Page:United States Statutes at Large Volume 123.djvu/1837

 123STA T . 1 8 1 7PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9‘ ‘ (4)TIME.—Anorde r is s u ed under su b se ct ion ( g )( 1 )s hal l bee f fecti v eforas p ecified period of ti m e. ‘‘( 5 )A DV E RT I S I NG .—The S ecretar y may re q uire ,w ith respect to a product for which an applicant obtained an order under subsection (g)(1), that the product comply with require - ments relating to advertising and promotion of the tobacco product. ‘‘(i) PO STM A R K ETS U RVEI L LAN C E AND STUDIES.— ‘‘(1) I N GENERAL.—The Secretary shall require, with respect to a product for which an applicant obtained an order under subsection (g)(1), that the applicant conduct postmar k et surveil- lance and studies for such a tobacco product to determine the impact of the order issuance on consumer perception, behavior, and health, to enable the Secretary to review the accuracy of the determinations upon which the order was based, and to provide information that the Secretary determines is otherwise necessary regarding the use or health risks involving the tobacco product. The results of postmarket surveillance and studies shall be submitted to the Secretary on an annual basis. ‘‘( 2 ) SURVEILLANCE P ROTOCOL.— E ach applicant required to conduct a surveillance of a tobacco product under paragraph (1) shall, within 30 days after receiving notice that the applicant is required to conduct such surveillance, submit, for the approval of the Secretary, a protocol for the required surveil- lance. The Secretary, within 6 0 days of the receipt of such protocol, shall determine if the principal investigator proposed to be used in the surveillance has sufficient qualifications and e x perience to conduct such surveillance and if such protocol will result in collection of the data or other information des- ignated by the Secretary as necessary to protect the public health. ‘‘( j ) W IT H DRA W ALO F AUTHORI Z ATION.—The Secretary, after an opportunity for an informal hearing, shall withdraw an order under subsection (g) if the Secretary determines that— ‘‘(1) the applicant, based on new information, can no longer make the demonstrations required under subsection (g), or the Secretary can no longer make the determinations required under subsection (g) ‘‘(2) the application failed to include material information or included any untrue statement of material fact; ‘‘(3) any explicit or implicit representation that the product reduces risk or exposure is no longer valid, including if— ‘‘(A) a tobacco product standard is established pursuant to section 9 0 7 ‘‘( B ) an action is taken that affects the risks presented by other commercially marketed tobacco products that were compared to the product that is the subject of the applica- tion; or ‘‘( C ) any postmarket surveillance or studies reveal that the order is no longer consistent with the protection of the public health; ‘‘(4) the applicant failed to conduct or submit the postmarket surveillance and studies required under subsection (g)(2)(C)(ii) or subsection (i); or ‘‘(5) the applicant failed to meet a condition imposed under subsection (h). Hearings.D ea dl ines. Not i c e. Deadline.