preceding fiscal year divided by such index for Octo-
ber 2018. 
‘‘(2) COSMETIC FORMULATION.—The term ‘cos-
metic formulation’ has the meaning given to such 
term in section 604. 
‘‘(3) CONTRACT
MANUFACTURER.—The term 
‘contract manufacturer’ means a cosmetic manufac-
turer where neither the owner, operator, or agent in 
charge of such entity nor any affiliate of such owner, 
operator, or agent in charge sells the cosmetic ingre-
dient, cosmetic formulation, or cosmetic product un-
less there is a specific contractual agreement in 
place. 
‘‘(4) COSMETIC PRODUCT.—The term ‘cosmetic 
product’ has the meaning given to such term in sec-
tion 604. 
‘‘(5) COSMETIC SAFETY ACTIVITIES.—The term 
‘cosmetic safety activities’— 
‘‘(A) means activities of the Secretary re-
lated to compliance by responsible persons re-
quired to register under section 605 with re-
spect to cosmetics, including administrative ac-
tivities, such as— 
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‘‘(i) information technology acquisi-
tion, management, maintenance, and sup-
port; 
‘‘(ii) the acquisition, administration, 
and maintenance of the cosmetic registra-
tion system under section 605 and the cos-
metic ingredient statement system under 
section 606; 
‘‘(iii) fee assessment and collection 
under this part; and 
‘‘(iv) the acquisition, leasing, mainte-
nance, renovation, and repair of facilities, 
fixtures, furniture, scientific equipment, 
and other necessary materials and supplies 
for purposes of clauses (i) through (iii); 
‘‘(B) includes activities of the Secretary re-
lated to implementation of section 608, regard-
ing the review of cosmetic ingredients and non-
functional constituents; 
‘‘(C) includes activities of the Secretary re-
lated to implementation of section 606; 
‘‘(D) includes activities of the Secretary re-
lated to implementation and enforcement, such 
as the establishment of good manufacturing 
practices, the review of adverse event reports, 
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inspection planning and inspections, and use of 
enforcement tools; and 
‘‘(E) includes activities of the Secretary re-
lated to meetings with regulated industry re-
garding determinations under section 608. 
‘‘(6) GROSS ANNUAL SALES.—The term ‘gross 
annual sales’ means the average United States gross 
annual sales for the previous 3 fiscal years of cos-
metic products for a responsible person, including 
the sales of cosmetic products of all of its affiliates, 
as reported in the registration under section 605. 
‘‘(7) LARGE MANUFACTURER.—The term ‘large 
manufacturer’ means any entity that manufactures 
cosmetic products or cosmetic formulations for sale 
or distribution in the United States and has gross 
annual sales of over $500,000,000. 
‘‘(8) MIDSIZE
MANUFACTURER.—The term 
‘midsize manufacturer’ means any entity that manu-
factures cosmetic products or cosmetic formulations 
for sale or distribution in the United States and has 
gross annual sales that are not more than 
$500,000,000 and over $30,000,000. 
‘‘(9) SMALL MANUFACTURER.—The term ‘small 
manufacturer’ means any entity that manufactures 
cosmetic products or cosmetic formulations for sale 
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100 
or distribution in the United States and has gross 
annual sales that are not more than $30,000,000 
and over $1,000,000. 
‘‘(10) RESPONSIBLE
PERSON.—The term ‘re-
sponsible person’ means the owner, operator, agent 
in charge, or affiliate that owns the brand under 
which a cosmetic product is sold. 
‘‘SEC. 744M. REGISTRATION FEE. 
‘‘(a) ASSESSMENT AND COLLECTION.— 
‘‘(1) IN
GENERAL.—Beginning in fiscal year 
2020, the Secretary shall in accordance with this 
section assess and collect an annual fee from every 
responsible person that manufactures or distributes 
cosmetic products or cosmetic formulations in the 
United States. 
