress expressed its expectation that FDA meet this 90-day target in Section 805 of the 2017 Food and Drug Administration Reauthorization Act (“FDARA”). In addition to a “sense of Congress” provision stating that FDA “shall meet the requirement under [FDC Act § 5050)(2)(C)] and [21 C.F.R. § 314.93(e)] of responding to suitability petitions within 90 days of submission,” Congress hoped to encourage FDA to expedite responses to such petitions by requiring a report of the number of outstanding suitability petitions and a report of the number of suitability petitions that remained outstanding 180 days after submission. FDARA § 805.

As FDA explained in a 2004 citizen petition response (page 9, note 13):if a tablet and a capsule are approved for the same moiety with patents listed for the tablet and none listed for the capsule, an ANDA applicant seeking approval for a tablet should cite the approved tablet as the [RLD]. It should not circumvent the patents on the tablet by citing the capsule as the [RLD] and filing a suitability petition under [FDC Act § 505(j)(2)(C)] and 21 CFR 314.93 seeking to change to a tablet dosage form.Under FDA's longstanding RLD Change Policy, the Agency has required a generic applicant with a pending ANDA subject to an approved suitability petition to change RLD and provide appropriate bioequivalence information once the Agency approved an application for the drug product covered by the suitability petition. For example, after FDA approved NDAs for Carboplatin Injection drug products that were also the subject of pending ANDAs submitted pursuant to an approved suitability petition, the Agency required generic applicants to change RLD. FDA has also required generic applicants to take the same action in an Rx-to-OTC switch scenario, where the Agency approved a new NDA for an OTC drug product - thus creating a new RLD listed in the Orange Book to which generic applicant must cite.