such that no new abbreviated new drug ap-
plication or supplement submitted on or 
after October 1, 2012, from the person 
that is responsible for paying such fee, or 
any affiliate of that person, will be received 
within the meaning of section 505(j)(5)(A). 
‘‘(ii) Any new generic drug submission 
submitted on or after October 1, 2012, 
that references such a facility shall not be 
received, within the meaning of section 
505(j)(5)(A) if the outstanding facility fee 
is not paid within 20 calendar days of the 
Secretary providing the notification to the 
sponsor of the failure of the owner of the 
facility to pay the facility fee under sub-
section (a)(4)(C). 
‘‘(iii) All drugs or active pharma-
ceutical ingredients manufactured in such 
a facility or containing an ingredient man-
ufactured in such a facility shall be deemed 
misbranded under section 502(aa). 
‘‘(B) APPLICATION
OF
PENALTIES.—The 
penalties under this paragraph shall apply until 
the fee established by subsection (a)(4) is paid 
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or the facility is removed from all generic drug 
submissions that refer to the facility. 
‘‘(C) NONRECEIVAL FOR NONPAYMENT.— 
‘‘(i) NOTICE.—If an abbreviated new 
drug application or supplement to an ab-
breviated new drug application submitted 
on or after October 1, 2012, references a 
facility for which a facility fee has not been 
paid by the applicable date under sub-
section (a)(4)(C), the Secretary shall notify 
the sponsor of the generic drug submission 
of the failure of the owner of the facility 
to pay the facility fee. 
‘‘(ii) NONRECEIVAL.—If the facility 
fee is not paid within 20 calendar days of 
the Secretary providing the notification 
under clause (i), the abbreviated new drug 
application or supplement to an abbre-
viated new drug application shall not be re-
ceived within the meaning of section 
505(j)(5)(A). 
‘‘(h) LIMITATIONS.— 
‘‘(1) IN GENERAL.—Fees under subsection (a) 
shall be refunded for a fiscal year beginning after 
fiscal year 2012, unless appropriations for salaries 
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and expenses of the Food and Drug Administration 
for such fiscal year (excluding the amount of fees 
appropriated for such fiscal year) are equal to or 
greater than the amount of appropriations for the 
salaries and expenses of the Food and Drug Admin-
istration for the fiscal year 2009 (excluding the 
amount of fees appropriated for such fiscal year) 
multiplied by the adjustment factor (as defined in 
section 744A) applicable to the fiscal year involved. 
‘‘(2) AUTHORITY.—If the Secretary does not 
assess fees under subsection (a) during any portion 
of a fiscal year and if at a later date in such fiscal 
year the Secretary may assess such fees, the Sec-
retary may assess and collect such fees, without any 
modification in the rate, for Type II active pharma-
ceutical ingredient drug master files, abbreviated 
new drug applications and prior approval supple-
ments, and generic drug facilities and active phar-
maceutical ingredient facilities at any time in such 
fiscal year notwithstanding the provisions of sub-
section (a) relating to the date fees are to be paid. 
‘‘(i) 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 
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in advance in appropriations Acts, subject to para-
graph (2). 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 human generic drug activities. 
‘‘(2) 
COLLECTIONS
AND
APPROPRIATION 
ACTS.— 
‘‘(A) IN
GENERAL.—The fees authorized 
by this section— 
‘‘(i) subject to subparagraphs (C) and 
(D), shall be collected and available in each 
fiscal year in an amount not to exceed the 
amount specified in appropriation Acts, or 
otherwise made available for obligation for 
such fiscal year; and 
‘‘(ii) shall be available for a fiscal year 
beginning after fiscal year 2012 to defray 
the costs of human generic drug activities 
(including such costs for an additional 
number of full-time equivalent positions in 
the Department of Health and Human 
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Services to be engaged in such activities), 
only if the Secretary allocates for such 
purpose an amount for such fiscal year 
(excluding amounts from fees collected 
under 
this 
section) 
no 
less 
than 
$97,000,000 multiplied by the adjustment 
factor defined in section 744A(3) applica-
ble to the fiscal year involved. 
