[Code of Federal Regulations] [Title 21 Volume 5] [Revised as of April 1, 2003] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR314.120] [Page 138-139] 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 D--FDA Action on Applications and Abbreviated Applications Sec. 314.120 Not approvable letter to the applicant. (a) The Food and Drug Administration will send the applicant a not approvable letter if the agency believes that the application may not be approved for one of the reasons given in Sec. 314.125 or the abbreviated new drug application may not be approved for one of the reasons given in Sec. 314.127. The not approvable letter will describe the deficiencies in the application or abbreviated application. Except as provided in paragraph (b) of this section, within 10 days after the date of the not approvable letter, the applicant shall: (1) Amend the application or abbreviated application or notify FDA of an intent to file an amendment. The filing of an amendment or a notice of intent to file an amendment constitutes an agreement by the applicant to extend the review period under Sec. 314.60 or Sec. 314.96; (2) Withdraw the application or abbreviated application. Except as provided in paragraph (b) of this section, FDA will consider the applicant's failure to respond within 10 days to a not approvable letter to be a request by the applicant to withdraw the application under Sec. 314.65 or abbreviated application under Sec. 314.99. A decision to withdraw the application or abbreviated application is without prejudice to refiling; (3) For a new drug application or an abbreviated application, ask the agency to provide the applicant an opportunity for a hearing on the question of whether there are grounds for denying approval of the application under section 505(d) or (j)(3) of the act. The applicant shall submit the request to the Associate Director for Policy (HFD-5), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Within 60 days of the date of the not approvable letter, or within a different [[Page 139]] time period to which FDA and the applicant agree, the agency will either approve the application or abbreviated application under Sec. 314.105 or refuse to approve the application under Sec. 314.125 or abbreviated new drug application under Sec. 314.127 and give the applicant written notice of an opportunity for a hearing under Sec. 314.200 and section 505(c)(1)(B) or (j)(4)(C) of the act on the question of whether there are grounds for denying approval of the application under section 505(d) or (j)(3) of the act; or (4) [Reserved] (5) Notify FDA that the applicant agrees to an extension of the review period under section 505(c)(1) or (j)(4)(A) of the act, so that the applicant can determine whether to respond further under paragraph (a)(1), (a)(2), or (a)(3) of this section. The applicant's notice is required to state the length of the extension. FDA will honor any reasonable request for such an extension. FDA will consider the applicant's failure to respond further within the extended review period to be a request to withdraw the application under Sec. 314.65 or abbreviated application under Sec. 314.99. A decision to withdraw an application or abbreviated application is without prejudice to a refiling. (b) With the exception of a request for an opportunity for a hearing under paragraph (a)(3) of this section, the 10-day time period in this section for responding to a not approvable letter does not apply to abbreviated new drug applications. FDA may consider the applicant's failure to respond within 180 days to a not approvable letter to be a request by the applicant to withdraw the abbreviated new drug application under Sec. 314.99. [57 FR 17990, Apr. 28, 1992, as amended at 62 FR 43639, Aug. 15, 1997; 64 FR 402, Jan. 5, 1999]