day when transmission to that electronic gate-
way is completed, except that a submission or 
master file that arrives on a weekend, Federal 
holiday, or day when the Food and Drug Ad-
ministration office that will review that submis-
sion is not otherwise open for business shall be 
deemed to be submitted on the next day when 
that office is open for business; and 
‘‘(B) if it is submitted in physical media 
form, on the day it arrives at the appropriate 
designated document room of the Food and 
Drug Administration. 
‘‘(b) FEE REVENUE AMOUNTS.— 
‘‘(1) IN GENERAL.— 
‘‘(A) FISCAL YEAR 2013.—For fiscal year 
2013, fees under subsection (a) shall be estab-
lished to generate a total estimated revenue 
amount under such subsection of $299,000,000. 
Of that amount— 
‘‘(i) $50,000,000 shall be generated 
by the one-time backlog fee for generic 
drug applications pending on October 1, 
2012, established in subsection (a)(1); and
‘‘(ii) $249,000,000 shall be generated 
by the fees under paragraphs (2) through 
(4) of subsection (a). 
‘‘(B) FISCAL YEARS 2014 THROUGH 2017.— 
For each of the fiscal years 2014 through 2017, 
fees under paragraphs (2) through (4) of sub-
section (a) shall be established to generate a 
total estimated revenue amount under such sub-
section that is equal to $299,000,000, as ad-
justed pursuant to subsection (c). 
‘‘(2) TYPES
OF
FEES.—In establishing fees 
under paragraph (1) to generate the revenue 
amounts specified in paragraph (1)(A)(ii) for fiscal 
year 2013 and paragraph (1)(B) for each of fiscal 
years 2014 through 2017, such fees shall be derived 
from the fees under paragraphs (2) through (4) of 
subsection (a) as follows: 
‘‘(A) 6 percent shall be derived from fees 
under subsection (a)(2) (relating to drug mas-
ter files). 
‘‘(B) 24 percent shall be derived from fees 
under subsection (a)(3) (relating to abbreviated 
new drug applications and supplements). The 
amount of a fee for a prior approval supplement
shall be half the amount of the fee for an ab-
breviated new drug application. 
‘‘(C) 56 percent shall be derived from fees 
under subsection (a)(4)(A)(i) (relating to ge-
neric drug facilities). The amount of the fee for 
a facility located outside the United States and 
its territories and possessions shall be not less 
than $15,000 and not more than $30,000 high-
er than the amount of the fee for a facility lo-
cated in the United States and its territories 
and possessions, as determined by the Secretary 
on the basis of data concerning the difference 
in cost between inspections of facilities located 
in the United States, including its territories 
and possessions, and those located outside of 
the United States and its territories and posses-
sions. 
‘‘(D) 14 percent shall be derived from fees 
under subsection (a)(4)(A)(ii) (relating to active 
pharmaceutical 
ingredient 
facilities). 
The 
amount of the fee for a facility located outside 
the United States and its territories and posses-
sions shall be not less than $15,000 and not 
more than $30,000 higher than the amount of 
the fee for a facility located in the United
States, including its territories and possessions, 
as determined by the Secretary on the basis of 
data concerning the difference in cost between 
inspections of facilities located in the United 
States and its territories and possessions and 
those located outside of the United States and 
its territories and possessions. 
‘‘(c) ADJUSTMENTS.— 
‘‘(1) INFLATION ADJUSTMENT.—For fiscal year 
2014 and subsequent fiscal years, the revenues es-
tablished in subsection (b) shall be adjusted by the 
Secretary by notice, published in the Federal Reg-
ister, for a fiscal year, by an amount equal to the 
sum of— 
‘‘(A) one; 
‘‘(B) the average annual percent change in 
the cost, per full-time equivalent position of the 
Food and Drug Administration, of all personnel 
compensation and benefits paid with respect to 
such positions for the first 3 years of the pre-
ceding 4 fiscal years multiplied by the propor-
tion of personnel compensation and benefits 
costs to total costs of human generic drug ac-
tivities for the first 3 years of the preceding 4 
fiscal years; and
‘‘(C) the average annual percent change 
that occurred in the Consumer Price Index for 
urban consumers (Washington-Baltimore, DC– 
MD–VA–WV; Not Seasonally Adjusted; All 
items; Annual Index) for the first 3 years of the 
preceding 4 years of available data multiplied 
by the proportion of all costs other than per-
sonnel compensation and benefits costs to total 
costs of human generic drug activities for the 
first 3 years of the preceding 4 fiscal years. 