‘‘(B) COMPLIANCE.—The Secretary shall 
be considered to have met the requirements of 
subparagraph (A)(ii) in any fiscal year if the 
costs funded by appropriations and allocated for 
human generic activities are not more than 10 
percent below the level specified in such sub-
paragraph. 
‘‘(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 
such account and remain available until ex-
pended. 
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‘‘(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 the fiscal years 2013 through 2017, 
there is authorized to be appropriated for fees under 
this section an amount equivalent to the total rev-
enue amount determined under subsection (b) for 
the fiscal year, as adjusted under subsection (c), if 
applicable, or as otherwise affected under paragraph 
(2) of this subsection. 
‘‘(j) COLLECTION OF UNPAID FEES.—In any case 
where the Secretary does not receive payment of a fee as-
sessed under subsection (a) within 30 calendar 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. 
‘‘(k) 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, employees, and advisory committees not 
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engaged in human generic drug activities, be reduced to 
offset the number of officers, employees, and advisory 
committees so engaged. 
‘‘(l) POSITRON EMISSION TOMOGRAPHY DRUGS.— 
‘‘(1) EXEMPTION FROM FEES.—Submission of 
an application for a positron emission tomography 
drug or active pharmaceutical ingredient for a 
positron emission tomography drug shall not require 
the payment of any fee under this section. Facilities 
that solely produce positron emission tomography 
drugs shall not be required to pay a facility fee as 
established in subsection (a)(4). 
‘‘(2) IDENTIFICATION
REQUIREMENT.—Facili-
ties that produce positron emission tomography 
drugs or active pharmaceutical ingredients of such 
drugs are required to be identified pursuant to sub-
section (f). 
‘‘(m) DISPUTES CONCERNING FEES.—To qualify for 
the return of a fee claimed to have been paid in error 
under this section, a person shall submit to the Secretary 
a written request justifying such return within 180 cal-
endar days after such fee was paid. 
‘‘(n) SUBSTANTIALLY COMPLETE APPLICATIONS.— 
An abbreviated new drug application that is not consid-
ered to be received within the meaning of section 
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505(j)(5)(A) because of failure to pay an applicable fee 
under this provision within the time period specified in 
subsection (g) shall be deemed not to have been ‘substan-
tially complete’ on the date of its submission within the 
meaning of section 505(j)(5)(B)(iv)(II)(cc). An abbre-
viated new drug application that is not substantially com-
plete on the date of its submission solely because of failure 
to pay an applicable fee under the preceding sentence shall 
be deemed substantially complete and received within the 
meaning of section 505(j)(5)(A) as of the date such appli-
cable fee is received.’’. 
SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Part 7 of subchapter C of chapter VII, as added by 
section 302 of this Act, is amended by inserting after sec-
tion 744B the following: 
‘‘SEC. 744C. REAUTHORIZATION; REPORTING REQUIRE-
MENTS. 
‘‘(a) PERFORMANCE REPORT.— 
‘‘(1) IN GENERAL.—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 re-
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port concerning the progress of the Food and Drug 
Administration in achieving the goals identified in 
the letters described in section 301(b) of the Generic 
Drug User Fee Amendments of 2012 during such 
fiscal year and the future plans of the Food and 
Drug Administration for meeting the goals. 
‘‘(2) REGULATORY
SCIENCE
ACCOUNTABILITY 
METRICS.—The report required by paragraph (1) 
shall describe the amounts spent, data generated, 
and activities undertaken, including any FDA Advi-
sory Committee consideration, by the Secretary for 
each of the local acting bioequivalence topics (Topics 
1–3) in the Regulatory Science Plan described in the 
letters described in section 301(b) of the Generic 
Drug User Fee Amendments of 2012. 
‘‘(b) FISCAL 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 Sec-
retary shall prepare and submit to the Committee on En-
ergy and Commerce of the House of Representatives and 
the Committee on Health, Education, Labor, and Pen-
sions 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. 
