‘‘(i) if no investigational new drug ap-
plication concerning the product has been 
submitted, submitting to the Secretary a 
written declaration that the person has no 
present intention of further developing the 
product as a biosimilar biological product; 
or 
‘‘(ii) if an investigational new drug 
application concerning the product has 
been submitted, by withdrawing the inves-
tigational new drug application in accord-
ance with part 312 of title 21, Code of 
Federal Regulations (or any successor reg-
ulations). 
‘‘(D) REACTIVATION FEE.— 
‘‘(i) IN GENERAL.—A person that has 
discontinued participation in the biosimilar 
biological product development program for 
a product under subparagraph (C) shall 
pay a fee (referred to in this section as ‘re-
activation fee’) by the earlier of the fol-
lowing: 
‘‘(I) Not later than 5 days after 
the Secretary grants a request for a 
biosimilar biological product develop-
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ment meeting for the product (after 
the date on which such participation 
was discontinued). 
‘‘(II) Upon the date of submis-
sion (after the date on which such 
participation was discontinued) of an 
investigational new drug application 
describing an investigation that the 
Secretary determines is intended to 
support a biosimilar biological product 
application for that product. 
‘‘(ii) 
APPLICATION
OF
ANNUAL 
FEE.—A person that pays a reactivation 
fee for a product shall pay for such prod-
uct, beginning in the next fiscal year, the 
annual biosimilar biological product devel-
opment fee under subparagraph (B). 
‘‘(E) EFFECT OF FAILURE TO PAY BIO-
SIMILAR DEVELOPMENT PROGRAM FEES.— 
‘‘(i) 
NO
BIOSIMILAR
BIOLOGICAL 
PRODUCT DEVELOPMENT MEETINGS.—If a 
person has failed to pay an initial or an-
nual biosimilar biological product develop-
ment fee as required under subparagraph 
(A) or (B), or a reactivation fee as re-
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quired under subparagraph (D), the Sec-
retary shall not provide a biosimilar bio-
logical product development meeting relat-
ing to the product for which fees are owed. 
‘‘(ii) NO
RECEIPT
OF
INVESTIGA-
TIONAL
NEW
DRUG
APPLICATIONS.—Ex-
cept in extraordinary circumstances, the 
Secretary shall not consider an investiga-
tional new drug application to have been 
received under section 505(i)(2) if— 
‘‘(I) the Secretary determines 
that the investigation is intended to 
support a biosimilar biological product 
application; and 
‘‘(II) the sponsor has failed to 
pay an initial or annual biosimilar bio-
logical product development fee for 
the product as required under sub-
paragraph (A) or (B), or a reactiva-
tion fee as required under subpara-
graph (D). 
‘‘(iii) 
FINANCIAL
HOLD.—Notwith-
standing section 505(i)(2), except in ex-
traordinary circumstances, the Secretary 
shall prohibit the sponsor of a clinical in-
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vestigation from continuing the investiga-
tion if— 
‘‘(I) the Secretary determines 
that the investigation is intended to 
support a biosimilar biological product 
application; and 
‘‘(II) the sponsor has failed to 
pay an initial or annual biosimilar bio-
logical product development fee for 
the product as required under sub-
paragraph (A) or (B), or a reactiva-
tion fee for the product as required 
under subparagraph (D). 
‘‘(iv) NO ACCEPTANCE OF BIOSIMILAR 
BIOLOGICAL
PRODUCT
APPLICATIONS
OR 
SUPPLEMENTS.—If a person has failed to 
pay an initial or annual biosimilar biologi-
cal product development fee as required 
under subparagraph (A) or (B), or a reac-
tivation fee as required under subpara-
graph (D), any biosimilar biological prod-
uct application or supplement submitted by 
that person shall be considered incomplete 
and shall not be accepted for filing by the 
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Secretary until all such fees owed by such 
person have been paid. 
‘‘(F) LIMITS REGARDING BIOSIMILAR DE-
VELOPMENT PROGRAM FEES.— 
‘‘(i) NO
REFUNDS.—The Secretary 
shall not refund any initial or annual bio-
similar biological product development fee 
paid under subparagraph (A) or (B), or 
any reactivation fee paid under subpara-
graph (D). 
‘‘(ii) NO WAIVERS, EXEMPTIONS, OR 
REDUCTIONS.—The Secretary shall not 
grant a waiver, exemption, or reduction of 
any initial or annual biosimilar biological 
product development fee due or payable 
under subparagraph (A) or (B), or any re-
activation fee due or payable under sub-
paragraph (D). 