The adjustment made each fiscal year under this 
subsection shall be added on a compounded basis to 
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-
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 
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 
(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 the previous 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; 
‘‘(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; 
‘‘(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 inspection 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. 
‘‘(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). 
‘‘(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 
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,
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
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
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
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.
‘‘(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
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
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-
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.
‘‘(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—
‘‘(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—
‘‘(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
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-
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
‘‘(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-
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—
‘‘(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—
‘‘(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.
‘‘(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.
‘‘(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-
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.
‘‘(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).
‘‘(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
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:
‘‘(I) Not later than 5 days after 
the Secretary grants a request for a 
biosimilar biological product develop-
ment meeting. 
‘‘(II) The date of submission of 
an investigational new drug applica-
tion describing an investigation that 
the Secretary determines is intended 
to support a biosimilar biological 
product application. 
‘‘(v) TRANSITION
RULE.—Each per-
son that has submitted an investigational 
new drug application prior to the date of 
enactment of the Biosimilars User Fee Act 
of 2012 shall pay the initial biosimilar bio-
logical product development fee by the ear-
lier of the following: 
‘‘(I) Not later than 60 days after 
the date of the enactment of the 
Biosimilars User Fee Act of 2012, if 
the Secretary determines that the in-
vestigational new drug application de-
scribes an investigation that is in-
tended to support a biosimilar biologi-
cal product application.
‘‘(II) Not later than 5 days after 
the Secretary grants a request for a 
biosimilar biological product develop-
ment meeting. 
‘‘(B) ANNUAL
BIOSIMILAR
BIOLOGICAL 
PRODUCT DEVELOPMENT FEE.— 
‘‘(i) IN
GENERAL.—A person that 
pays an initial biosimilar biological product 
development fee for a product shall pay for 
such product, beginning in the fiscal year 
following the fiscal year in which the initial 
biosimilar biological product development 
fee was paid, an annual fee established 
under subsection (b)(1)(B) for biosimilar 
biological product development (referred to 
in this section as ‘annual biosimilar bio-
logical product development fee’). 
‘‘(ii) DUE
DATE.—The annual bio-
similar biological product development pro-
gram fee for each fiscal year will 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 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
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
100 
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.
101 
‘‘(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
102 
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.—
103 
‘‘(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 
a biosimilar biological product applica-
104 
tion for which clinical data (other 
than comparative bioavailability stud-
ies) with respect to safety or effective-
ness are required for approval; 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
105 
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 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
106 
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-
ing, shall be subject to the full fee under sub-
paragraph (A) upon being resubmitted or filed
107 
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), 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—
108 
‘‘(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 
biosimilar biological product fees under 
paragraph (4).
109 
‘‘(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 
biosimilar biological product the annual fee es-
tablished under subsection (b)(1)(F).
110 
‘‘(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 
subsection (a)(1)(A) for a fiscal year shall be 
equal to 10 percent of the amount established
111 
under section 736(c)(4) 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)(4) for a human 
drug 
application 
described 
in 
section 
736(a)(1)(A)(i) for that fiscal year. 
‘‘(C) REACTIVATION
FEE.—The reactiva-
tion fee under subsection (a)(1)(D) for a fiscal 
year shall be equal to 20 percent of the amount 
of the fee established under section 736(c)(4) 
for a human drug application described in sec-
tion 736(a)(1)(A)(i) for that fiscal year. 
‘‘(D) BIOSIMILAR
BIOLOGICAL
PRODUCT 
APPLICATION
FEE.—The biosimilar biological 
product application fee under subsection (a)(2) 
for a fiscal year shall be equal to the amount 
established under section 736(c)(4) for a 
human drug application described in section 
736(a)(1)(A)(i) for that fiscal year.
112 
‘‘(E) BIOSIMILAR
BIOLOGICAL
PRODUCT 
ESTABLISHMENT FEE.—The biosimilar biologi-
cal product establishment fee under subsection 
(a)(3) for a fiscal year shall be equal to the 
amount established under section 736(c)(4) for 
a prescription drug establishment for that fiscal 
year. 