‘‘(2) PAYABLE DATE.—Fees under this section 
shall be due and payable— 
‘‘(A) for fiscal year 2020, with respect to 
responsible persons as described in paragraph 
(1) for such first program year, on the date 
that is 180 days after the identification in sub-
section (b); and 
‘‘(B) for fiscal year 2021 and each subse-
quent fiscal year, on the later of— 
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101 
‘‘(i) the date of registration or reg-
istration renewal, as applicable, under sec-
tion 605; or 
‘‘(ii) the date of enactment of an ap-
propriations Act providing for the collec-
tion and obligation of fees under this sec-
tion for the fiscal year involved. 
‘‘(b) ONE-TIME IDENTIFICATION OF RESPONSIBLE 
PERSONS FOR PURPOSES OF APPORTIONING FEES.— 
‘‘(1) REQUIRED IDENTIFICATION OF RESPON-
SIBLE PERSONS.—Not later than 120 days after en-
actment of the Cosmetic Safety Enhancement Act of 
2019, each responsible person that markets or sells 
a cosmetic product shall submit to the Secretary the 
information required under this subsection. 
‘‘(2) INFORMATION
REQUIRED
TO
BE
SUB-
MITTED.—At a minimum, the submission required 
by paragraph (1) shall include for each such respon-
sible person— 
‘‘(A) the gross annual sales of cosmetic 
products or cosmetic formulations for the pre-
vious 3 fiscal years as will be reported in the 
first registration under section 605 for such re-
sponsible person, and an assessment of whether 
such responsible person qualifies as a small, 
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midsize, or large manufacturer for the purposes 
of subsection (c)(3)(A); 
‘‘(B) identification of facilities where such 
responsible person’s cosmetic products or cos-
metic formulations are manufactured, which 
cosmetic products or cosmetic formulations are 
manufactured there, and any other products 
regulated under this Act that the facility manu-
factures; 
‘‘(C) the location of all such facilities iden-
tified in subparagraph (B); and 
‘‘(D) whether the facility is owned and op-
erated by a contract manufacturer. 
‘‘(3) NOTICE.—The Secretary may, by notice 
published in the Federal Register, specify the means 
and format for submission of the information under 
paragraph (2) and may specify, as necessary for 
purposes of this section, any additional information 
relevant to setting the annual fee under this section 
to be submitted. 
‘‘(c) FEE SETTING AND AMOUNTS.— 
‘‘(1) IN GENERAL.—Subject to subsection (d), 
the Secretary shall establish the fees to be collected 
under this section for each fiscal year beginning in 
fiscal year 2020, based on the methodology de-
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scribed in paragraph (3)(A), and shall publish such 
fees in each fiscal year after fiscal year 2020 in a 
Federal Register notice not later than 60 days be-
fore the beginning of each such fiscal year. For fis-
cal year 2020, the Secretary shall publish the fees 
150 days after the date of enactment of the Cos-
metic Safety Enhancement Act of 2019. 
‘‘(2) FEE EXEMPTION.—Any facility required to 
register under section 605 whose average gross an-
nual sales of cosmetic products in the 3 fiscal years 
immediately preceding the fiscal year for which the 
annual fee will be paid was not more than 
$1,000,000, shall be exempt from registration fees 
under this section for that fiscal year. 
‘‘(3) ANNUAL FEE SETTING.— 
‘‘(A) FEE
SETTING.—For fiscal years 
2020 to 2027, the amount of the registration 
fee under subsection (a) shall be apportioned as 
follows: 
‘‘(i) Seventy percent shall be derived 
from fees from large manufacturers. 
‘‘(ii) Twenty percent shall be derived 
from fees from midsize manufacturers. 
‘‘(iii) Ten percent shall be derived 
from fees from small manufacturers. 
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‘‘(B) TOTAL
REVENUE.—The Secretary 
shall establish the fee amounts for each fiscal 
year in accordance with subparagraph (A), in 
order to generate a total estimated revenue of— 
‘‘(i) $10,000,000 for fiscal year 2020; 
‘‘(ii) $20,000,000 for fiscal year 2021; 
‘‘(iii) $35,000,000 for fiscal year 
2022; and 
‘‘(iv) $46,000,000 for each of fiscal 
years 2023 through 2027. 
