§ 1107.40 - Communications between FDA and applicants.

§ 1107.40 Communications between FDA and applicants.

(a) General principles. During the course of reviewing an SE Report, FDA may communicate with applicants about relevant matters, including scientific, medical, and procedural issues that arise during the review process. These communications may take the form of telephone conversations, letters, or emails, and will be documented in the SE Report in accordance with § 10.65 of this chapter.

(b) Meeting. Meetings between FDA and applicants may be held to discuss scientific and other issues. Requests for meetings will be directed to the Office of Science, Center for Tobacco Products, and FDA will make every attempt to grant requests for meetings that involve important issues.

(c) Acceptance of an SE Report for review. After receiving an SE Report under § 1107.18, FDA will either refuse to accept the SE Report for review or issue an acceptance for review letter.

(d) Notification of deficiencies in an SE Report submitted under § 1107.18. FDA will make reasonable efforts to communicate to applicants the procedural, administrative, or scientific deficiencies found in an SE Report and any additional information and data needed for the Agency's review. The applicant must also provide additional comparison information under § 1107.19 if requested by FDA.

(e) Withdrawal of SE Report. An SE Report will be considered withdrawn when FDA issues a notice stating that the SE Report has been withdrawn.