the sum of all adjustments made each fiscal year 
after fiscal year 2013 under this subsection. 
‘‘(2) FINAL
YEAR
ADJUSTMENT.—For fiscal 
year 2017, the Secretary may, in addition to adjust-
ments under paragraph (1), further increase the fee 
revenues and fees established in subsection (b) if 
such an adjustment is necessary to provide for not 
more than 3 months of operating reserves of carry-
over user fees for human generic drug activities for 
the first 3 months of fiscal year 2018. Such fees 
may only be used in fiscal year 2018. If such an ad-
justment is necessary, the rationale for the amount 
of the increase shall be contained in the annual no-
tice establishing fee revenues and fees for fiscal year 
2017. If the Secretary has carryover balances for 
such activities in excess of 3 months of such oper-
ating reserves, the adjustment under this subpara-
graph shall not be made. 
‘‘(d) ANNUAL FEE SETTING.— 
‘‘(1) FISCAL
YEAR
2013.—For fiscal year 
2013— 
‘‘(A) the Secretary shall establish, by Octo-
ber 31, 2012, the one-time generic drug backlog 
fee for generic drug applications pending on Oc-
tober 1, 2012, the drug master file fee, the ab-
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breviated new drug application fee, and the 
prior approval supplement fee under subsection 
(a), based on the revenue amounts established 
under subsection (b); and 
‘‘(B) the Secretary shall establish, not 
later than 45 days after the date to comply 
with the requirement for identification of facili-
ties in subsection (f)(2), the generic drug facil-
ity fee and active pharmaceutical ingredient fa-
cility fee under subsection (a) based on the rev-
enue amounts established under subsection (b). 
‘‘(2) FISCAL YEARS 2014 THROUGH 2017.—Not 
more than 60 days before the first day of each of 
fiscal years 2014 through 2017, the Secretary shall 
establish the drug master file fee, the abbreviated 
new drug application fee, the prior approval supple-
ment fee, the generic drug facility fee, and the active 
pharmaceutical ingredient facility fee under sub-
section (a) for such fiscal year, based on the revenue 
amounts established under subsection (b) and the 
adjustments provided under subsection (c). 
‘‘(3) FEE
FOR
ACTIVE
PHARMACEUTICAL
IN-
GREDIENT INFORMATION NOT INCLUDED BY REF-
ERENCE TO TYPE II ACTIVE PHARMACEUTICAL IN-
GREDIENT DRUG MASTER FILE.—In establishing the 
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fees under paragraphs (1) and (2), the amount of 
the fee under subsection (a)(3)(F) shall be deter-
mined by multiplying— 
‘‘(A) the sum of— 
‘‘(i) the total number of such active 
pharmaceutical ingredients in such submis-
sion; and 
‘‘(ii) for each such ingredient that is 
manufactured at more than one such facil-
ity, the total number of such additional fa-
cilities; and 
‘‘(B) the amount equal to the drug master 
file fee established in subsection (a)(2) for such 
submission. 
‘‘(e) LIMIT.—The total amount of fees charged, as 
adjusted under subsection (c), for a fiscal year may not 
exceed the total costs for such fiscal year for the resources 
allocated for human generic drug activities. 
‘‘(f) IDENTIFICATION OF FACILITIES.— 
‘‘(1) PUBLICATION OF NOTICE; DEADLINE FOR 
COMPLIANCE.—Not later than October 1, 2012, the 
Secretary shall cause to be published in the Federal 
Register a notice requiring each person that owns a 
facility described in subsection (a)(4)(A), or a site or 
organization required to be identified by paragraph 
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(4), to submit to the Secretary information on the 
identity of each such facility, site, or organization. 
The notice required by this paragraph shall specify 
the type of information to be submitted and the 
means and format for submission of such informa-
tion. 
‘‘(2) REQUIRED
SUBMISSION
OF
FACILITY 
IDENTIFICATION.—Each person that owns a facility 
described in subsection (a)(4)(A) or a site or organi-
zation required to be identified by paragraph (4) 
shall submit to the Secretary the information re-
quired under this subsection each year. Such infor-
mation shall— 
‘‘(A) for fiscal year 2013, be submitted not 
later than 60 days after the publication of the 
notice under paragraph (1); and 
‘‘(B) for each subsequent fiscal year, be 
submitted, updated, or reconfirmed on or before 
June 1 of such year. 