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‘‘(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) REAUTHORIZATION.— 
‘‘(1) 
CONSULTATION.—In 
developing 
rec-
ommendations to present to the Congress with re-
spect to the goals, and plans for meeting the goals, 
for human generic drug activities for the first 5 fis-
cal years after fiscal year 2017, and for the reau-
thorization of this part for such fiscal years, the Sec-
retary 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; 
‘‘(E) representatives of patient and con-
sumer advocacy groups; and 
‘‘(F) the generic drug industry. 
‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning 
negotiations with the generic drug industry on the 
reauthorization of this part, the Secretary shall— 
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‘‘(A) publish a notice in the Federal Reg-
ister requesting public input on the reauthoriza-
tion; 
‘‘(B) hold a public meeting at which the 
public may present its views on the reauthoriza-
tion, including specific suggestions for changes 
to the goals referred to in subsection (a); 
‘‘(C) provide a period of 30 days after the 
public meeting to obtain written comments from 
the public suggesting changes to this part; and 
‘‘(D) publish the comments on the Food 
and Drug Administration’s Internet Web site. 
‘‘(3) PERIODIC CONSULTATION.—Not less fre-
quently than once every month during negotiations 
with the generic drug industry, the Secretary shall 
hold discussions with representatives of patient and 
consumer advocacy groups to continue discussions of 
their views on the reauthorization and their sugges-
tions for changes to this part as expressed under 
paragraph (2). 
‘‘(4) 
PUBLIC
REVIEW
OF
RECOMMENDA-
TIONS.—After negotiations with the generic drug in-
dustry, the Secretary shall— 
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‘‘(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. 
‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.— 
Not later than January 15, 2017, the Secretary 
shall transmit to the Congress the revised rec-
ommendations under paragraph (4), 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. 
‘‘(6) MINUTES OF NEGOTIATION MEETINGS.— 
‘‘(A) PUBLIC AVAILABILITY.—Before pre-
senting the recommendations developed under 
paragraphs (1) through (5) to the Congress, the 
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Secretary shall make publicly available, on the 
Internet Web site of the Food and Drug Ad-
ministration, minutes of all negotiation meet-
ings conducted under this subsection between 
the Food and Drug Administration and the ge-
neric drug industry. 
‘‘(B) CONTENT.—The minutes described 
under subparagraph (A) shall summarize any 
substantive proposal made by any party to the 
negotiations as well as significant controversies 
or differences of opinion during the negotiations 
and their resolution.’’. 
SEC. 304. SUNSET DATES. 
(a) AUTHORIZATION.—Sections 744A and 744B, as 
added by section 302 of this Act, are repealed October 
1, 2017. 
(b) REPORTING REQUIREMENTS.—Section 744C, as 
added by section 303 of this Act, is repealed January 31, 
2018. 
SEC. 305. EFFECTIVE DATE. 
The amendments made by this title shall take effect 
on October 1, 2012, or the date of the enactment of this 
title, whichever is later, except that fees under section 302 
shall be assessed for all human generic drug submissions 
and Type II active pharmaceutical drug master files re-
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ceived on or after October 1, 2012, regardless of the date 
of enactment of this title. 
SEC. 306. AMENDMENT WITH RESPECT TO MISBRANDING. 
Section 502 (21 U.S.C. 352) is amended by adding 
at the end the following: 
‘‘(aa) If it is a drug, or an active pharmaceutical in-
gredient, and it was manufactured, prepared, propagated, 
compounded, or processed in a facility for which fees have 
not been paid as required by section 744A(a)(4) or for 
which identifying information required by section 744B(f) 
has not been submitted, or it contains an active pharma-
ceutical ingredient that was manufactured, prepared, 
propagated, compounded, or processed in such a facility.’’. 
SEC. 307. STREAMLINED HIRING AUTHORITY TO SUPPORT 
ACTIVITIES RELATED TO HUMAN GENERIC 
DRUGS. 
Section 714, as added by section 208 of this Act, is 
amended— 
(1) by amending subsection (b) to read as fol-
lows: 
‘‘(b) ACTIVITIES DESCRIBED.—The activities de-
scribed in this subsection are— 
‘‘(1) activities under this Act related to the 
process for the review of device applications (as de-
fined in section 737(8)); and 
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‘‘(2) activities under this Act related to human 
generic drug activities (as defined in section 
744A).’’; and 
(2) by amending subsection (c) to read as fol-
lows: 
‘‘(c) OBJECTIVES SPECIFIED.—The objectives speci-
fied in this subsection are— 
‘‘(1) with respect to the activities under sub-
section (b)(1), the goals referred to in section 
738A(a)(1); and 
‘‘(2) with respect to the activities under sub-
section (b)(2), the goals referred to in section 
744C(a).’’. 