‘‘(F) BIOSIMILAR
BIOLOGICAL
PRODUCT 
FEE.—The biosimilar biological product fee 
under subsection (a)(4) for a fiscal year shall be 
equal to the amount established under section 
736(c)(4) for a prescription drug product for 
that fiscal year. 
‘‘(2) LIMIT.—The total amount of fees charged 
for a fiscal year under this section may not exceed 
the total amount for such fiscal year of the costs of 
resources allocated for the process for the review of 
biosimilar biological product applications. 
‘‘(c) APPLICATION FEE WAIVER FOR SMALL BUSI-
NESS.— 
‘‘(1) WAIVER OF APPLICATION FEE.—The Sec-
retary shall grant to a person who is named in a bio-
similar biological product application a waiver from 
the application fee assessed to that person under 
subsection (a)(2)(A) for the first biosimilar biologi-
113 
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-
uct that has been approved under a human drug ap-
plication (as defined in section 735) or a biosimilar
114 
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. 
‘‘(2) 
COLLECTIONS
AND
APPROPRIATION 
ACTS.—
115 
‘‘(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 
of an Act making appropriations through Sep-
tember 30, 2013, for the salaries and expenses
116 
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. 
‘‘(g) WRITTEN REQUESTS FOR WAIVERS AND RE-
FUNDS.—To qualify for consideration for a waiver under
117 
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. 403. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Part 8 of subchapter C of chapter VII, as added by 
section 402 of this Act, is further amended by inserting 
after section 744H the following: 
‘‘SEC. 
744I. 
REAUTHORIZATION; 
REPORTING 
REQUIRE-
MENTS. 
‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal 
year 2013, not later than 120 days after the end of each 
fiscal year for which fees are collected under this part, 
the Secretary shall prepare and submit to the Committee 
on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report concerning the progress
118 
of the Food and Drug Administration in achieving the 
goals identified in the letters described in section 401(b) 
of the Biosimilar User Fee Act of 2012 during such fiscal 
year and the future plans of the Food and Drug Adminis-
tration for meeting such goals. The report for a fiscal year 
shall include information on all previous cohorts for which 
the Secretary has not given a complete response on all 
biosimilar biological product applications and supplements 
in the cohort. 
‘‘(b) FISCAL REPORT.—Not later than 120 days after 
the end of fiscal year 2013 and each subsequent fiscal year 
for which fees are collected under this part, the Secretary 
shall prepare and submit to the Committee on Energy and 
Commerce of the House of Representatives and the Com-
mittee on Health, Education, Labor, and Pensions of the 
Senate a report on the implementation of the authority 
for such fees during such fiscal year and the use, by the 
Food and Drug Administration, of the fees collected for 
such fiscal year. 
‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall 
make the reports required under subsections (a) and (b) 
available to the public on the Internet Web site of the 
Food and Drug Administration. 
‘‘(d) STUDY.—
119 
‘‘(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;
120 
‘‘(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.
121 
‘‘(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. 404. SUNSET DATES. 
(a) AUTHORIZATION.—Sections 744G and 744H, as 
added by section 402 of this Act, are repealed October 
1, 2017. 
(b) REPORTING REQUIREMENTS.—Section 744I, as 
added by section 403 of this Act, is repealed January 31, 
2018. 
SEC. 405. EFFECTIVE DATE. 
(a) IN GENERAL.—Except as provided under sub-
section (b), the amendments made by this title shall take 
effect on the later of— 
(1) October 1, 2012; or 
(2) the date of the enactment of this title. 
(b) EXCEPTION.—Fees under part 8 of subchapter 
C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, as added by this title, shall be assessed for all bio-
similar biological product applications received on or after
122 
October 1, 2012, regardless of the date of the enactment 
of this title. 
SEC. 406. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this title, 
part 2 of subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act, as in effect on the day before 
the date of the enactment of this title, shall continue to 
be in effect with respect to human drug applications and 
supplements (as defined in such part as of such day) that 
were accepted by the Food and Drug Administration for 
filing on or after October 1, 2007, but before October 1, 
2012, with respect to assessing and collecting any fee re-
quired by such part for a fiscal year prior to fiscal year 
2013. 