‘‘(3) CONTENTS OF NOTICE.—At a minimum, 
the submission required by paragraph (2) shall in-
clude for each such facility— 
‘‘(A) identification of a facility identified or 
intended to be identified in an approved or 
pending generic drug submission; 
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‘‘(B) whether the facility manufactures ac-
tive pharmaceutical ingredients or finished dos-
age forms, or both; 
‘‘(C) whether or not the facility is located 
within the United States and its territories and 
possessions; 
‘‘(D) whether the facility manufactures 
positron emission tomography drugs solely, or 
in addition to other drugs; and 
‘‘(E) whether the facility manufactures 
drugs that are not generic drugs. 
‘‘(4) CERTAIN SITES AND ORGANIZATIONS.— 
‘‘(A) IN GENERAL.—Any person that owns 
or operates a site or organization described in 
subparagraph (B) shall submit to the Secretary 
information concerning the ownership, name, 
and address of the site or organization. 
‘‘(B) SITES AND ORGANIZATIONS.—A site 
or organization is described in this subpara-
graph if it is identified in a generic drug sub-
mission and is— 
‘‘(i) a site in which a bioanalytical 
study is conducted; 
‘‘(ii) a clinical research organization; 
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‘‘(iii) a contract analytical testing site; 
or 
‘‘(iv) a contract repackager site. 
‘‘(C) NOTICE.—The Secretary may, by no-
tice published in the Federal Register, specify 
the means and format for submission of the in-
formation under subparagraph (A) and may 
specify, as necessary for purposes of this sec-
tion, any additional information to be sub-
mitted. 
‘‘(D) INSPECTION AUTHORITY.—The Sec-
retary’s inspectional authority under section 
704(a)(1) shall extend to all such sites and or-
ganizations. 
‘‘(g) EFFECT OF FAILURE TO PAY FEES.— 
‘‘(1) GENERIC DRUG BACKLOG FEE.—Failure 
to pay the fee under subsection (a)(1) shall result in 
the Secretary placing the person that owns the ab-
breviated new drug application subject to that fee on 
an arrears list, such that no new abbreviated new 
drug applications or supplement submitted on or 
after October 1, 2012, from that person, or any af-
filiate of that person, will be received within the 
meaning of section 505(j)(5)(A) until such out-
standing fee is paid. 
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‘‘(2) DRUG MASTER FILE FEE.— 
‘‘(A) Failure to pay the fee under sub-
section (a)(2) within 20 calendar days after the 
applicable due date under subparagraph (E) of 
such subsection (as described in subsection 
(a)(2)(D)(ii)(I)) shall result in the Type II ac-
tive pharmaceutical ingredient drug master file 
not being deemed available for reference. 
‘‘(B)(i) Any generic drug submission sub-
mitted on or after October 1, 2012, that ref-
erences, by a letter of authorization, a Type II 
active pharmaceutical ingredient drug master 
file that has not been deemed available for ref-
erence shall not be received within the meaning 
of section 505(j)(5)(A) unless the condition 
specified in clause (ii) is met. 
‘‘(ii) The condition specified in this clause 
is that the fee established under subsection 
(a)(2) has been paid within 20 calendar days of 
the Secretary providing the notification to the 
sponsor of the abbreviated new drug application 
or supplement of the failure of the owner of the 
Type II active pharmaceutical ingredient drug 
master file to pay the drug master file fee as 
specified in subparagraph (C). 
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‘‘(C)(i) If an abbreviated new drug applica-
tion or supplement to an abbreviated new drug 
application references a Type II active pharma-
ceutical ingredient drug master file for which a 
fee under subsection (a)(2)(A) has not been 
paid by the applicable date under subsection 
(a)(2)(E), the Secretary shall notify the sponsor 
of the abbreviated new drug application or sup-
plement of the failure of the owner of the Type 
II active pharmaceutical ingredient drug master 
file to pay the applicable fee. 
‘‘(ii) If such fee is not paid within 20 cal-
endar days of the Secretary providing the noti-
fication, the abbreviated new drug application 
or supplement to an abbreviated new drug ap-
plication shall not be received within the mean-
ing of 505(j)(5)(A). 
‘‘(3) ABBREVIATED
NEW
DRUG
APPLICATION 
FEE
AND
PRIOR
APPROVAL
SUPPLEMENT
FEE.— 
Failure to pay a fee under subparagraph (A) or (F) 
of subsection (a)(3) within 20 calendar days of the 
applicable due date under subparagraph (C) of such 
subsection shall result in the abbreviated new drug 
application or the prior approval supplement to an 
abbreviated new drug application not being received 
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within the meaning of section 505(j)(5)(A) until 
such outstanding fee is paid. 
