§ 1114.45 - Record retention.

§ 1114.45 Record retention.

(a) Record retention by the applicant.

(1) Each applicant that receives a marketing granted order must maintain all records necessary to facilitate a determination of whether there are or may be grounds to withdraw or temporarily suspend the marketing granted order, including records related to both the application and postmarket reports, and ensure that such records remain readily available to the Agency upon request (including where records are maintained by a third party on an applicant's behalf). These records include, but are not limited to:

(i) All documents submitted to FDA as part of an application, periodic postmarket reports, and adverse experience reports;

(ii) All documentation demonstrating whether each:

(A) Nonclinical laboratory study was conducted in accordance with good laboratory practices that support the reliability of the results, such as the records described in part 58 of this chapter; and

(B) Clinical investigator has any financial conflicts of interest that may be a source of bias, such as the documentation described in part 54 of this chapter;

(iii) All other documents generated during the course of a study necessary to substantiate the study results, including:

(A) Communications related to the investigation between the investigator and the sponsor, the monitor, or FDA; and

(B) All source data for human subject and nonclinical investigations included in the application and postmarket reports, including records of each study subject's case history and exposure to tobacco products used in the investigation, including case report forms, progress notes, hospital records, clinical charts, X-rays, lab reports, and subject diaries; and

(iv) A list of each complaint, and a summary and analysis of all complaints, associated with the tobacco product reported to the applicant;

(2) These records must be legible, in the English language, and available for inspection and copying by officers or employees duly designated by the Secretary. Documents that have been translated from another language into English (e.g., original study documents written in a language other than English) must be accompanied by the original language version of the document, a signed statement by an authorized representative of the manufacturer certifying that the English language translation is complete and accurate, and a brief statement of the qualifications of the person that made the translation.

(3) All records must be retained as follows:

(i) Records related to and including the PMTA must be retained for a period of at least 4 years from the date that the marketing granted order is issued.

(ii) Records related to postmarket reports, including both periodic and adverse experience reports, must be retained for a period of at least 4 years from the date the report was submitted to FDA or until FDA inspects the records, whichever occurs sooner.

(b) Record retention by FDA. FDA will retain information submitted to it in accordance with Federal Agency Records schedules and will provide a copy to persons to whom such information may legally be disclosed on request under the fee schedule in FDA's public information regulations in § 20.45 of this chapter.