109 
‘‘(i) the first business day on or after 
October 1 of each such year; or 
‘‘(ii) the first business day after the 
enactment of an appropriations Act pro-
viding for the collection and obligation of 
fees for such year under this section. 
‘‘(C) ONE FEE PER PRODUCT PER YEAR.— 
The biosimilar biological product fee shall be 
paid only once for each product for each fiscal 
year. 
‘‘(b) FEE SETTING AND AMOUNTS.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), 
the Secretary shall, 60 days before the start of each 
fiscal year that begins after September 30, 2012, es-
tablish, for the next fiscal year, the fees under sub-
section (a). Except as provided in subsection (c), 
such fees shall be in the following amounts: 
‘‘(A) 
INITIAL
BIOSIMILAR
BIOLOGICAL 
PRODUCT DEVELOPMENT FEE.—The initial bio-
similar biological product development fee under 
subsection (a)(1)(A) for a fiscal year shall be 
equal to 10 percent of the amount established 
under section 736(c)(4) for a human drug ap-
plication described in section 736(a)(1)(A)(i) 
for that fiscal year. 
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110 
‘‘(B) ANNUAL
BIOSIMILAR
BIOLOGICAL 
PRODUCT
DEVELOPMENT
FEE.—The annual 
biosimilar biological product development fee 
under subsection (a)(1)(B) for a fiscal year 
shall be equal to 10 percent of the amount es-
tablished under section 736(c)(4) for a human 
drug 
application 
described 
in 
section 
736(a)(1)(A)(i) for that fiscal year. 
‘‘(C) REACTIVATION
FEE.—The reactiva-
tion fee under subsection (a)(1)(D) for a fiscal 
year shall be equal to 20 percent of the amount 
of the fee established under section 736(c)(4) 
for a human drug application described in sec-
tion 736(a)(1)(A)(i) for that fiscal year. 
‘‘(D) BIOSIMILAR
BIOLOGICAL
PRODUCT 
APPLICATION
FEE.—The biosimilar biological 
product application fee under subsection (a)(2) 
for a fiscal year shall be equal to the amount 
established under section 736(c)(4) for a 
human drug application described in section 
736(a)(1)(A)(i) for that fiscal year. 
‘‘(E) BIOSIMILAR
BIOLOGICAL
PRODUCT 
ESTABLISHMENT FEE.—The biosimilar biologi-
cal product establishment fee under subsection 
(a)(3) for a fiscal year shall be equal to the 
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111 
amount established under section 736(c)(4) for 
a prescription drug establishment for that fiscal 
year. 
‘‘(F) BIOSIMILAR
BIOLOGICAL
PRODUCT 
FEE.—The biosimilar biological product fee 
under subsection (a)(4) for a fiscal year shall be 
equal to the amount established under section 
736(c)(4) for a prescription drug product for 
that fiscal year. 
‘‘(2) LIMIT.—The total amount of fees charged 
for a fiscal year under this section may not exceed 
the total amount for such fiscal year of the costs of 
resources allocated for the process for the review of 
biosimilar biological product applications. 
‘‘(c) APPLICATION FEE WAIVER FOR SMALL BUSI-
NESS.— 
‘‘(1) WAIVER OF APPLICATION FEE.—The Sec-
retary shall grant to a person who is named in a bio-
similar biological product application a waiver from 
the application fee assessed to that person under 
subsection (a)(2)(A) for the first biosimilar biologi-
cal product application that a small business or its 
affiliate submits to the Secretary for review. After a 
small business or its affiliate is granted such a waiv-
er, the small business or its affiliate shall pay— 
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‘‘(A) application fees for all subsequent 
biosimilar biological product applications sub-
mitted to the Secretary for review in the same 
manner as an entity that is not a small busi-
ness; and 
‘‘(B) all supplement fees for all supple-
ments to biosimilar biological product applica-
tions submitted to the Secretary for review in 
the same manner as an entity that is not a 
small business. 
