136 
‘‘(A) For fiscal year 2009, $85,000,000 
(subject to subsection (e)). 
‘‘(B) For fiscal year 2010, $235,000,000. 
‘‘(C) For fiscal year 2011, $450,000,000. 
‘‘(D) For fiscal year 2012, $477,000,000. 
‘‘(E) For fiscal year 2013, $505,000,000. 
‘‘(F) For fiscal year 2014, $534,000,000. 
‘‘(G) For fiscal year 2015, $566,000,000. 
‘‘(H) For fiscal year 2016, $599,000,000. 
‘‘(I) For fiscal year 2017, $635,000,000. 
‘‘(J) For fiscal year 2018, $672,000,000. 
‘‘(K) For fiscal year 2019 and each subse-
quent fiscal year, $712,000,000. 
‘‘(2) ALLOCATIONS OF ASSESSMENT BY CLASS 
OF TOBACCO PRODUCTS.— 
‘‘(A) IN GENERAL.—The total user fees as-
sessed and collected under subsection (a) each 
fiscal year with respect to each class of tobacco 
products shall be an amount that is equal to 
the applicable percentage of each class for the 
fiscal year multiplied by the amount specified in 
paragraph (1) for the fiscal year. 
‘‘(B) APPLICABLE PERCENTAGE.— 
‘‘(i) IN
GENERAL.—For purposes of 
subparagraph (A), the applicable percent-
137 
age for a fiscal year for each of the fol-
lowing classes of tobacco products shall be 
determined in accordance with clause (ii): 
‘‘(I) Cigarettes. 
‘‘(II) Cigars, including small ci-
gars and cigars other than small ci-
gars. 
‘‘(III) Snuff. 
‘‘(IV) Chewing tobacco. 
‘‘(V) Pipe tobacco. 
‘‘(VI) Roll-your-own tobacco. 
‘‘(ii) ALLOCATIONS.—The applicable 
percentage of each class of tobacco product 
described in clause (i) for a fiscal year 
shall be the percentage determined under 
section 625(c) of Public Law 108–357 for 
each such class of product for such fiscal 
year. 
‘‘(iii) REQUIREMENT
OF
REGULA-
TIONS.—Notwithstanding clause (ii), no 
user fees shall be assessed on a class of to-
bacco products unless such class of tobacco 
products is listed in section 901(b) or is 
deemed by the Secretary in a regulation
138 
under section 901(b) to be subject to this 
chapter. 
‘‘(iv) REALLOCATIONS.—In the case 
of a class of tobacco products that is not 
listed in section 901(b) or deemed by the 
Secretary in a regulation under section 
901(b) to be subject to this chapter, the 
amount of user fees that would otherwise 
be assessed to such class of tobacco prod-
ucts shall be reallocated to the classes of 
tobacco products that are subject to this 
chapter in the same manner and based on 
the same relative percentages otherwise de-
termined under clause (ii). 
‘‘(3) DETERMINATION OF USER FEE BY COM-
PANY.— 
‘‘(A) IN GENERAL.—The total user fee to 
be paid by each manufacturer or importer of a 
particular class of tobacco products shall be de-
termined for each quarter by multiplying— 
‘‘(i) such manufacturer’s or importer’s 
percentage share as determined under 
paragraph (4); by 
‘‘(ii) the portion of the user fee 
amount for the current quarter to be as-
139 
sessed on all manufacturers and importers 
of such class of tobacco products as deter-
mined under paragraph (2). 
‘‘(B) NO FEE IN EXCESS OF PERCENTAGE 
SHARE.—No manufacturer or importer of to-
bacco products shall be required to pay a user 
fee in excess of the percentage share of such 
manufacturer or importer. 
‘‘(4) ALLOCATION
OF
ASSESSMENT
WITHIN 
EACH CLASS OF TOBACCO PRODUCT.—The percent-
age share of each manufacturer or importer of a 
particular class of tobacco products of the total user 
fee to be paid by all manufacturers or importers of 
that class of tobacco products shall be the percent-
age determined for purposes of allocations under 
subsections (e) through (h) of section 625 of Public 
Law 108–357. 
‘‘(5) 
ALLOCATION
FOR
CIGARS.—Notwith-
standing paragraph (4), if a user fee assessment is 
imposed on cigars, the percentage share of each 
manufacturer or importer of cigars shall be based on 
the excise taxes paid by such manufacturer or im-
porter during the prior fiscal year. 
‘‘(6) TIMING OF ASSESSMENT.—The Secretary 
shall notify each manufacturer and importer of to-
142 
chapter and the Family Smoking Prevention 
and Tobacco Control Act. No fees collected 
under subsection (a) may be used for any other 
costs. 
‘‘(B) 
PROHIBITION
AGAINST
USE
OF 
OTHER FUNDS.— 
‘‘(i) IN
GENERAL.—Except as pro-
vided in clause (ii), fees collected under 
subsection (a) are the only funds author-
ized to be made available for the purpose 
described in subparagraph (A). 
