Condition
(2) Condition means an active ingredient or botanical drug substance (or a combination of active ingredients or botanical drug substances), dosage form, dosage strength, or route of administration, marketed for a specific OTC use, except as excluded in paragraph (b)(2) of this section. (3) Date of filing means the date of the notice from FDA stating that FDA has made a threshold determination that the safety and effectiveness data submission is sufficiently complete to permit a substantive review; or, if the submission is filed over protest in accordance with paragraph (j)(3) of this section, the date of filing is the date of the notice from FDA stating that FDA has filed the submission over protest (this date will be no later than 30 days after the request that FDA file the submission over protest). (4) Feedback letter means a letter issued by the agency in accordance with paragraph (g)(4) of this section that informs the sponsor and other interested persons who have submitted data under paragraph (f) of this section that a condition is initially determined not to be generally recognized as safe and effective (GRASE). (5) Safety and effectiveness data submission means a data package submitted by a sponsor or other interested person that includes safety and effectiveness data and information under paragraph (f) of this section and that is represented by the submitter as being a complete submission. (6) Sponsor means the person that submitted a time and extent application (TEA) under paragraph (c) of this section. (7) Time and extent application (TEA) means a submission by a sponsor under paragraph (c) of this section, which will be evaluated by the agency to determine eligibility of a condition for consideration in the OTC drug monograph system.