SEC. 407. CONFORMING AMENDMENT. 
Section 735(1)(B) (21 U.S.C. 379g(1)(B)) is amend-
ed by striking ‘‘or (k)’’.
123 
TITLE V—REAUTHORIZATION OF 
BEST 
PHARMACEUTICALS 
FOR CHILDREN ACT AND PE-
DIATRIC RESEARCH EQUITY 
ACT 
SEC. 501. PERMANENT EXTENSION OF BEST PHARMA-
CEUTICALS FOR CHILDREN ACT AND PEDI-
ATRIC RESEARCH EQUITY ACT. 
(a) PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.— 
Section 409I(c) of the Public Health Service Act (42 
U.S.C. 284m(c)) is amended— 
(1) in subsection (c)(1)— 
(A) in the matter preceding subparagraph 
(A), by inserting ‘‘or section 351(m) of this 
Act,’’ after ‘‘Cosmetic Act,’’; 
(B) in subparagraph (A)(i), by inserting 
‘‘or section 351(k) of this Act’’ after ‘‘Cosmetic 
Act’’; and 
(C) by amending subparagraph (B) to read 
as follows: 
‘‘(B)(i) there remains no patent listed pur-
suant to section 505(b)(1) of the Federal Food, 
Drug, and Cosmetic Act; and 
‘‘(ii) every three-year and five-year period 
referred 
to 
in 
subsection 
(c)(3)(E)(ii),
124 
(c)(3)(E)(iii), 
(c)(3)(E(iv), 
(j)(5)(F)(ii), 
(j)(5)(F)(iii), or (j)(5)(F)(iv) of section 505 of 
the Federal Food, Drug and Cosmetic Act, or 
applicable twelve-year period referred to in sec-
tion 351(k)(7) of this Act, and any seven-year 
period referred to in section 527 of the Federal 
Food, Drug, and Cosmetic Act, has ended for 
at least one form of the drug; and’’; 
(2) in subsection (c)(2)— 
(A) in the heading of paragraph (2), by 
striking ‘‘FOR DRUGS LACKING EXCLUSIVITY’’; 
(B) by striking ‘‘under section 505 of the 
Federal Food, Drug, and Cosmetic Act’’; and 
(C) by striking ‘‘505A of such Act’’ and 
inserting ‘‘505A of the Federal Food, Drug, 
and Cosmetic Act or section 351(m) of this 
Act’’; and 
(3) in subsection (e)(1), by striking ‘‘to carry 
out this section’’ and all that follows through the 
end of paragraph (1) and inserting ‘‘$25,000,000 
for each of fiscal years 2013 through 2017.’’. 
(b) PEDIATRIC STUDIES OF DRUGS IN FFDCA.— 
Section 505A (21 U.S.C. 355a) is amended— 
(1) in subsection (d)(1)(A), by adding at the 
end the following: ‘‘If a request under this subpara-
125 
graph does not request studies in neonates, such re-
quest shall include a statement describing the ra-
tionale for not requesting studies in neonates.’’; 
(2) by amending subsection (h) to read as fol-
lows: 
‘‘(h) RELATIONSHIP TO PEDIATRIC RESEARCH RE-
QUIREMENTS.—Exclusivity under this section shall only be 
granted for the completion of a study or studies that are 
the subject of a written request and for which reports are 
submitted and accepted in accordance with subsection 
(d)(3). Written requests under this section may consist of 
a study or studies required under section 505B.’’; 
(3) in subsection (k)(2), by striking ‘‘subsection 
(f)(3)(F)’’ and inserting ‘‘subsection (f)(6)(F)’’; 
(4) in subsection (l)— 
(A) in paragraph (1)— 
(i) in the paragraph heading, by strik-
ing ‘‘YEAR ONE’’ and inserting ‘‘FIRST 18- 
MONTH PERIOD’’; and 
(ii) by striking ‘‘one-year’’ and insert-
ing ‘‘18-month’’; 
(B) in paragraph (2)— 
