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 
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‘‘(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-
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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. 
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‘‘(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 
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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 
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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. 
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