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HR 1108 RFS 
‘‘(A) the manufacturer has submitted the 
required products for testing to a laboratory 
and has done so sufficiently in advance of the 
deadline to create a reasonable expectation of 
completion by the deadline; 
‘‘(B) the products currently are awaiting 
testing by the laboratory; and 
‘‘(C) neither that laboratory nor any other 
laboratory is able to complete testing by the 
deadline at customary, nonexpedited testing 
fees. 
‘‘(3) EXTENSION.—The Secretary, taking into 
account the laboratory testing capacity that is avail-
able to tobacco product manufacturers, shall review 
and verify the evidence submitted by a small tobacco 
product manufacturer in accordance with paragraph 
(2). If the Secretary finds that the conditions de-
scribed in such paragraph are met, the Secretary 
shall notify the small tobacco product manufacturer 
that the manufacturer shall not be considered to be 
in violation of the testing and reporting require-
ments of this section until the testing is reported or 
until 1 year after the reporting deadline has passed, 
whichever occurs sooner. If, however, the Secretary 
has not made a finding before the reporting dead-
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HR 1108 RFS 
line, the manufacturer shall not be considered to be 
in violation of such requirements until the Secretary 
finds that the conditions described in paragraph (2) 
have not been met, or until 1 year after the report-
ing deadline, whichever occurs sooner. 
‘‘(4) ADDITIONAL EXTENSION.—In addition to 
the time that may be provided under paragraph (3), 
the Secretary may provide further extensions of 
time, in increments of no more than 1 year, for re-
quired testing and reporting to occur if the Sec-
retary determines, based on evidence properly and 
timely submitted by a small tobacco product manu-
facturer in accordance with paragraph (2), that a 
lack of available laboratory capacity prevents the 
manufacturer from completing the required testing 
during the period described in paragraph (3). 
‘‘(f) RULE
OF CONSTRUCTION.—Nothing in sub-
section (d) or (e) shall be construed to authorize the exten-
sion of any deadline, or to otherwise affect any timeframe, 
under any provision of this Act or the Family Smoking 
Prevention and Tobacco Control Act other than this sec-
tion. 
‘‘SEC. 916. PRESERVATION OF STATE AND LOCAL AUTHOR-
ITY. 
‘‘(a) IN GENERAL.— 
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HR 1108 RFS 
‘‘(1) PRESERVATION.—Except as provided in 
paragraph (2)(A), nothing in this chapter, or rules 
promulgated under this chapter, shall be construed 
to limit the authority of a Federal agency (including 
the Armed Forces), a State or political subdivision 
of a State, or the government of an Indian tribe to 
enact, adopt, promulgate, and enforce any law, rule, 
regulation, or other measure with respect to tobacco 
products that is in addition to, or more stringent 
than, requirements established under this chapter, 
including a law, rule, regulation, or other measure 
relating to or prohibiting the sale, distribution, pos-
session, exposure to, access to, advertising and pro-
motion of, or use of tobacco products by individuals 
of any age, information reporting to the State, or 
measures relating to fire safety standards for to-
bacco products. No provision of this chapter shall 
limit or otherwise affect any State, Tribal, or local 
taxation of tobacco products. 
‘‘(2) PREEMPTION
OF
CERTAIN
STATE
AND 
LOCAL REQUIREMENTS.— 
‘‘(A) IN GENERAL.—No State or political 
subdivision of a State may establish or continue 
in effect with respect to a tobacco product any 
requirement which is different from, or in addi-
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HR 1108 RFS 
tion to, any requirement under the provisions of 
this chapter relating to tobacco product stand-
ards, premarket review, adulteration, mis-
branding, labeling, registration, good manufac-
turing standards, or modified risk tobacco prod-
ucts. 
‘‘(B) 
EXCEPTION.—Subparagraph 
(A) 
does not apply to requirements relating to the 
sale, distribution, possession, information re-
porting to the State, exposure to, access to, the 
advertising and promotion of, or use of, tobacco 
products by individuals of any age, or relating 
to fire safety standards for tobacco products. 
Information disclosed to a State under subpara-
graph (A) that is exempt from disclosure under 
section 552(b)(4) of title 5, United States Code, 
shall be treated as a trade secret and confiden-
tial information by the State. 
‘‘(b) RULE OF CONSTRUCTION REGARDING PRODUCT 
LIABILITY.—No provision of this chapter relating to a to-
bacco product shall be construed to modify or otherwise 
affect any action or the liability of any person under the 
product liability law of any State. 
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HR 1108 RFS 
‘‘SEC. 917. TOBACCO PRODUCTS SCIENTIFIC ADVISORY 
COMMITTEE. 