‘‘(d) ADJUSTMENTS.— 
‘‘(1) INFLATION ADJUSTMENTS.— 
‘‘(A) ADJUSTMENT
TO
TOTAL
REVENUE 
AMOUNTS.—For fiscal year 2020 and each sub-
sequent fiscal year, the Secretary shall adjust 
the total revenue amount specified in subsection 
(c)(3) for such fiscal year by multiplying such 
amount by the applicable inflation adjustment 
under subparagraph (B) for such year. 
‘‘(B) APPLICABLE
INFLATION
ADJUST-
MENT.—The applicable inflation adjustment for 
fiscal year 2022 and each subsequent fiscal 
year is the product of— 
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‘‘(i) the base inflation adjustment 
under subparagraph (C) for such fiscal 
year; and 
‘‘(ii) the product of the base inflation 
adjustment under subparagraph (C) for 
each of the fiscal years preceding such fis-
cal year, beginning with fiscal year 2020. 
‘‘(C) BASE INFLATION ADJUSTMENT.— 
‘‘(i) IN GENERAL.—Subject to further 
adjustment under clause (ii), the base in-
flation adjustment for a fiscal year is the 
sum of one plus— 
‘‘(I) the average annual percent 
change in the cost, per full-time equiv-
alent position of the Food and Drug 
Administration, of all personnel com-
pensation and benefits paid with re-
spect to such positions for the first 3 
fiscal years of the preceding 4 fiscal 
years, multiplied by 0.60; and 
‘‘(II) the average annual percent 
change that occurred in the Consumer 
Price Index for urban consumers 
(Washington-Arlington-Alexandria; 
Not Seasonally Adjusted; All items; 
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Annual Index) for the first 3 fiscal 
years of the preceding 4 years of 
available data multiplied by 0.40. 
‘‘(ii) LIMITATIONS.—For purposes of 
subparagraph (B), if the base inflation ad-
justment for a fiscal year under clause 
(i)— 
‘‘(I) is less than 1, such adjust-
ment shall be considered to be equal 
to 1; or 
‘‘(II) is greater than 1.04, such 
adjustment shall be considered to be 
equal to 1.04. 
‘‘(2) FINAL
YEAR
ADJUSTMENT.—For fiscal 
year 2027, the Secretary may, in addition to adjust-
ments under paragraph (1), further increase the fee 
revenues and fees established in subsection (c) if 
such an adjustment is necessary to provide for not 
more than 3 months of operating reserves of carry-
over fees for cosmetic safety activities for the first 
3 months of fiscal year 2028. If such an adjustment 
is necessary, the rationale for the increase shall be 
contained in the annual Federal Register notice es-
tablishing fees for fiscal year 2027. If the Food and 
Drug Administration has carryover balances for 
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such activities in excess of 3 months of such oper-
ating reserves, the adjustment under this paragraph 
shall not be made. 
‘‘(e) LIMITATIONS.— 
‘‘(1) IN GENERAL.—With respect to the amount 
that is appropriated for a fiscal year for the cos-
metics program of the Center for Food Safety and 
Applied Nutrition of the Food and Drug Administra-
tion and related field activities, fees may not be as-
sessed under subsection (a) for the fiscal year unless 
the amount so appropriated (excluding the amount 
of fees appropriated for the fiscal year), is equal to 
or greater than the amount that is appropriated for 
such program for fiscal year 2019, multiplied by the 
adjustment factor applicable to the fiscal year in-
volved. If the amount so appropriated prevents the 
Secretary from assessing fees under subsection (a), 
the Secretary is not required to carry out any activi-
ties described in section 608 during that fiscal year. 
‘‘(2) AUTHORITY.—If the Secretary does not 
assess fees under subsection (a) during any portion 
of a fiscal year because of paragraph (1) and if at 
a later date in such fiscal year the Secretary may as-
sess such fees, the Secretary may assess and collect 
such fees, without any modification in the rate, for 
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registration under section 605 at any time in such 
fiscal year. 
‘‘(f) 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. The 
sums transferred shall be available solely for cos-
metic safety activities. 
‘‘(2) 
COLLECTIONS
AND
APPROPRIATIONS 
ACTS.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graphs (C) and (D), the fees authorized by this 
section shall be collected and available in each 
fiscal year in an amount not to exceed the 
amount specified in appropriation Acts, or oth-
erwise made available for obligation, for such 
fiscal year. 
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