‘‘(4) GENERIC DRUG FACILITY FEE AND ACTIVE 
PHARMACEUTICAL INGREDIENT FACILITY FEE.— 
‘‘(A) IN GENERAL.—Failure to pay the fee 
under subsection (a)(4) within 20 calendar days 
of the due date as specified in subparagraph 
(D) of such subsection shall result in the fol-
lowing: 
‘‘(i) The Secretary shall place the fa-
cility on a publicly available arrears list, 
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 
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 
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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 
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 
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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 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 
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 
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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 
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 
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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 
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 subsection (p)(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. 
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‘‘(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. 
‘‘(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. 
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‘‘(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 
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 
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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 
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. 103. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Part 7 of subchapter C of chapter VII, as added by 
section 102 of this Act, is amended by inserting after sec-
tion 744B the following: 
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‘‘SEC. 744C. 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 101(c) 
of the Generic Drug User Fee Amendments of 2012 dur-
ing such fiscal year and the future plans of the Food and 
Drug Administration for meeting the goals. 
‘‘(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. 
‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall 
make the reports required under subsections (a) and (b) 
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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— 
‘‘(A) publish a notice in the Federal Reg-
ister requesting public input on the reauthoriza-
tion; 
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‘‘(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— 
‘‘(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; 
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‘‘(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 
Secretary shall make publicly available, on the 
public Web site of the Food and Drug Adminis-
tration, minutes of all negotiation meetings con-
ducted under this subsection between the Food 
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and Drug Administration and the generic 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. 104. SUNSET DATES. 
(a) AUTHORIZATION.—The amendments made by 
section 102 cease to be effective October 1, 2017. 
(b) REPORTING REQUIREMENTS.—The amendments 
made by section 103 cease to be effective January 31, 
2018. 
SEC. 105. 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 102 
shall be assessed for all human generic drug submissions 
and Type II active pharmaceutical drug master files re-
ceived on or after October 1, 2012, regardless of the date 
of enactment of this title. 
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SEC. 106. AMENDMENT WITH RESPECT TO MISBRANDING. 
Section 502 of the Federal Food, Drug, and Cosmetic 
Act (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. 107. ELECTRONIC SUBMISSION OF APPLICATIONS. 
The Federal Food, Drug, and Cosmetic Act is amend-
ed by inserting after section 745 the following: 
‘‘SEC. 745A. ELECTRONIC SUBMISSION OF APPLICATIONS:. 
‘‘(a) IN GENERAL.—Beginning no earlier than 24 
months after the issuance of a final guidance issued after 
public notice and opportunity for comment, submissions 
under section 505(j) shall be submitted in such electronic 
format as specified by the Secretary in such guidance. 
‘‘(b) GUIDANCE CONTENTS.—In such guidance, the 
Secretary may provide a timetable for establishment by 
the Secretary of further standards for such electronic sub-
mission, and set forth criteria for waivers of and exemp-
tions from the requirements of this section. 
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‘‘(c) EXCEPTION.—This section shall not apply to 
submissions described in section 561.’’. 
SEC. 108. STREAMLINED HIRING AUTHORITY OF THE FOOD 
AND DRUG ADMINISTRATION TO SUPPORT 
ACTIVITIES RELATED TO HUMAN GENERIC 
DRUGS. 
Subchapter A of chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amend-
ed by inserting after section 713 the following new section: 
‘‘SEC. 714. STREAMLINED HIRING AUTHORITY. 
‘‘(a) IN GENERAL.—In addition to any other per-
sonnel authorities under other provisions of law, the Sec-
retary may, without regard to the provisions of title 5, 
United States Code, governing appointments in the com-
petitive service, appoint employees to positions in the Food 
and Drug Administration to perform, administer, or sup-
port activities described in subsection (b), if the Secretary 
determines that such appointments are needed to achieve 
the objectives specified in subsection (c). 
‘‘(b) ACTIVITIES DESCRIBED.—The activities de-
scribed in this subsection are activities under this Act re-
lated to human generic drug activities (as defined in sec-
tion 744A). 
‘‘(c) OBJECTIVES SPECIFIED.—The objectives speci-
fied in this subsection are the performance goals with re-
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‘‘(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 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— 
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