(i) in the paragraph heading, by strik-
ing ‘‘YEARS’’ and inserting ‘‘PERIODS’’; 
and
126 
(ii) by striking ‘‘one-year period’’ and 
inserting ‘‘18-month period’’; 
(C) by redesignating paragraph (3) as 
paragraph (4); and 
(D) by inserting after paragraph (2) the 
following: 
‘‘(3) PRESERVATION OF AUTHORITY.—Nothing 
in this subsection shall prohibit the Office of Pedi-
atric Therapeutics from providing for the review of 
adverse event reports by the Pediatric Advisory 
Committee prior to the 18-month period referred to 
in paragraph (1), if such review is necessary to en-
sure safe use of a drug in a pediatric population.’’; 
(5) in subsection (n)— 
(A) in the subsection heading, by striking 
‘‘COMPLETED’’ and inserting ‘‘SUBMITTED’’; 
and 
(B) in paragraph (1)— 
(i) in the text preceding subparagraph 
(A), by striking ‘‘have not been completed’’ 
and inserting ‘‘have not been submitted by 
the date specified in the written request 
issued and agreed upon’’; and 
(ii) by revising subparagraphs (A) and 
(B) to read as follows:
127 
‘‘(A) For a drug for which there remains 
any listed patent or exclusivity protection eligi-
ble for extension under subsection (b)(1) or 
(c)(1) of this section, or any exclusivity protec-
tion eligible for extension under subsection 
(m)(2) or (m)(3) of section 351 of the Public 
Health Service Act, the Secretary shall make a 
determination regarding whether an assessment 
shall be required to be submitted under section 
505B(b). 
‘‘(B) For a drug that has no remaining 
listed patents or exclusivity protection eligible 
for extension under subsection (b)(1) or (c)(1) 
of this section, or any exclusivity protection eli-
gible for extension under subsection (m)(2) or 
(m)(3) of section 351 of the Public Health 
Service Act, the Secretary shall refer the drug 
for inclusion on the list established under sec-
tion 409I of the Public Health Service Act for 
the conduct of studies.’’; 
(6) in subsection (o)(2), by amending subpara-
graph (B) to read as follows: 
‘‘(B) a statement of any appropriate pedi-
atric contraindications, warnings, precautions,
128 
or other information that the Secretary con-
siders necessary to assure safe use.’’; and 
(7) by striking subsection (q) (relating to a sun-
set). 
(c) RESEARCH INTO PEDIATRIC USES FOR DRUGS 
AND BIOLOGICAL PROJECTS IN FFDCA.—Section 505B 
(21 U.S.C. 355c) is amended— 
(1) in subsection (a)— 
(A) in paragraph (1), in the matter before 
subparagraph (A), by inserting ‘‘for a drug’’ 
after ‘‘(or supplement to an application)’’; 
(B) in paragraph (3)— 
(i) by redesignating subparagraph (B) 
as subparagraph (D); and 
(ii) by inserting after subparagraph 
(A) the following: 
‘‘(B) DEFERRAL EXTENSION.—On the ini-
tiative of the Secretary or at the request of the 
applicant, the Secretary may grant an extension 
of a deferral under subparagraph (A) if— 
‘‘(i) the Secretary finds that the cri-
teria specified in subclause (II) or (III) of 
subparagraph (A)(i) continue to be met; 
and
129 
‘‘(ii) the applicant submits the mate-
rials required under subparagraph (A)(ii). 