‘‘(a) ESTABLISHMENT.—Not later than 6 months 
after the date of enactment of the Family Smoking Pre-
vention and Tobacco Control Act, the Secretary shall es-
tablish a 12-member advisory committee, to be known as 
the Tobacco Products Scientific Advisory Committee (in 
this section referred to as the ‘Advisory Committee’). 
‘‘(b) MEMBERSHIP.— 
‘‘(1) IN GENERAL.— 
‘‘(A) MEMBERS.—The Secretary shall ap-
point as members of the Tobacco Products Sci-
entific Advisory Committee individuals who are 
technically qualified by training and experience 
in medicine, medical ethics, science, or tech-
nology involving the manufacture, evaluation, or 
use of tobacco products, who are of appro-
priately diversified professional backgrounds. 
The committee shall be composed of— 
‘‘(i) 7 individuals who are physicians, 
dentists, scientists, or health care profes-
sionals practicing in the area of oncology, 
pulmonology, cardiology, toxicology, phar-
macology, addiction, or any other relevant 
specialty; 
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HR 1108 RFS 
‘‘(ii) 1 individual who is an officer or 
employee of a State or local government or 
of the Federal Government; 
‘‘(iii) 1 individual as a representative 
of the general public; 
‘‘(iv) 1 individual as a representative 
of the interests of the tobacco manufac-
turing industry; 
‘‘(v) 1 individual as a representative 
of the interests of the small business to-
bacco manufacturing industry, which posi-
tion may be filled on a rotating, sequential 
basis by representatives of different small 
business tobacco manufacturers based on 
areas of expertise relevant to the topics 
being considered by the Advisory Com-
mittee; and 
‘‘(vi) 1 individual as a representative 
of the interests of the tobacco growers. 
‘‘(B) NONVOTING
MEMBERS.—The mem-
bers of the committee appointed under clauses 
(iv), (v), and (vi) of subparagraph (A) shall 
serve as consultants to those described in 
clauses (i) through (iii) of subparagraph (A) 
and shall be nonvoting representatives. 
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HR 1108 RFS 
‘‘(C) CONFLICTS OF INTEREST.—No mem-
bers of the committee, other than members ap-
pointed pursuant to clauses (iv), (v), and (vi) of 
subparagraph (A) shall, during the member’s 
tenure on the committee or for the 18-month 
period prior to becoming such a member, re-
ceive any salary, grants, or other payments or 
support from any business that manufactures, 
distributes, markets, or sells cigarettes or other 
tobacco products. 
‘‘(2) LIMITATION.—The Secretary may not ap-
point to the Advisory Committee any individual who 
is in the regular full-time employ of the Food and 
Drug Administration or any agency responsible for 
the enforcement of this Act. The Secretary may ap-
point Federal officials as ex officio members. 
‘‘(3) CHAIRPERSON.—The Secretary shall des-
ignate 1 of the members appointed under clauses (i), 
(ii), and (iii) of paragraph (1)(A) to serve as chair-
person. 
‘‘(c) DUTIES.—The Tobacco Products Scientific Ad-
visory Committee shall provide advice, information, and 
recommendations to the Secretary— 
‘‘(1) as provided in this chapter; 
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‘‘(2) on the effects of the alteration of the nico-
tine yields from tobacco products; 
‘‘(3) on whether there is a threshold level below 
which nicotine yields do not produce dependence on 
the tobacco product involved; and 
‘‘(4) on its review of other safety, dependence, 
or health issues relating to tobacco products as re-
quested by the Secretary. 
‘‘(d) COMPENSATION; SUPPORT; FACA.— 
‘‘(1) COMPENSATION AND TRAVEL.—Members 
of the Advisory Committee who are not officers or 
employees of the United States, while attending con-
ferences or meetings of the committee or otherwise 
engaged in its business, shall be entitled to receive 
compensation at rates to be fixed by the Secretary, 
which may not exceed the daily equivalent of the 
rate in effect under the Senior Executive Schedule 
under section 5382 of title 5, United States Code, 
for each day (including travel time) they are so en-
gaged; and while so serving away from their homes 
or regular places of business each member may be 
allowed travel expenses, including per diem in lieu of 
subsistence, as authorized by section 5703 of title 5, 
United States Code, for persons in the Government 
service employed intermittently. 
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HR 1108 RFS 
‘‘(2) ADMINISTRATIVE
SUPPORT.—The Sec-
retary shall furnish the Advisory Committee clerical 
and other assistance. 
‘‘(3) NONAPPLICATION OF FACA.—Section 14 of 
the Federal Advisory Committee Act does not apply 
to the Advisory Committee. 
‘‘(e) PROCEEDINGS OF ADVISORY PANELS AND COM-
MITTEES.—The Advisory Committee shall make and 
maintain a transcript of any proceeding of the panel or 
committee. Each such panel and committee shall delete 
from any transcript made under this subsection informa-
tion which is exempt from disclosure under section 552(b) 
of title 5, United States Code. 