‘‘(2) CONSIDERATIONS.—In determining wheth-
er to grant a waiver of a fee under paragraph (1), 
the Secretary shall consider only the circumstances 
and assets of the applicant involved and any affiliate 
of the applicant. 
‘‘(3) SMALL BUSINESS DEFINED.—In this sub-
section, the term ‘small business’ means an entity 
that has fewer than 500 employees, including em-
ployees of affiliates, and does not have a drug prod-
uct that has been approved under a human drug ap-
plication (as defined in section 735) or a biosimilar 
biological product application (as defined in section 
744G(4)) and introduced or delivered for introduc-
tion into interstate commerce. 
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113 
‘‘(d) EFFECT OF FAILURE TO PAY FEES.—A bio-
similar biological product application or supplement sub-
mitted by a person subject to fees under subsection (a) 
shall be considered incomplete and shall not be accepted 
for filing by the Secretary until all fees owed by such per-
son have been paid. 
‘‘(e) CREDITING AND AVAILABILITY OF FEES.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), 
fees authorized under subsection (a) shall be col-
lected and available for obligation only to the extent 
and in the amount provided in advance in appropria-
tions Acts. Such fees are authorized to remain avail-
able until expended. Such sums as may be necessary 
may be transferred from the Food and Drug Admin-
istration salaries and expenses appropriation account 
without fiscal year limitation to such appropriation 
account for salaries and expenses with such fiscal 
year limitation. The sums transferred shall be avail-
able solely for the process for the review of bio-
similar biological product applications. 
‘‘(2) 
COLLECTIONS
AND
APPROPRIATION 
ACTS.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graphs (C) and (D), the fees authorized by this 
section shall be collected and available in each 
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114 
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. 
‘‘(B) USE
OF
FEES
AND
LIMITATION.— 
The fees authorized by this section shall be 
available for a fiscal year beginning after fiscal 
year 2012 to defray the costs of the process for 
the review of biosimilar biological product appli-
cations (including such costs for an additional 
number of full-time equivalent positions in the 
Department of Health and Human Services to 
be engaged in such process), only if the Sec-
retary allocates for such purpose an amount for 
such fiscal year (excluding amounts from fees 
collected under this section) no less than 
$20,000,000, multiplied by the adjustment fac-
tor applicable to the fiscal year involved. 
‘‘(C) FEE
COLLECTION
DURING
FIRST 
PROGRAM YEAR.—Until the date of enactment 
of an Act making appropriations through Sep-
tember 30, 2013, for the salaries and expenses 
account of the Food and Drug Administration, 
fees authorized by this section for fiscal year 
2013 may be collected and shall be credited to 
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115 
such account and remain available until ex-
pended. 
‘‘(D) PROVISION FOR EARLY PAYMENTS IN 
SUBSEQUENT YEARS.—Payment of fees author-
ized under this section for a fiscal year (after 
fiscal year 2013), prior to the due date for such 
fees, may be accepted by the Secretary in ac-
cordance with authority provided in advance in 
a prior year appropriations Act. 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
For each of fiscal years 2013 through 2017, there 
is authorized to be appropriated for fees under this 
section an amount equivalent to the total amount of 
fees assessed for such fiscal year under this section. 
‘‘(f) 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. 
‘‘(g) WRITTEN REQUESTS FOR WAIVERS AND RE-
FUNDS.—To qualify for consideration for a waiver under 
subsection (c), or for a refund of any fee collected in ac-
cordance with subsection (a)(2)(A), a person shall submit 
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116 
to the Secretary a written request for such waiver or re-
fund not later than 180 days after such fee is due. 
‘‘(h) CONSTRUCTION.—This section may not be con-
strued to require that the number of full-time equivalent 
positions in the Department of Health and Human Serv-
ices, for officers, employers, and advisory committees not 
engaged in the process of the review of biosimilar biologi-
cal product applications, be reduced to offset the number 
of officers, employees, and advisory committees so en-
gaged.’’. 
