Page:United States Statutes at Large Volume 123.djvu/1858

 123STA T . 1 8 38 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9(B)byinsert in g‘ ‘ ,a n d at o ba c co p rod u ct intended f ore x port s h a l lnotbedee m edtobein v iolation of section 906 (e), 90 7 ,9 1 1,or9 2 0(a), ’ ’ before ‘‘if it — ’’ and ( 3 ) by adding at the end the follo w ing ‘‘(p)(1) N ot later than 36 months after the date of enactment of the F amily S mo k ing P revention and T obacco C ontrol A ct, and annually thereafter, the Secretary shall submit to the Committee on H ealth, E ducation, L abor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of R epresenta - tives, a report regarding— ‘‘(A) the nature, extent, and destination of U nited States tobacco product exports that do not conform to tobacco product standards established pursuant to this Act; ‘‘(B) the public health implications of such exports, including any evidence of a negative public health impact; and ‘‘(C) recommendations or assessments of policy alternatives available to Congress and the executive branch to reduce any negative public health impact caused by such exports . ‘‘(2) The Secretary is authori z ed to establish appropriate information disclosure re q uirements to carry out this subsection.’’. (m) S ECTION 1003.—Section 1003(d)(2)(C) (as redesignated by section 101(b)) is amended— (1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and (2) inserting ‘‘, and tobacco products’’ after ‘‘devices’’. (n) SECTION 1009.—Section 1009(b) (as redesignated by section 101(b)) is amended by striking ‘‘section 90 8 ’’ and inserting ‘‘section 1008’’. (o) SECTION 4 09O F T H EFE D E RALM EAT I N SP ECTION ACT.— Section 409(a) of the Federal Meat Inspection Act (21 U.S.C. 679(a)) is amended by striking ‘‘section 902(b)’’ and inserting ‘‘section 1002(b)’’. (p) R U LE OF CONSTRUCTION.—Nothing in this section is intended or shall be construed to expand, contract, or otherwise modify or amend the existing limitations on State government authority over tribal restricted fee or trust lands. (q) G UIDANCE AND EFFECTI V E D ATES.— (1) IN G ENERAL.—The Secretary of Health and Human Services shall issue guidance— (A) defining the term ‘‘repeated violation’’, as used in section 303(f)(8) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(8)) as amended by subsection (c), as including at least 5 violations of particular requirements over a 36-month period at a particular retail outlet that constitute a repeated violation and providing for civil pen- alties in accordance with paragraph (2); (B) providing for timely and effective notice by certified or registered mail or personal delivery to the retailer of each alleged violation at a particular retail outlet prior to conducting a followup compliance check, such notice to be sent to the location specified on the retailer’s registra- tion or to the retailer’s registered agent if the retailer has provider such agent information to the Food and Drug Administration prior to the violation; (C) providing for a hearing pursuant to the procedures established through regulations of the Food and Drug Administration for assessing civil money penalties, 21USC3 33 note. 21 USC 331 note. 21USC3 9 9. 21 USC 393. R e quir e m ent s . D e adl ine. Re p orts.