# Abbreviated New Drug Applications and 505(b)(2) Applications
**Correction**
In Proposed Rule Document 2015-01666, pages 6801-6896, publishing in the Issue of Friday, February 6, 2015, make the following corrections:
1. On page 6807, in the second column in Table 1, the heading should read:
| | Proposed Changes |
| --- | --- |
| | |
2. On page 6808, in Table 1, the second column should read:
| | |
| --- | --- |
| 314.95(e) | Documentation of Timely Sending and Receipt of Notice of Paragraph IV Certification, including: |
3. On pages 6818-6819, in Table 2, the second row should read:
| Current regulations | Proposed revisions to regulations |
| --- | --- |
| | |
| Patent information will not be accepted unless it is complete and submitted on the appropriate forms (Form FDA 3542a or 3542) | • Patent information will not be accepted unless it is submitted on the appropriate forms (Form FDA 3542a or 3542) and contains the information required in § 314.53(c)(2). |
| | |
| The required information and verification in § 314.53(c)(2)(i) and (c)(2)(ii) includes: | The required information and verification in § 314.53(c)(2)(i) and (c)(2)(ii) includes: |
4. On pages 6838-6839, in Table 8, the second row should read:
| Current regulations | Proposed revisions to regulations |
| --- | --- |
| | |
| • Applicant must amend its 505(b)(2) application or ANDA to document the date of receipt of the notice of paragraph IV certification by each patent owner and NDA holder provided the notice. | • Applicant must amend its 505(b)(2) application or ANDA to provide documentation of the date of receipt of the notice of paragraph IV certification by each patent owner and NDA holder provided the notice. |
| | • Amendment also must include adequate documentation that notice was sent on a date that complies with the timeframe required by § 314.52(b) or (d) or § 314.95(b) or (d), as applicable. |
| | —FDA will accept a copy of the registered mail receipt, certified mail receipt, or receipt from a designated delivery service, as adequate documentation of the date of delivery. |
| | • An ANDA applicant's amendment must include a dated printout of the Orange Book entry for the RLD that includes the patent that is the subject of the paragraph IV certification. |
| | • An applicant may rely on another form of documentation only if FDA has agreed in advance. |
5. On pages 6842-6843, in Table 9, the third row should read:
| Current regulations | Proposed revisions to regulations |
| --- | --- |
| | |
| • Change from paragraph IV certification to paragraph III certification required after a final judgment is entered finding the patent to be infringed. | • Change from paragraph IV certification to paragraph III certification required after court enters final decision from which no appeal has been or can be taken, or signs settlement order or consent decree with a finding of infringement (unless the patent also is found invalid). An applicant may instead provide a statement under § 314.50(i)(1)(iii) or § 314.94(a)(12)(iii) with respect to a method-of-use patent if the 505(b)(2) application or ANDA is amended such that the applicant is no longer seeking approval for a method of use claimed by the patent. |
6. On pages 6859-6861, in Table 12, the third, sixth, and seventh rows should read:
| Current regulations | Proposed revisions to regulations |
| --- | --- |
| | |
| • Except as provided in § 314.107(b)(3), (b)(4), and (c), approval will become effective on the date FDA issues an approval letter if the applicant certifies that: | • If none of the reasons in § 314.125 or § 314.127 for refusing to approve the application apply, and none of the reasons in § 314.107(d) for delaying approval apply, the 505(b)(2) application or ANDA may be approved— |
| | (D) there are no relevant patents. |
| | |
| • (A) Except as provided in § 314.107(b)(3)(ii) through (b)(3)(iv), if | • (A) Except as provided in § 314.107(b)(3)(ii) through (b)(3)(viii), if, with respect to patents for which required information was submitted before the date on which the 505(b)(2) application or ANDA was submitted to FDA (excluding an amendment or supplement), |
| | |
| If before the expiration of the 30-month period, or 7
years where applicable: | If before the expiration of the 30-month period, or 7
years where applicable: |
| | • (v) the district court grants a preliminary injunction prohibiting the applicant from engaging in the commercial manufacture or sale of the drug product until the court decides the issues of patent validity and infringement: |
| | — if the court later decides the patent is invalid, unenforceable, or not infringed, the 505(b)(2) application or ANDA may be approved per § 314.107(b)(3)(ii). |
| | —if the court decides that the patent has been infringed, the 505(b)(2) application or ANDA may be approved per § 314.107(b)(3)(iii) or (b)(3)(iv), as applicable. |
| | • (vi) the patent owner or the exclusive patent licensee (or their representatives) agrees in writing that the 505(b)(2) application or ANDA may be approved any time on or after the date of the consent, approval may be granted on or after that date. |
| | • (vii) the court enters an order requiring the 30-month or 7
-year period to be terminated, the 505(b)(2) application or ANDA may be approved in accordance with the court's order. |
| | • (viii) the court enters an order of dismissal, with or without prejudice, without a finding of infringement, the 505(b)(2) application or ANDA may be approved on or after the date of the order. |