TITLE IV—FEES RELATING TO 
BIOSIMILAR 
BIOLOGICAL 
PRODUCTS 
SEC. 401. SHORT TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the 
‘‘Biosimilar User Fee Act of 2012’’. 
(b) FINDING.—The Congress finds that the fees au-
thorized by the amendments made in this title will be dedi-
cated to expediting the process for the review of biosimilar 
biological product applications, including postmarket safe-
ty activities, as set forth in the goals identified for pur-
poses of part 8 of subchapter C of chapter VII of the Fed-
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eral Food, Drug, and Cosmetic Act, in the letters from 
the Secretary of Health and Human Services to the Chair-
man of the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Chairman of the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives, as set forth in the Congressional Record. 
SEC. 402. FEES RELATING TO BIOSIMILAR BIOLOGICAL 
PRODUCTS. 
Subchapter C of chapter VII (21 U.S.C. 379f et seq.) 
is amended by inserting after part 7, as added by title 
III of this Act, the following: 
‘‘PART 8—FEES RELATING TO BIOSIMILAR 
BIOLOGICAL PRODUCTS 
‘‘SEC. 744G. DEFINITIONS. 
‘‘For purposes of this part: 
‘‘(1) The term ‘adjustment factor’ applicable to 
a fiscal year that is the Consumer Price Index for 
all urban consumers (Washington-Baltimore, DC– 
MD–VA–WV; Not Seasonally Adjusted; All items) of 
the preceding fiscal year divided by such Index for 
September 2011. 
‘‘(2) The term ‘affiliate’ means a business enti-
ty that has a relationship with a second business en-
tity if, directly or indirectly— 
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‘‘(A) one business entity controls, or has 
the power to control, the other business entity; 
or 
‘‘(B) a third party controls, or has power 
to control, both of the business entities. 
‘‘(3) The term ‘biosimilar biological product’ 
means a product for which a biosimilar biological 
product application has been approved. 
‘‘(4)(A) Subject to subparagraph (B), the term 
‘biosimilar biological product application’ means an 
application for licensure of a biological product 
under section 351(k) of the Public Health Service 
Act. 
‘‘(B) Such term does not include— 
‘‘(i) a supplement to such an application; 
‘‘(ii) an application filed under section 
351(k) of the Public Health Service Act that 
cites as the reference product a bovine blood 
product for topical application licensed before 
September 1, 1992, or a large volume paren-
teral drug product approved before such date; 
‘‘(iii) an application filed under section 
351(k) of the Public Health Service Act with 
respect to— 
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‘‘(I) whole blood or a blood component 
for transfusion; 
‘‘(II) an allergenic extract product; 
‘‘(III) an in vitro diagnostic biological 
product; or 
‘‘(IV) a biological product for further 
manufacturing use only; or 
‘‘(iv) an application for licensure under 
section 351(k) of the Public Health Service Act 
that is submitted by a State or Federal Govern-
ment entity for a product that is not distributed 
commercially. 
‘‘(5) The term ‘biosimilar biological product de-
velopment meeting’ means any meeting, other than 
a biosimilar initial advisory meeting, regarding the 
content of a development program, including a pro-
posed design for, or data from, a study intended to 
support a biosimilar biological product application. 
‘‘(6) The term ‘biosimilar biological product de-
velopment program’ means the program under this 
part for expediting the process for the review of sub-
missions in connection with biosimilar biological 
product development. 
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‘‘(7)(A) The term ‘biosimilar biological product 
establishment’ means a foreign or domestic place of 
business— 
‘‘(i) that is at one general physical location 
consisting of one or more buildings, all of which 
are within five miles of each other; and 
‘‘(ii) at which one or more biosimilar bio-
logical products are manufactured in final dos-
age form. 
