130 
‘‘(2) ADMINISTRATIVE SUPPORT.—The Secretary 
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 main-
tain a transcript of any proceeding of the panel or com-
mittee. Each such panel and committee shall delete from 
any transcript made under this subsection information 
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 des-
ignating products for smoking cessation, including 
nicotine replacement products as fast track research 
and approval products within the meaning of section 
506; 
‘‘(2) consider approving the extended use of nico-
tine replacement products (such as nicotine patches, 
nicotine gum, and nicotine lozenges) for the treatment 
of tobacco dependence; and 
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‘‘(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 Preven-
tion 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 Medi-
cine of the National Academy of Sciences, and the So-
ciety for Research on Nicotine and Tobacco), shall 
submit to the Congress a report that examines how 
best to regulate, promote, and encourage the develop-
ment of innovative products and treatments (includ-
ing 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) RECOMMENDATIONS.—The report under 
paragraph (1) shall include the recommendations of 
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the Secretary on how the Food and Drug Administra-
tion should coordinate and facilitate the exchange of 
information on such innovative products and treat-
ments among relevant offices and centers within the 
Administration and within the National Institutes of 
Health, the Centers for Disease Control and Preven-
tion, and other relevant agencies. 
‘‘SEC. 919. USER FEE. 
‘‘(a) ESTABLISHMENT OF QUARTERLY USER FEE.— 
The Secretary shall assess a quarterly user fee with respect 
to every quarter of each fiscal year commencing fiscal year 
2008, calculated in accordance with this section, upon each 
manufacturer and importer of tobacco products subject to 
this chapter. 
‘‘(b) FUNDING OF FDA REGULATION OF TOBACCO 
PRODUCTS.— 
‘‘(1) IN
GENERAL.—The Secretary shall make 
user fees collected pursuant to subsection (c)(1) avail-
able to pay, in each fiscal year beginning with fiscal 
year 2008, for the costs of the activities of the Food 
and Drug Administration related to the regulation of 
tobacco products under this chapter and the Family 
Smoking Prevention and Tobacco Control Act. No fees 
collected pursuant to subsection (c)(1) may be used by 
the Secretary for any other costs. 
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‘‘(2) AVAILABILITY.—Subject to paragraph (1), 
fees collected pursuant to subsection (c)(1) shall be 
available to the Secretary without further appropria-
tion in the following amounts: 
‘‘(A) For fiscal year 2008, $85,000,000. 
‘‘(B) For fiscal year 2009, $235,000,000. 
‘‘(C) For fiscal year 2010, $450,000,000. 
‘‘(D) For fiscal year 2011, $477,000,000. 
‘‘(E) For fiscal year 2012, $505,000,000. 
‘‘(F) For fiscal year 2013, $534,000,000. 
‘‘(G) For fiscal year 2014, $566,000,000. 
‘‘(H) For fiscal year 2015, $599,000,000. 
‘‘(I) For fiscal year 2016, $635,000,000. 
‘‘(J) For fiscal year 2017, $672,000,000. 
‘‘(K) For fiscal year 2018 and each subse-
quent fiscal year, $712,000,000. 
Fees made available to the Secretary under this para-
graph shall remain available until expended. 
‘‘(3) OFFSETTING RECEIPTS.—Fees collected pur-
suant to subsection (c)(1) shall be recorded as offset-
ting receipts. 
‘‘(4) PROHIBITION
AGAINST
USE
OF
OTHER 
FUNDS.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), fees collected pursuant to this 
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section shall be the only funds used to pay the 
costs of the activities of the Food and Drug Ad-
ministration related to the regulation of tobacco 
products under this chapter and the Family 
Smoking Prevention and Tobacco Control Act. 
‘‘(B) STARTUP COSTS.—Subparagraph (A) 
shall not apply until the date on which the Sec-
retary has collected fees pursuant to this section 
for 2 fiscal year quarters. Until such date, 
amounts available to the Food and Drug Admin-
istration (other than fees collected pursuant to 
this section) may be used to pay the costs de-
scribed in subparagraph (A), provided that such 
amounts are reimbursed through such fees. 
