[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: 21CFR314.98] [Page 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. 314.98 Postmarketing reports. (a) Except as provided in paragraph (b) of this section, each applicant having an approved abbreviated new drug application under Sec. 314.94 that is effective shall comply with the requirements of Sec. 314.80 regarding the reporting and recordkeeping of adverse drug experiences. (b) Each applicant shall submit one copy of each report required under Sec. 314.80 to the Division of Epidemiology and Surveillance (HFD- 730), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. (c) Each applicant shall make the reports required under Sec. 314.81 and section 505(k) of the act for each of its approved abbreviated applications. [57 FR 17983, Apr. 28, 1992, as amended at 64 FR 401, Jan. 5, 1999]