in the meaning of section 505(j)(5)(A) for a 
cause other than failure to pay fees. 
‘‘(E) FEE FOR AN APPLICATION THE SEC-
RETARY CONSIDERS NOT TO HAVE BEEN RE-
CEIVED, OR THAT HAS BEEN WITHDRAWN.—An 
abbreviated new drug application or prior ap-
proval supplement that was submitted on or 
after October 1, 2012, and that the Secretary 
considers not to have been received, or that has 
been withdrawn, shall, upon resubmission of the 
application or a subsequent new submission fol-
lowing the applicant’s withdrawal of the appli-
cation, be subject to a full fee under subpara-
graph (A). 
‘‘(F) ADDITIONAL FEE FOR ACTIVE PHAR-
MACEUTICAL
INGREDIENT
INFORMATION
NOT 
INCLUDED BY REFERENCE TO TYPE II ACTIVE 
PHARMACEUTICAL INGREDIENT DRUG MASTER 
FILE.—An applicant that submits a generic 
drug submission on or after October 1, 2012, 
shall pay a fee, in the amount determined under 
subsection (d)(3), in addition to the fee re-
quired under subparagraph (A), if— 
‘‘(i) such submission contains infor-
mation concerning the manufacture of an
active pharmaceutical ingredient at a facil-
ity by means other than reference by a let-
ter of authorization to a Type II active 
pharmaceutical drug master file; and 
‘‘(ii) a fee in the amount equal to the 
drug master file fee established in para-
graph (2) has not been previously paid 
with respect to such information. 
‘‘(4) GENERIC DRUG FACILITY FEE AND ACTIVE 
PHARMACEUTICAL INGREDIENT FACILITY FEE.— 
‘‘(A) IN
GENERAL.—Facilities identified, 
or intended to be identified, in at least one ge-
neric drug submission that is pending or ap-
proved to produce a finished dosage form of a 
human generic drug or an active pharma-
ceutical ingredient contained in a human ge-
neric drug shall be subject to fees as follows: 
‘‘(i) GENERIC DRUG FACILITY.—Each 
person that owns a facility which is identi-
fied or intended to be identified in at least 
one generic drug submission that is pend-
ing or approved to produce one or more 
finished dosage forms of a human generic 
drug shall be assessed an annual fee for 
each such facility.
‘‘(ii) ACTIVE
PHARMACEUTICAL
IN-
GREDIENT
FACILITY.—Each person that 
owns a facility which produces, or which is 
pending review to produce, one or more ac-
tive pharmaceutical ingredients identified, 
or intended to be identified, in at least one 
generic drug submission that is pending or 
approved or in a Type II active pharma-
ceutical ingredient drug master file ref-
erenced in such a generic drug submission, 
shall be assessed an annual fee for each 
such facility. 
‘‘(iii) FACILITIES
PRODUCING
BOTH 
ACTIVE
PHARMACEUTICAL
INGREDIENTS 
AND
FINISHED
DOSAGE
FORMS.—Each 
person that owns a facility identified, or 
intended to be identified, in at least one 
generic drug submission that is pending or 
approved to produce both one or more fin-
ished dosage forms subject to clause (i) 
and one or more active pharmaceutical in-
gredients subject to clause (ii) shall be 
subject to fees under both such clauses for 
that facility.
‘‘(B) AMOUNT.—The amount of fees estab-
lished under subparagraph (A) shall be estab-
lished under subsection (d). 
‘‘(C) NOTICE.— 
‘‘(i) FISCAL
YEAR
2013.—For fiscal 
year 2013, the Secretary shall cause to be 
published in the Federal Register a notice 
announcing the amount of the fees pro-
vided for in subparagraph (A) within the 
timeframe 
specified 
in 
subsection 
(d)(1)(B). 
‘‘(ii) FISCAL
YEARS
2014
THROUGH 
2017.—Within the timeframe specified in 
subsection (d)(2), the Secretary shall cause 
to be published in the Federal Register the 
amount of the fees under subparagraph 
(A) for such fiscal year. 
‘‘(D) FEE DUE DATE.— 
‘‘(i) FISCAL
YEAR
2013.—For fiscal 
year 2013, the fees under subparagraph 
(A) shall be due on the later of— 
‘‘(I) not later than 45 days after 
the publication of the notice under 
subparagraph (B); or
‘‘(II) if an appropriations Act is 
not enacted providing for the collec-
tion and obligation of fees under this 
section by the date of the publication 
of such notice, 30 days after the date 
that such an appropriations Act is en-
acted. 
‘‘(ii) FISCAL
YEARS
2014
THROUGH 
2017.—For each of fiscal years 2014 
through 2017, the fees under subpara-
graph (A) for such 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 providing for the collection and 
obligation of fees under this section 
for such year. 
‘‘(5) DATE OF SUBMISSION.—For purposes of 
this part, a generic drug submission or Type II 
pharmaceutical master file is deemed to be ‘sub-
mitted’ to the Food and Drug Administration— 
‘‘(A) if it is submitted via a Food and 
Drug Administration electronic gateway, on the