‘‘SEC. 918. DRUG PRODUCTS USED TO TREAT TOBACCO DE-
PENDENCE. 
‘‘(a) IN GENERAL.—The Secretary shall— 
‘‘(1) at the request of the applicant, consider 
designating products for smoking cessation, includ-
ing nicotine replacement products as fast track re-
search and approval products within the meaning of 
section 506; 
‘‘(2) consider approving the extended use of nic-
otine replacement products (such as nicotine patch-
es, nicotine gum, and nicotine lozenges) for the 
treatment of tobacco dependence; and 
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HR 1108 RFS 
‘‘(3) review and consider the evidence for addi-
tional indications for nicotine replacement products, 
such as for craving relief or relapse prevention. 
‘‘(b) REPORT ON INNOVATIVE PRODUCTS.— 
‘‘(1) IN
GENERAL.—Not later than 3 years 
after the date of enactment of the Family Smoking 
Prevention and Tobacco Control Act, the Secretary, 
after consultation with recognized scientific, medical, 
and public health experts (including both Federal 
agencies and nongovernmental entities, the Institute 
of Medicine of the National Academy of Sciences, 
and the Society for Research on Nicotine and To-
bacco), shall submit to the Congress a report that 
examines how best to regulate, promote, and encour-
age the development of innovative products and 
treatments (including nicotine-based and non-nico-
tine-based products and treatments) to better 
achieve, in a manner that best protects and pro-
motes 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. 
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HR 1108 RFS 
‘‘(2) RECOMMENDATIONS.—The report under 
paragraph (1) shall include the recommendations of 
the Secretary on how the Food and Drug Adminis-
tration should coordinate and facilitate the exchange 
of information on such innovative products and 
treatments among relevant offices and centers within 
the Administration and within the National Insti-
tutes of Health, the Centers for Disease Control and 
Prevention, and other relevant agencies. 
‘‘SEC. 919. USER FEES. 
‘‘(a) ESTABLISHMENT OF QUARTERLY FEE.—Begin-
ning on the date of the 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 subject to this chapter. The fees shall 
be assessed and collected with respect to each quarter of 
each fiscal year, and the total amount assessed and col-
lected for a fiscal year shall be the amount specified in 
subsection (b)(1) for such year, subject to subsection (c). 
‘‘(b) ASSESSMENT OF USER 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: 
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HR 1108 RFS 
‘‘(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-
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HR 1108 RFS 
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 
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HR 1108 RFS 
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-
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HR 1108 RFS 
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-
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HR 1108 RFS 
bacco products subject to this section of the amount 
of the quarterly assessment imposed on such manu-
facturer or importer under this subsection for each 
quarter of each fiscal year. Such notifications shall 
occur not later than 30 days prior to the end of the 
quarter for which such assessment is made, and pay-
ments of all assessments shall be made by the last 
day of the quarter involved. 
‘‘(7) MEMORANDUM OF UNDERSTANDING.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
request the appropriate Federal agency to enter 
into a memorandum of understanding that pro-
vides for the regular and timely transfer from 
the head of such agency to the Secretary of the 
information described in paragraphs (2)(B)(ii) 
and (4) and all necessary information regarding 
all tobacco product manufacturers and import-
ers required to pay user fees. The Secretary 
shall maintain all disclosure restrictions estab-
lished by the head of such agency regarding the 
information provided under the memorandum of 
understanding. 
‘‘(B) ASSURANCES.—Beginning not later 
than fiscal year 2015, and for each subsequent 
fiscal year, the Secretary shall ensure that the 
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Food and Drug Administration is able to deter-
mine the applicable percentages described in 
paragraph (2) and the percentage shares de-
scribed in paragraph (4). The Secretary may 
carry out this subparagraph by entering into a 
contract with the head of the Federal agency 
referred to in subparagraph (A) to continue to 
provide the necessary information. 
‘‘(c) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN GENERAL.—Fees authorized under sub-
section (a) shall be collected and available for obliga-
tion only to the extent and in the amount provided 
in advance in appropriations Acts. Such fees are au-
thorized to remain available until expended. Such 
sums as may be necessary may be transferred from 
the Food and Drug Administration salaries and ex-
penses appropriation account without fiscal year lim-
itation to such appropriation account for salaries 
and expenses with such fiscal year limitation. 
‘‘(2) AVAILABILITY.— 
‘‘(A) IN
GENERAL.—Fees appropriated 
under paragraph (3) are available only for the 
purpose of paying the costs of the activities of 
the Food and Drug Administration related to 
the regulation of tobacco products under this 
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HR 1108 RFS 
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 
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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 the 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-
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