CFR Subpart D

CFR Subpart D
in effect

21 C.F.R. § 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 An SE Report will be considered withdrawn when FDA issues a notice stating that the SE Report has been withdrawn.

21 C.F.R. § 1107.42 Review cycles.

(a) Initial review cycle. FDA intends to review the SE Report and either communicate with the applicant as described in § 1107.40 or take an action under § 1107.44 within 90 calendar days of FDA's receipt of the SE Report, or within 90 calendar days of determining that the predicate was found to be commercially marketed (other than for test marketing) in the United States as of February 15, 2007 (if applicable), whichever is later. This 90-day period is called the “initial review cycle.” (b) Additional review cycles. If FDA issues a deficiency notification under § 1107.40(d) during the initial review cycle, FDA will stop reviewing the SE Report until it receives a response from the applicant or the timeframe specified in the notification of deficiencies for response has elapsed. If the applicant fails to respond within the time period provided in the notification of deficiency, FDA will issue an order denying marketing authorization under the criteria set forth in § 1107.48. If the applicant's response to the notification of deficiencies provides the information FDA requested, but FDA identifies additional deficiencies, FDA may issue an additional deficiency notification. Each response will begin a new 90-day review cycle. (c) Inadequate response. If the applicant's response to FDA's deficiency notification(s) does not provide the information FDA requested, or the applicant provides information but the SE Report is still deficient, FDA generally intends to issue an order denying market authorization under the criteria set forth in § 1107.48. At any time before FDA issues an order, an applicant may make a written request to withdraw an SE Report under § 1107.22.

21 C.F.R. § 1107.44 FDA action on an SE Report.

After receipt of an SE Report, FDA will: (a) Refuse to accept the SE Report for review if it does not comply with § 1107.18 and § 1105.10 of this chapter; (b) Request additional information as provided in § 1107.40(d); (c) Issue a letter administratively closing the SE Report if it is not possible to make a determination on an SE Report; (d) Issue a letter canceling the SE Report if FDA finds the SE Report was created in error; (e) Issue an order as described in § 1107.46 finding the new tobacco product to be substantially equivalent and in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act; or (f) Issue an order as described in § 1107.48 denying marketing authorization because the new tobacco product is: (1) Not substantially equivalent to a tobacco product commercially marketed (other than for test marketing) in the United States on February 15, 2007, or (2) Not in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act.

21 C.F.R. § 1107.46 Issuance of an order finding a new tobacco product substantially equivalent.

If FDA finds that the information submitted in the SE Report establishes that the new tobacco product is substantially equivalent to a predicate tobacco product that was commercially marketed (other than for test marketing) in the United States on February 15, 2007, and finds that the new tobacco product is in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act, FDA will send the applicant an order authorizing marketing of the new tobacco product. A marketing authorization order becomes effective on the date the order is issued.

21 C.F.R. § 1107.48 Issuance of an order denying marketing authorization.

(a) General. FDA will issue an order that the new tobacco product cannot be marketed if FDA finds that: (1) The information submitted in the SE Report does not establish that the new tobacco product is substantially equivalent to a predicate tobacco product that was commercially marketed (other than for test marketing) in the United States on February 15, 2007; or (2) The new tobacco product is not in compliance with the Federal Food, Drug, and Cosmetic Act. (b) Basis for order. The order will describe the basis for denying marketing authorization.

21 C.F.R. § 1107.50 Rescission of order.

(a) Grounds for rescinding a substantially equivalent order. FDA may rescind a substantially equivalent order allowing a new tobacco product to be marketed if FDA determines that: (1) The tobacco product for which the order has been issued: (i) Does not have the same characteristics as the predicate tobacco product; or (ii) Has different characteristics and there is insufficient information demonstrating that it is not appropriate to require a premarket tobacco product application under section 910(b) of the Federal Food, Drug, and Cosmetic Act because the product does not raise different questions of public health; or (2) The SE Report (including any submitted amendments) contains an untrue statement of material fact; or (3) Concerning an SE Report that compared the new tobacco product to a tobacco product that FDA previously found substantially equivalent, (i) The predicate tobacco product relied on in the SE Report has been found ineligible because its SE Report (including any amendments) contains an untrue statement of material fact; or (ii) A predicate tobacco product on which any of the previous substantial equivalence determinations was based, going back to the original predicate tobacco product, has been found ineligible because its SE Report (including any amendments) contains an untrue statement of material fact; or (4) FDA or the applicant has removed from the market, due to a health or safety concern related to the tobacco product: (i) The predicate tobacco product on which the substantial equivalence determination is based; or (ii) A predicate tobacco product on which any of the previous substantial equivalence determinations is based, going back to the original predicate tobacco product, if the substantial equivalence SE Report compared the new tobacco product to a tobacco product that FDA previously found substantially equivalent. (b) Opportunity for a hearing. (1) Except as provided in paragraphs (b)(2) and (3) of this section, FDA will rescind an order only after notice and opportunity for a hearing under part 16 of this chapter. (2) FDA may rescind a substantially equivalent order prior to notice and opportunity for a hearing under part 16 of this chapter if it finds that there is a reasonable probability that continued marketing of the tobacco product presents a serious risk to public health. In that case, FDA will provide the manufacturer an opportunity for a hearing as soon as possible after the rescission. (3) FDA may rescind a substantially equivalent order without notice and opportunity for a hearing under part 16 of this chapter if the applicant has notified the Agency of a mistake in the application, FDA has determined that the mistake is part of the underlying scientific determination of the order which makes the order invalid, and the applicant has agreed that FDA can rescind the order without providing notice and opportunity for a hearing under part 16 of this chapter.

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