[Code of Federal Regulations] [Title 21, Volume 5] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR314.96] [Page 136-137] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--Continued PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG--Table of Contents Subpart C--Abbreviated Applications Sec. 314.96 Amendments to an unapproved abbreviated application. (a) Abbreviated new drug application. (1) An applicant may amend an abbreviated new drug application that is submitted under Sec. 314.94, but not yet approved, to revise existing information or provide additional information. (2) Submission of an amendment containing significant data or information constitutes an agreement between FDA and the applicant to extend the review period only for the time necessary to review the significant data or information and for no more than 180 days. (3) Submission of an amendment containing significant data or information to resolve deficiencies in the application as set forth in a not approvable letter issued under Sec. 314.120 constitutes an agreement between FDA and the applicant under section 505(j)(4)(A) of the act to extend the date by which the agency is required to reach a decision [[Page 137]] on the abbreviated new drug application only for the time necessary to review the significant data or information and for no more than 180 days. (b) The applicant shall submit a field copy of each amendment to Sec. 314.94(a)(9). The applicant, other than a foreign applicant, shall include in its submission of each such amendment to FDA a statement certifying that a field copy of the amendment has been sent to the applicant's home FDA district office. [57 FR 17983, Apr. 28, 1992, as amended at 58 FR 47352, Sept. 8, 1993; 64 FR 401, Jan. 5, 1999]