‘‘(C) CONSIDERATION DURING DEFERRAL 
PERIOD.—If the Secretary has under this para-
graph deferred the date by which an assessment 
must be submitted, then until the date specified 
in the deferral under subparagraph (A) (includ-
ing any extension of such date under subpara-
graph (B))— 
‘‘(i) the assessment shall not be con-
sidered late or delayed; and 
‘‘(ii) the Secretary shall not classify 
the assessment as late or delayed in any 
report, database, or public posting.’’; and 
(iii) in subparagraph (D), as redesig-
nated, by amending clause (ii) to read as 
follows: 
‘‘(ii) 
PUBLIC
AVAILABILITY.—Not 
later than 60 days after the submission to 
the Secretary of the information submitted 
through the annual review under clause (i), 
the Secretary shall make available to the 
public in an easily accessible manner, in-
cluding through the Web site of the Food 
and Drug Administration—
130 
‘‘(I) such information; 
‘‘(II) the name of the applicant 
for the product subject to the assess-
ment; 
‘‘(III) the date on which the 
product was approved; and 
‘‘(IV) the date of each deferral or 
deferral extension under this para-
graph for the product.’’; and 
(C) in paragraph (4)(C)— 
(i) in the first sentence, by inserting 
‘‘partial’’ before ‘‘waiver is granted’’; and 
(ii) in the second sentence, by striking 
‘‘either a full or partial waiver’’ and insert-
ing ‘‘a partial waiver’’; 
(2) in subsection (b)(1), by striking ‘‘After pro-
viding notice in the form of a letter (that, for a drug 
approved under section 505, references a declined 
written request under section 505A for a labeled in-
dication which written request is not referred under 
section 505A(n)(1)(A) to the Foundation of the Na-
tional Institutes of Health for the pediatric studies), 
the Secretary’’ and inserting ‘‘The Secretary’’; 
(3) by amending subsection (d) to read as fol-
lows:
131 
‘‘(d) FAILURE TO MEET REQUIREMENTS.—If a per-
son fails to submit a required assessment described in sub-
section (a)(2), fails to meet the applicable requirements 
in subsection (a)(3), or fails to submit a request for ap-
proval of a pediatric formulation described in subsection 
(a) or (b), in accordance with applicable provisions of sub-
sections (a) and (b)— 
‘‘(1)(A) the Secretary shall issue a letter to 
such person informing such person of such failure; 
‘‘(B) not later than 30 calendar days after the 
issuance of a letter under subparagraph (A), the 
person who receives such letter shall submit to the 
Secretary a written response to such letter; and 
‘‘(C) not later than 45 calendar days after the 
issuance of a letter under subparagraph (A), the 
Secretary shall make such letter, and any response 
to such letter under subparagraph (B), available to 
the public on the Web site of the Food and Drug 
Administration, with appropriate redactions made to 
protect trade secrets and confidential commercial in-
formation, except that, if the Secretary determines 
that the letter under subparagraph (A) was issued 
in error, the requirements of this subparagraph shall 
not apply with respect to such letter; and
136 
ment in the same manner and to the same ex-
tent as such requirements apply to an initial pe-
diatric plan under paragraph (1). The require-
ments of subparagraphs (A) through (C) of this 
paragraph shall apply to any agreement result-
ing from such proposed amendment in the same 
manner and to the same extent as such require-
ments apply to an agreed initial pediatric plan. 
‘‘(4) INTERNAL
COMMITTEE.—The Secretary 
shall consult the internal committee under section 
505C on the review of the initial pediatric plan, 
greed initial pediatric plan, and any amendments to 
such plans. 
‘‘(5) MANDATORY
RULEMAKING.—Not later 
than one year after the date of enactment of the 
Food and Drug Administration Reform Act of 2012, 
the Secretary shall promulgate proposed regulations 
and guidance to implement the provisions of this 
subsection. 
‘‘(6) EFFECTIVE DATE.—The provisions of this 
subsection shall take effect 180 calendar days after 
the date of enactment of the Food and Drug Admin-
istration Reform Act of 2012, irrespective of wheth-
er the Secretary has promulgated final regulations 
to carry out this subsection by such date.’’;
169 
‘‘(iii) Upon receipt of a request under clause (i) or 
(ii), the Secretary shall classify the device subject to the 
request under the criteria set forth in subparagraphs (A) 
through (C) of subsection (a)(1) within 120 days. 
‘‘(iv) Notwithstanding clause (iii), the Secretary may 
decline to undertake a classification of a device pursuant 
to a request under clause (ii) if the Secretary— 
‘‘(I) identifies a legally marketed device that 
would permit a substantial equivalence determina-
tion under paragraph (1) for the device; or 
‘‘(II) determines that the device submitted is 
not of low-moderate risk or special controls to miti-
gate the risks cannot be developed for the device. 
‘‘(v) The person submitting the request for classifica-
tion under this subparagraph may recommend to the Sec-
retary a classification for the device and shall, if recom-
mending classification in class II, include in the request 
an initial draft proposal for applicable special controls, as 
described in subsection (a)(1)(B), that are necessary, in 
conjunction with general controls, to provide reasonable 
assurance of safety and effectiveness and a description of 
how the special controls provide such assurance. Any such 
request shall describe the device and provide detailed in-
formation and reasons for the recommended classifica-
tion.’’; and