‘‘(2) BIOSIMILAR BIOLOGICAL PRODUCT APPLI-
CATION AND SUPPLEMENT FEE.— 
‘‘(A) IN GENERAL.—Each person that sub-
mits, on or after October 1, 2012, a biosimilar 
biological product application or a supplement 
shall be subject to the following fees: 
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‘‘(i) A fee for a biosimilar biological 
product application that is equal to— 
‘‘(I) the amount of the fee estab-
lished under subsection (b)(1)(D) for 
a biosimilar biological product applica-
tion; minus 
‘‘(II) the cumulative amount of 
fees paid, if any, under subparagraphs 
(A), (B), and (D) of paragraph (1) 
for the product that is the subject of 
the application. 
‘‘(ii) A fee for a biosimilar biological 
product application for which clinical data 
(other than comparative bioavailability 
studies) with respect to safety or effective-
ness are not required, that is equal to— 
‘‘(I) half of the amount of the fee 
established under subsection (b)(1)(D) 
for a biosimilar biological product ap-
plication; minus 
‘‘(II) the cumulative amount of 
fees paid, if any, under subparagraphs 
(A), (B), and (D) of paragraph (1) 
for that product. 
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‘‘(iii) A fee for a supplement for which 
clinical data (other than comparative bio-
availability studies) with respect to safety 
or effectiveness are required, that is equal 
to half of the amount of the fee established 
under subsection (b)(1)(D) for a biosimilar 
biological product application. 
‘‘(B) 
REDUCTION
IN
FEES.—Notwith-
standing section 204 of the Biosimilars User 
Fee Act of 2012, any person who pays a fee 
under subparagraph (A), (B), or (D) of para-
graph (1) for a product before October 1, 2017, 
but submits a biosimilar biological product ap-
plication for that product after such date, shall 
be entitled to the reduction of any biosimilar bi-
ological product application fees that may be 
assessed at the time when such biosimilar bio-
logical product application is submitted, by the 
cumulative amount of fees paid under subpara-
graphs (A), (B), and (D) of paragraph (1) for 
that product. 
‘‘(C) PAYMENT DUE DATE.—Any fee re-
quired by subparagraph (A) shall be due upon 
submission of the application or supplement for 
which such fee applies. 
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‘‘(D) EXCEPTION FOR PREVIOUSLY FILED 
APPLICATION OR SUPPLEMENT.—If a biosimilar 
biological product application or supplement 
was submitted by a person that paid the fee for 
such application or supplement, was accepted 
for filing, and was not approved or was with-
drawn (without a waiver), the submission of a 
biosimilar biological product application or a 
supplement for the same product by the same 
person (or the person’s licensee, assignee, or 
successor) shall not be subject to a fee under 
subparagraph (A). 
‘‘(E) REFUND OF APPLICATION FEE IF AP-
PLICATION
REFUSED
FOR
FILING
OR
WITH-
DRAWN BEFORE FILING.—The Secretary shall 
refund 75 percent of the fee paid under this 
paragraph for any application or supplement 
which is refused for filing or withdrawn without 
a waiver before filing. 
‘‘(F) 
FEES
FOR
APPLICATIONS
PRE-
VIOUSLY REFUSED FOR FILING OR WITHDRAWN 
BEFORE FILING.—A biosimilar biological prod-
uct application or supplement that was sub-
mitted but was refused for filing, or was with-
drawn before being accepted or refused for fil-
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ing, shall be subject to the full fee under sub-
paragraph (A) upon being resubmitted or filed 
over protest, unless the fee is waived under sub-
section (c). 
‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT ESTAB-
LISHMENT FEE.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (E)(ii), each person that is 
named as the applicant in a biosimilar biologi-
cal product application shall be assessed an an-
nual fee established under subsection (b)(1)(E) 
for each biosimilar biological product establish-
ment that is listed in the approved biosimilar 
biological product application as an establish-
ment that manufactures the biosimilar biologi-
cal product named in such application. 
‘‘(B) ASSESSMENT IN FISCAL YEARS.—The 
establishment fee shall be assessed in each fis-
cal year for which the biosimilar biological prod-
uct named in the application is assessed a fee 
under paragraph (4) unless the biosimilar bio-
logical product establishment listed in the appli-
cation does not engage in the manufacture of 
the biosimilar biological product during such 
fiscal year. 
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‘‘(C) DUE DATE.—The establishment fee 
for a fiscal year shall be due on the later of— 
‘‘(i) the first business day on or after 
October 1 of such fiscal 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 fiscal year under this section. 