‘‘(B) For purposes of subparagraph (A)(ii), the 
term ‘manufactured’ does not include packaging. 
‘‘(8) The term ‘biosimilar initial advisory meet-
ing’— 
‘‘(A) means a meeting, if requested, that is 
limited to— 
‘‘(i) a general discussion regarding 
whether licensure under section 351(k) of 
the Public Health Service Act may be fea-
sible for a particular product; and 
‘‘(ii) if so, general advice on the ex-
pected content of the development pro-
gram; and 
‘‘(B) does not include any meeting that in-
volves substantive review of summary data or 
full study reports. 
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‘‘(9) The term ‘costs of resources allocated for 
the process for the review of biosimilar biological 
product applications’ means the expenses in connec-
tion with the process for the review of biosimilar bio-
logical product applications for— 
‘‘(A) officers and employees of the Food 
and Drug Administration, contractors of the 
Food and Drug Administration, advisory com-
mittees, and costs related to such officers em-
ployees and committees and to contracts with 
such contractors; 
‘‘(B) management of information, and the 
acquisition, maintenance, and repair of com-
puter resources; 
‘‘(C) leasing, maintenance, renovation, and 
repair of facilities and acquisition, maintenance, 
and repair of fixtures, furniture, scientific 
equipment, and other necessary materials and 
supplies; and 
‘‘(D) collecting fees under section 744H 
and accounting for resources allocated for the 
review of submissions in connection with bio-
similar biological product development, bio-
similar biological product applications, and sup-
plements. 
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‘‘(10) The term ‘final dosage form’ means, with 
respect to a biosimilar biological product, a finished 
dosage form which is approved for administration to 
a patient without substantial further manufacturing 
(such as lyophilized products before reconstitution). 
‘‘(11) The term ‘financial hold’— 
‘‘(A) means an order issued by the Sec-
retary to prohibit the sponsor of a clinical in-
vestigation from continuing the investigation if 
the Secretary determines that the investigation 
is intended to support a biosimilar biological 
product application and the sponsor has failed 
to pay any fee for the product required under 
subparagraph (A), (B), or (D) of section 
744H(a)(1); and 
‘‘(B) does not mean that any of the bases 
for a ‘clinical hold’ under section 505(i)(3) have 
been determined by the Secretary to exist con-
cerning the investigation. 
‘‘(12) The term ‘person’ includes an affiliate of 
such person. 
‘‘(13) The term ‘process for the review of bio-
similar biological product applications’ means the 
following activities of the Secretary with respect to 
the review of submissions in connection with bio-
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similar biological product development, biosimilar bi-
ological product applications, and supplements: 
‘‘(A) The activities necessary for the re-
view of submissions in connection with bio-
similar biological product development, bio-
similar biological product applications, and sup-
plements. 
‘‘(B) Actions related to submissions in con-
nection with biosimilar biological product devel-
opment, the issuance of action letters which ap-
prove biosimilar biological product applications 
or which set forth in detail the specific defi-
ciencies in such applications, and where appro-
priate, the actions necessary to place such ap-
plications in condition for approval. 
‘‘(C) The inspection of biosimilar biological 
product establishments and other facilities un-
dertaken as part of the Secretary’s review of 
pending biosimilar biological product applica-
tions and supplements. 
‘‘(D) Activities necessary for the release of 
lots of biosimilar biological products under sec-
tion 351(k) of the Public Health Service Act. 
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‘‘(E) Monitoring of research conducted in 
connection with the review of biosimilar biologi-
cal product applications. 
‘‘(F) Postmarket safety activities with re-
spect to biologics approved under biosimilar bio-
logical product applications or supplements, in-
cluding the following activities: 
‘‘(i) Collecting, developing, and re-
viewing safety information on biosimilar bi-
ological products, including adverse-event 
reports. 
‘‘(ii) Developing and using improved 
adverse-event data-collection systems, in-
cluding information technology systems. 
‘‘(iii) Developing and using improved 
analytical tools to assess potential safety 
problems, including access to external data 
bases. 
