Abbreviated New Drug Applications and 505(b)(2) Applications

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Parts 314 and 320 [Docket No. FDA-2011-N-0830] RIN 0910-AF97 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: 2. On page 6808, in Table 1, the second column should read: 3. On pages 6818-6819, in Table 2, the second row should read: 4. On pages 6838-6839, in Table 8, the second row should read: 5. On pages 6842-6843, in Table 9, the third row should read: 6. On pages 6859-6861, in Table 12, the third, sixth, and seventh rows should read: ( printed page 13290)   Proposed Changes See section of this document (identified in parentheses) for more detailed information regarding the proposed change   314.95(e) Documentation of Timely Sending and Receipt of Notice of Paragraph IV Certification, including: a. Acceptable methods of sending notice of paragraph IV certification; and b. Amendment documenting timely sending and confirmation of receipt of notice of paragraph IV certification. (II.D.4). Current regulations Proposed revisions to regulations General Requirements (§ 314.53(c)(1)) General Requirements (§ 314.53(c)(1)) 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 i…