123STA T . 1 794PUBLIC LA W 111 – 31 —J U NE 22 , 2 0 09 ‘ ‘ (3)BIAN N U A LREPO R T O F AN YCH AN G EINPRO D UCT LI S T .—Eachpersonw ho re gi s t ers with the S ecretar yu n d er this section sha l l report to the Secretary once during the m onth o fJ une of each year and once during the month of D ecem b er of each year the following
‘‘( A ) A list of each tobacco product introduced by the registrant for commercial distribution which has not been included in any list pre v iously filed by that person with the Secretary under this subparagraph or paragraph ( 1 ). A list under this subparagraph shall list a tobacco product by its established name and shall be accompanied by the other information re q uired by paragraph (1). ‘‘(B) I f since the date the registrant last made a report under this paragraph that person has discontinued the manufacture , preparation, compounding, or processing for commercial distribution of a tobacco product included in a list filed under subparagraph (A) or paragraph (1), notice of such discontinuance, the date of such discontinuance, and the identity of its established name. ‘‘( C ) If since the date the registrant reported under subparagraph (B) a notice of discontinuance that person has resumed the manufacture, preparation, compounding, or processing for commercial distribution of the tobacco product with respect to which such notice of discontinuance was reported, notice of such resumption, the date of such resumption, the identity of such tobacco product by estab - lished name, and other information required by paragraph (1), unless the registrant has previously reported such resumption to the Secretary under this subparagraph. ‘‘(D) Any material change in any information previously submitted under this paragraph or paragraph (1). ‘‘( j ) R EPORT P RECEDING INTRODUCTION OF CERTAIN SU B STAN- TIALLY E Q UI V ALENT PRODUCTS INTO INTERSTATE CO M MERCE.— ‘‘(1) IN GENERAL.—Each person who is required to register under this section and who proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a tobacco product intended for human use that was not commercially mar k eted (other than for test marketing) in the U nited States as of F ebruary 1 5 , 20 0 7 , shall, at least 9 0 days prior to making such introduction or delivery, report to the Secretary (in such form and manner as the Secretary shall prescribe)— ‘‘(A) the basis for such person ’ s determination that— ‘‘(i) the tobacco product is substantially equivalent, within the meaning of section 910, to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007, or to a tobacco product that the Secretary has previously determined, pursuant to subsection (a)(3) of section 910, is substantially equivalent and that is in compli- ance with the requirements of this Act
or ‘‘(ii) the tobacco product is modified within the meaning of paragraph (3), the modifications are to a product that is commercially marketed and in compli- ance with the requirements of this Act, and all of the modifications are covered by e x emptions granted by the Secretary pursuant to paragraph (3); and Notice. Notice.