‘‘(c) ASSESSMENT OF USER FEE.— 
‘‘(1) AMOUNT OF ASSESSMENT.—The assessment 
under this section for— 
‘‘(A) fiscal year 2008 shall be $90,100,000; 
‘‘(B) fiscal year 2009 shall be $249,100,000; 
‘‘(C) fiscal year 2010 shall be $477,000,000; 
‘‘(D) fiscal year 2011 shall be $505,620,000; 
‘‘(E) fiscal year 2012 shall be $535,300,000; 
‘‘(F) fiscal year 2013 shall be $566,040,000; 
‘‘(G) fiscal year 2014 shall be $599,960,000; 
‘‘(H) fiscal year 2015 shall be $634,940,000; 
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‘‘(I) fiscal year 2016 shall be $673,100,000; 
‘‘(J) fiscal year 2017 shall be $712,320,000; 
and 
‘‘(K) fiscal year 2018 and each subsequent 
fiscal year shall be $754,720,000. 
‘‘(2) ALLOCATIONS OF ASSESSMENT BY CLASS OF 
TOBACCO PRODUCTS.— 
‘‘(A) IN GENERAL.—The total user fees as-
sessed 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 
multiplied by the amount specified in paragraph 
(1) for each fiscal year. 
‘‘(B) APPLICABLE PERCENTAGE.— 
‘‘(i) IN
GENERAL.—For purposes of 
subparagraph (A), the applicable percentage 
for a fiscal year for each of the following 
classes of tobacco products shall be deter-
mined 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. 
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‘‘(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 
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 Sec-
retary 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 products shall be re-
allocated to such other classes of tobacco 
products that are subject to this chapter in 
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the same manner and based on the same 
relative percentages otherwise determined 
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 par-
ticular class of tobacco products shall be deter-
mined in each quarter by multiplying— 
‘‘(i) such manufacturer’s or importer’s 
percentage share as determined under para-
graph (4); by 
‘‘(ii) the portion of the user fee amount 
for the current quarter to be assessed on all 
manufacturers and importers of such class 
of tobacco products as determined 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 manu-
facturer or importer. 
‘‘(4) ALLOCATION OF ASSESSMENT WITHIN EACH 
CLASS OF TOBACCO PRODUCT.—The percentage share 
of each manufacturer or importer of a particular 
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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 percentage 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 manu-
facturer or importer of cigars shall be based on the ex-
cise taxes paid by such manufacturer or importer 
during the prior fiscal year. 
‘‘(d) TIMING OF USER FEE ASSESSMENT.—The Sec-
retary shall notify each manufacturer and importer of to-
bacco products subject to this section of the amount of the 
quarterly assessment imposed on such manufacturer or im-
porter under subsection (c) during each quarter of each fis-
cal year. Such notifications shall occur not later than 30 
days prior to the end of the quarter for which such assess-
ment is made, and payments of all assessments shall be 
made by the last day of the quarter involved. 
‘‘(e) MEMORANDUM OF UNDERSTANDING.— 
‘‘(1) IN GENERAL.—The Secretary shall request 
the appropriate Federal agency to enter into a memo-
randum of understanding that provides for the reg-
ular and timely transfer from the head of such agency 
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to the Secretary of the information described in para-
graphs (2)(B)(ii) and (4) of subsection (c) and all 
necessary information regarding all tobacco product 
manufacturers and importers required to pay user 
fees. The Secretary shall maintain all disclosure re-
strictions established by the head of such agency re-
garding the information provided under the memo-
randum of understanding. 
‘‘(2) ASSURANCES.—Beginning not later than 
fiscal year 2015, and for each subsequent fiscal year, 
the Secretary shall ensure that the Food and Drug 
Administration is able to determine the applicable 
percentages described in subsection (c)(2) and the per-
centage shares described in subsection (c)(4). The Sec-
retary may carry out this paragraph by entering into 
a contract with the head of the Federal agency re-
ferred to in paragraph (1) to continue to provide the 
necessary information. 
‘‘(f) EFFECTIVE DATE.— 
‘‘(1) IN GENERAL.—The user fees prescribed by 
this section shall be assessed in fiscal year 2008, and 
shall be assessed in each fiscal year thereafter. 
‘‘(2) SPECIAL RULE.—If the date of enactment of 
the Family Smoking Prevention and Tobacco Control 
Act occurs during a quarter of fiscal year 2008, the 
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