‘‘(iv) Implementing and enforcing sec-
tion 505(o) (relating to postapproval stud-
ies and clinical trials and labeling changes) 
and section 505(p) (relating to risk evalua-
tion and mitigation strategies). 
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‘‘(v) Carrying out section 505(k)(5) 
(relating to adverse-event reports and 
postmarket safety activities). 
‘‘(14) The term ‘supplement’ means a request 
to the Secretary to approve a change in a biosimilar 
biological product application which has been ap-
proved, including a supplement requesting that the 
Secretary determine that the biosimilar biological 
product meets the standards for interchangeability 
described in section 351(k)(4) of the Public Health 
Service Act. 
‘‘SEC. 744H. AUTHORITY TO ASSESS AND USE BIOSIMILAR 
BIOLOGICAL PRODUCT FEES. 
‘‘(a) TYPES
OF FEES.—Beginning in fiscal year 
2013, the Secretary shall assess and collect fees in accord-
ance with this section as follows: 
‘‘(1) 
BIOSIMILAR
DEVELOPMENT
PROGRAM 
FEES.— 
‘‘(A) 
INITIAL
BIOSIMILAR
BIOLOGICAL 
PRODUCT DEVELOPMENT FEE.— 
‘‘(i) IN GENERAL.—Each person that 
submits to the Secretary a meeting request 
described under clause (ii) or a clinical 
protocol for an investigational new drug 
protocol described under clause (iii) shall 
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pay for the product named in the meeting 
request or the investigational new drug ap-
plication the initial biosimilar biological 
product development fee established under 
subsection (b)(1)(A). 
‘‘(ii) MEETING REQUEST.—The meet-
ing request defined in this clause is a re-
quest for a biosimilar biological product 
development meeting for a product. 
‘‘(iii) CLINICAL PROTOCOL FOR IND.— 
A clinical protocol for an investigational 
new drug protocol described in this clause 
is a clinical protocol consistent with the 
provisions of section 505(i), including any 
regulations promulgated under section 
505(i), (referred to in this section as ‘in-
vestigational new drug application’) de-
scribing an investigation that the Secretary 
determines is intended to support a bio-
similar biological product application for a 
product. 
‘‘(iv) DUE
DATE.—The initial bio-
similar biological product development fee 
shall be due by the earlier of the following: 
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Act providing for the collection and 
obligation of fees for such year under 
this section. 
‘‘(iii) EXCEPTION.—The annual bio-
similar development program fee for each 
fiscal year will be due on the date specified 
in clause (ii), unless the person has— 
‘‘(I) submitted a marketing appli-
cation for the biological product that 
was accepted for filing; or 
‘‘(II) discontinued participation 
in the biosimilar biological product de-
velopment program for the product 
under subparagraph (C). 
‘‘(C) DISCONTINUATION OF FEE OBLIGA-
TION.—A person may discontinue participation 
in the biosimilar biological product development 
program for a product effective October 1 of a 
fiscal year by, not later than August 1 of the 
preceding fiscal year— 
‘‘(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 
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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-
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 
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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-
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. 
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100 
‘‘(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-
vestigation from continuing the investiga-
tion if— 
‘‘(I) the Secretary determines 
that the investigation is intended to 
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101 
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 
Secretary until all such fees owed by such 
person have been paid. 
‘‘(F) LIMITS REGARDING BIOSIMILAR DE-
VELOPMENT PROGRAM FEES.— 
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102 
‘‘(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: 
‘‘(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 
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103 
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. 
‘‘(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 
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104 
under subsection (b)(1)(D) for a biosimilar 
biological product application. 
‘‘(B) 
REDUCTION
IN
FEES.—Notwith-
standing section 404 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. 
‘‘(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 
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105 
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-
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). 
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106 
‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT ESTAB-
LISHMENT FEE.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (E), each person that is named 
as the applicant in a biosimilar biological prod-
uct application shall be assessed an annual fee 
established under subsection (b)(1)(E) for each 
biosimilar biological product establishment that 
is listed in the approved biosimilar biological 
product application as an establishment that 
manufactures the biosimilar biological 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. 
‘‘(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 
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107 
‘‘(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 
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 
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108 
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 
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— 
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119 
‘‘(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. 
‘‘(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-
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