‘‘(ii) STARTUP
COSTS.—Clause (i) 
does not apply until the date on which the 
Secretary has collected fees under sub-
section (a) for 2 fiscal year quarters. Until 
such date, other amounts available to the 
Food and Drug Administration (excluding 
fees collected under subsection (a)) are au-
thorized to be made available to pay the 
costs described in subparagraph (A), pro-
vided that such amounts are reimbursed 
through fees collected under subsection (a). 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
For fiscal year 2009 and each subsequent fiscal 
year, there is authorized to be appropriated for fees
143 
under this section an amount equal to the amount 
specified in subsection (b)(1) for the fiscal year. 
‘‘(d) COLLECTION OF UNPAID FEES.—In any case 
where the Secretary does not receive payment of a fee as-
sessed under subsection (a) within 30 days after it is due, 
such fee shall be treated as a claim of the United States 
Government subject to subchapter II of chapter 37 of title 
31, United States Code. 
‘‘(e) APPLICABILITY TO FISCAL YEAR 2009.—If the 
date of enactment of the Family Smoking Prevention and 
Tobacco Control Act occurs during fiscal year 2009, the 
following applies, subject to subsection (c): 
‘‘(1) The Secretary shall determine the fees 
that would apply for a single quarter of such fiscal 
year according to the application of subsection (b) to 
the amount specified in paragraph (1)(A) of such 
subsection (referred to in this subsection as the 
‘quarterly fee amounts’). 
‘‘(2) For the quarter in which such date of en-
actment occurs, the amount of fees assessed shall be 
a pro rata amount, determined according to the 
number of days remaining in the quarter (including 
such date of enactment) and according to the daily 
equivalent of the quarterly fee amounts. Fees as-
144 
sessed under the preceding sentence shall not be col-
lected until the next quarter. 
‘‘(3) For the quarter following the quarter to 
which paragraph (2) applies, the full quarterly fee 
amounts shall be assessed and collected, in addition 
to collection of the pro rata fees assessed under 
paragraph (2).’’. 
SEC. 102. FINAL RULE. 
(a) CIGARETTES AND SMOKELESS TOBACCO.— 
(1) IN GENERAL.—On the first day of publica-
tion of the Federal Register that is 180 days or 
more after the date of enactment of this Act, the 
Secretary of Health and Human Services shall pub-
lish in the Federal Register a final rule regarding 
cigarettes and smokeless tobacco, which— 
(A) is deemed to be issued under chapter 
9 of the Federal Food, Drug, and Cosmetic 
Act, as added by section 101 of this Act; and 
(B) shall be deemed to be in compliance 
with all applicable provisions of chapter 5 of 
title 5, United States Code, and all other provi-
sions of law relating to rulemaking procedures. 
(2) CONTENTS OF RULE.—Except as provided 
in this subsection, the final rule published under 
paragraph (1), shall be identical in its provisions to
145 
part 897 of the regulations promulgated by the Sec-
retary of Health and Human Services in the August 
28, 1996, issue of the Federal Register (61 Fed. 
Reg., 44615–44618). Such rule shall— 
(A) provide for the designation of jurisdic-
tional authority that is in accordance with this 
subsection in accordance with this Act and the 
amendments made by this Act; 
(B) strike Subpart C—Labels and section 
897.32(c); 
(C) strike paragraphs (a), (b), and (i) of 
section 897.3 and insert definitions of the terms 
‘‘cigarette’’, ‘‘cigarette tobacco,’’, and ‘‘smoke-
less tobacco’’ as defined in section 900 of the 
Federal Food, Drug, and Cosmetic Act; 
(D) insert ‘‘or roll-your-own paper’’ in sec-
tion 897.34(a) after ‘‘other than cigarettes or 
smokeless tobacco’’; 
(E) become effective on the date that is 1 
year after the date of enactment of this Act; 
and 
(F) amend paragraph (d) of section 897.16 
to read as follows: 
‘‘(d)(1) Except as provided in subparagraph (2), no 
manufacturer, distributor, or retailer may distribute or
146 
cause to be distributed any free samples of cigarettes, 
smokeless tobacco, or other tobacco products (as such 
term is defined in section 201 of the Federal Food, Drug, 
and Cosmetic Act). 
‘‘(2)(A) Subparagraph (1) does not prohibit a manu-
facturer, distributor, or retailer from distributing or caus-
ing to be distributed free samples of smokeless tobacco 
in a qualified adult-only facility. 
‘‘(B) This subparagraph does not affect the authority 
of a State or local government to prohibit or otherwise 
restrict the distribution of free samples of smokeless to-
bacco. 
‘‘(C) For purposes of this paragraph, the term ‘quali-
fied adult-only facility’ means a facility or restricted area 
that— 
‘‘(i) requires each person present to provide to 
a law enforcement officer (whether on or off duty) 
or to a security guard licensed by a governmental 
entity government-issued identification showing a 
photograph and at least the minimum age estab-
lished by applicable law for the purchase of smoke-
less tobacco; 
‘‘(ii) does not sell, serve, or distribute alcohol; 
‘‘(iii) is not located adjacent to or immediately 
across from (in any direction) a space that is used