‘‘(D) APPLICATION TO ESTABLISHMENT.— 
‘‘(i) Each biosimilar biological product 
establishment shall be assessed only one 
fee per biosimilar biological product estab-
lishment, notwithstanding the number of 
biosimilar biological products manufac-
tured at the establishment, subject to 
clause (ii). 
‘‘(ii) In the event an establishment is 
listed in a biosimilar biological product ap-
plication by more than one applicant, the 
establishment fee for the fiscal year shall 
be divided equally and assessed among the 
applicants whose biosimilar biological prod-
ucts are manufactured by the establish-
ment during the fiscal year and assessed 
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biosimilar biological product fees under 
paragraph (4). 
‘‘(E) EXCEPTION FOR NEW PRODUCTS.— 
If, during the fiscal year, an applicant initiates 
or causes to be initiated the manufacture of a 
biosimilar biological product at an establish-
ment listed in its biosimilar biological product 
application— 
‘‘(i) that did not manufacture the bio-
similar biological product in the previous 
fiscal year; and 
‘‘(ii) for which the full biosimilar bio-
logical product establishment fee has been 
assessed in the fiscal year at a time before 
manufacture of the biosimilar biological 
product was begun, 
the applicant shall not be assessed a share of 
the biosimilar biological product establishment 
fee for the fiscal year in which the manufacture 
of the product began. 
‘‘(4) BIOSIMILAR BIOLOGICAL PRODUCT FEE.— 
‘‘(A) IN GENERAL.—Each person who is 
named as the applicant in a biosimilar biologi-
cal product application shall pay for each such 
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biosimilar biological product the annual fee es-
tablished under subsection (b)(1)(F). 
‘‘(B) DUE DATE.—The biosimilar biologi-
cal product fee for a fiscal year shall be due on 
the later of— 
‘‘(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 
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subsection (a)(1)(A) for a fiscal year shall be 
equal to 10 percent of the amount established 
under section 736(c)(5) for a human drug ap-
plication described in section 736(a)(1)(A)(i) 
for that fiscal year. 
‘‘(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)(5) 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)(5) 
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)(5) for a 
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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— 
‘‘(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-
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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. 
‘‘(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. 
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‘‘(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 
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 
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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 
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. 
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‘‘(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 
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. 203. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Part 8 of subchapter C of chapter VII, as amended 
by section 202 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 
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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 201(c) 
of the Biosimilars 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. 
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‘‘(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-
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; 
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‘‘(B) the Committee on Health, Education, 
Labor, and Pensions of the Senate; 
‘‘(C) scientific and academic experts; 
‘‘(D) health care professionals; 
‘‘(E) representatives of patient and con-
sumer advocacy groups; and 
‘‘(F) the regulated industry. 
‘‘(2) 
PUBLIC
REVIEW
OF
RECOMMENDA-
TIONS.—After negotiations with the regulated indus-
try, the Secretary shall— 
‘‘(A) present the recommendations devel-
oped under paragraph (1) to the Congressional 
committees specified in such paragraph; 
‘‘(B) publish such recommendations in the 
Federal Register; 
‘‘(C) provide for a period of 30 days for 
the public to provide written comments on such 
recommendations; 
‘‘(D) hold a meeting at which the public 
may present its views on such recommenda-
tions; and 
‘‘(E) after consideration of such public 
views and comments, revise such recommenda-
tions as necessary. 
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‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.— 
Not later than January 15, 2017, the Secretary 
shall transmit to the Congress the revised rec-
ommendations under paragraph (2), a summary of 
the views and comments received under such para-
graph, and any changes made to the recommenda-
tions in response to such views and comments.’’. 
SEC. 204. SUNSET DATES. 
(a) AUTHORIZATION.—The amendment made by sec-
tion 202 shall cease to be effective October 1, 2017. 
(b) REPORTING REQUIREMENTS.—The amendment 
made by section 203 shall cease to be effective January 
31, 2018. 
SEC. 205. 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 7 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. 
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SEC. 206. SAVINGS CLAUSE. 
Notwithstanding section 106 of the Prescription 
Drug User Fee Amendments of 2007 (21 U.S.C. 379g 
note), and 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 the date of the enactment of this title, shall con-
tinue to be in effect with respect to human drug applica-
tions and supplements (as defined in such part as of such 
day) that were accepted by the Food and Drug Adminis-
tration for filing on or after October 1, 2007, but before 
October 1, 2012, with respect to assessing and collecting 
any fee required by such part for a fiscal year prior to 
fiscal year 2013. 
SEC. 207. TECHNICAL AMENDMENT; CONFORMING AMEND-
MENT. 
Section 735(1)(B) (21 U.S.C. 379g(1)(B)) is amend-
ed by striking ‘‘or (k)’’. 
Æ 
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