123STA T . 1 8 2 6PUBLIC LA W 111 – 31 —J U NE 22 , 2 0 0 9‘ ‘ (2)considerap pro v in gth ee x tended u seo f nicotine rep l ace -m ent products (such as nicotine patches , nicotine gum, and nicotine lo z enges) for the treatment of to b acco dependence
and ‘‘( 3 ) revie w and consider the evidence for additional indica- tions for nicotine replacement products, such as for craving relief or relapse prevention . ‘‘(b) REPORT O NI NNO VA T I VE P RO DUC T S . — ‘‘( 1 )IN G ENERA L .— N ot later than 3 y ears after the date of enactment of the F amily S mo k ing Prevention and T obacco C ontrol A ct, the Secretary, after consultation with recognized scientific, medical, and public health experts (including both Federal agencies and nongovernmental entities, the Institute of M edicine of the National Academy of Sciences, and the Society for Research on Nicotine and Tobacco), shall submit to the Congress a report that examines how best to regulate, promote, and encourage the development of innovative products and treatments (including nicotine-based and non-nicotine- based products and treatments) to better achieve, in a manner that best protects and promotes the public health— ‘‘(A) total abstinence from tobacco use; ‘‘( B ) reductions in consumption of tobacco; and ‘‘(C) reductions in the harm associated with continued tobacco use. ‘‘(2) RECO M MENDATIONS.—The report under paragraph (1) shall include the recommendations of the Secretary on how the Food and D rug Administration should coordinate and facili- tate the exchange of information on such innovative products and treatments among relevant offices and centers within the Administration and within the National Institutes of H ealth, the Centers for Disease Control and Prevention, and other relevant agencies. ‘ ‘ SEC.91 9. U SE RF EES. ‘‘(a) E STA B LIS H MENT O FQ UARTERL Y FEE.—Beginning on the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary shall in accordance with this section assess user fees on, and collect such fees from, each manufacturer and importer of tobacco products sub j ect to this chapter. The fees shall be assessed and collected with respect to each q uarter of each fiscal year, and the total amount assessed and collected for a fiscal year shall be the amount specified in subsection (b)(1) for such year, subject to subsection (c). ‘‘(b) ASSESSMENT OF U SER FEE.— ‘‘(1) AMOUNT OF ASSESSMENT.—The total amount of user fees authorized to be assessed and collected under subsection (a) for a fiscal year is the following, as applicable to the fiscal year involved
‘‘(A) For fiscal year 2 0 0 9 , $85 ,000,000 (subject to sub- section (e)). ‘‘(B) For fiscal year 2010, $235,000,000. ‘‘(C) For fiscal year 2011, $ 4 50,000,000. ‘‘(D) For fiscal year 2012, $4 7 7,000,000. ‘‘(E) For fiscal year 2013, $505,000,000. ‘‘(F) For fiscal year 2014, $534,000,000. ‘‘( G ) For fiscal year 2015, $5 6 6,000,000. ‘‘(H) For fiscal year 2016, $599,000,000. Ef f ectiv e da te .21USC387s .