SEC. 403. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Part 8 of subchapter C of chapter VII, as added by 
section 402 of this Act, is further amended by inserting 
after section 744H the following: 
‘‘SEC. 
744I. 
REAUTHORIZATION; 
REPORTING 
REQUIRE-
MENTS. 
‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal 
year 2013, not later than 120 days after the end of each 
fiscal year for which fees are collected under this part, 
the Secretary shall prepare and submit to the Committee 
on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report concerning the progress 
of the Food and Drug Administration in achieving the 
goals identified in the letters described in section 401(b) 
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of the Biosimilar User Fee Act of 2012 during such fiscal 
year and the future plans of the Food and Drug Adminis-
tration for meeting such goals. The report for a fiscal year 
shall include information on all previous cohorts for which 
the Secretary has not given a complete response on all 
biosimilar biological product applications and supplements 
in the cohort. 
‘‘(b) FISCAL REPORT.—Not later than 120 days after 
the end of fiscal year 2013 and each subsequent fiscal year 
for which fees are collected under this part, the Secretary 
shall prepare and submit to the Committee on Energy and 
Commerce of the House of Representatives and the Com-
mittee on Health, Education, Labor, and Pensions of the 
Senate a report on the implementation of the authority 
for such fees during such fiscal year and the use, by the 
Food and Drug Administration, of the fees collected for 
such fiscal year. 
‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall 
make the reports required under subsections (a) and (b) 
available to the public on the Internet Web site of the 
Food and Drug Administration. 
‘‘(d) STUDY.— 
‘‘(1) IN GENERAL.—The Secretary shall con-
tract with an independent accounting or consulting 
firm to study the workload volume and full costs as-
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118 
sociated with the process for the review of biosimilar 
biological product applications. 
‘‘(2) INTERIM RESULTS.—Not later than June 
1, 2015, the Secretary shall publish, for public com-
ment, interim results of the study described under 
paragraph (1). 
‘‘(3) FINAL
RESULTS.—Not later than Sep-
tember 30, 2016, the Secretary shall publish, for 
public comment, the final results of the study de-
scribed under paragraph (1). 
‘‘(e) REAUTHORIZATION.— 
‘‘(1) 
CONSULTATION.—In 
developing 
rec-
ommendations to present to the Congress with re-
spect to the goals described in subsection (a), and 
plans for meeting the goals, for the process for the 
review of biosimilar biological product applications 
for the first 5 fiscal years after fiscal year 2017, and 
for the reauthorization of this part for such fiscal 
years, the Secretary shall consult with— 
‘‘(A) the Committee on Energy and Com-
merce of the House of Representatives; 
‘‘(B) the Committee on Health, Education, 
Labor, and Pensions of the Senate; 
‘‘(C) scientific and academic experts; 
‘‘(D) health care professionals; 
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graph, and any changes made to the recommenda-
tions in response to such views and comments.’’. 
SEC. 404. SUNSET DATES. 
(a) AUTHORIZATION.—Sections 744G and 744H, as 
added by section 402 of this Act, are repealed October 
1, 2017. 
(b) REPORTING REQUIREMENTS.—Section 744I, as 
added by section 403 of this Act, is repealed January 31, 
2018. 
SEC. 405. EFFECTIVE DATE. 
(a) IN GENERAL.—Except as provided under sub-
section (b), the amendments made by this title shall take 
effect on the later of— 
(1) October 1, 2012; or 
(2) the date of the enactment of this title. 
(b) EXCEPTION.—Fees under part 8 of subchapter 
C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, as added by this title, shall be assessed for all bio-
similar biological product applications received on or after 
October 1, 2012, regardless of the date of the enactment 
of this title. 
SEC. 406. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this title, 
part 2 of subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act, as in effect on the day before 
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