I 
113TH CONGRESS 
1ST SESSION H. R. 1407 
To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user 
fee programs relating to new animal drugs. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 9, 2013 
Mr. SHIMKUS (for himself, Mr. GARDNER, Mr. UPTON, Mr. PITTS, Mr. WAX-
MAN, Mr. PALLONE, Mr. BURGESS, Mr. GUTHRIE, and Mr. KINZINGER 
of Illinois) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
reauthorize user fee programs relating to new animal drugs. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; FINDING. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Animal Drug User Fee Amendments of 2013’’. 
(b) FINDING.—Congress finds that the fees author-
ized by the amendments made in this Act will be dedicated 
toward expediting the animal drug development process 
and the review of new and supplemental animal drug ap-
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‘‘(B) a request to the Secretary to approve 
a change to an application approved under sec-
tion 512(c)(2) for which data with respect to 
safety or effectiveness are required. 
‘‘(3) The term ‘animal drug product’ means 
each specific strength or potency of a particular ac-
tive ingredient or ingredients in final dosage form 
marketed by a particular manufacturer or dis-
tributor, which is uniquely identified by the labeler 
code and product code portions of the national drug 
code, and for which an animal drug application or 
a supplemental animal drug application has been ap-
proved. 
‘‘(4) The term ‘animal drug establishment’ 
means a foreign or domestic place of business which 
is at one general physical location consisting of one 
or more buildings all of which are within 5 miles of 
each other, at which one or more animal drug prod-
ucts are manufactured in final dosage form. 
‘‘(5) The term ‘investigational animal drug sub-
mission’ means— 
‘‘(A) the filing of a claim for an investiga-
tional exemption under section 512(j) for a new 
animal drug intended to be the subject of an 
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animal drug application or a supplemental ani-
mal drug application; or 
‘‘(B) the submission of information for the 
purpose of enabling the Secretary to evaluate 
the safety or effectiveness of an animal drug 
application or supplemental animal drug appli-
cation in the event of their filing. 
‘‘(6) The term ‘animal drug sponsor’ means ei-
ther an applicant named in an animal drug applica-
tion that has not been withdrawn by the applicant 
and for which approval has not been withdrawn by 
the Secretary, or a person who has submitted an in-
vestigational animal drug submission that has not 
been terminated or otherwise rendered inactive by 
the Secretary. 
‘‘(7) The term ‘final dosage form’ means, with 
respect to an animal drug product, a finished dosage 
form which is approved for administration to an ani-
mal without substantial further manufacturing. Such 
term includes animal drug products intended for 
mixing in animal feeds. 
‘‘(8) The term ‘process for the review of animal 
drug applications’ means the following activities of 
the Secretary with respect to the review of animal 
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drug applications, supplemental animal drug applica-
tions, and investigational animal drug submissions: 
‘‘(A) The activities necessary for the re-
view of animal drug applications, supplemental 
animal drug applications, and investigational 
animal drug submissions. 
‘‘(B) The issuance of action letters which 
approve animal drug applications or supple-
mental animal drug applications or which set 
forth in detail the specific deficiencies in animal 
drug applications, supplemental animal drug 
applications, or investigational animal drug sub-
missions and, where appropriate, the actions 
necessary to place such applications, supple-
ments, or submissions in condition for approval. 
‘‘(C) The inspection of animal drug estab-
lishments and other facilities undertaken as 
part of the Secretary’s review of pending animal 
drug applications, supplemental animal drug 
applications, and investigational animal drug 
submissions. 
‘‘(D) Monitoring of research conducted in 
connection with the review of animal drug ap-
plications, supplemental animal drug applica-
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tions, and investigational animal drug submis-
sions. 
‘‘(E) The development of regulations and 
policy related to the review of animal drug ap-
plications, supplemental animal drug applica-
tions, and investigational animal drug submis-
sions. 
‘‘(F) Development of standards for prod-
ucts subject to review. 
‘‘(G) Meetings between the agency and the 
animal drug sponsor. 
‘‘(H) Review of advertising and labeling 
prior to approval of an animal drug application 
or supplemental animal drug application, but 
not after such application has been approved. 
‘‘(9) The term ‘costs of resources allocated for 
the process for the review of animal drug applica-
tions’ means the expenses in connection with the 
process for the review of animal drug applications 
for— 
‘‘(A) officers and employees of the Food 
and Drug Administration, contractors of the 
Food and Drug Administration, advisory com-
mittees consulted with respect to the review of 
specific animal drug applications, supplemental 
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animal drug applications, or investigational ani-
mal drug submissions, and costs related to such 
officers, employees, committees, and contrac-
tors, including costs for travel, education, and 
recruitment and other personnel activities; 
‘‘(B) management of information and the 
acquisition, maintenance, and repair of com-
puter resources; 
‘‘(C) leasing, maintenance, renovation, and 
repair of facilities and acquisition, maintenance, 
and repair of fixtures, furniture, scientific 
equipment, and other necessary materials and 
supplies; and 
‘‘(D) collecting fees under section 740 and 
accounting for resources allocated for the re-
view of animal drug applications, supplemental 
animal drug applications, and investigational 
animal drug submissions. 
‘‘(10) The term ‘adjustment factor’ applicable 
to a fiscal year refers to the formula set forth in sec-
tion 735(8) with the base or comparator month 
being October 2002. 
‘‘(11) The term ‘person’ includes an affiliate 
thereof. 
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‘‘(12) The term ‘affiliate’ refers to the defini-
tion set forth in section 735(11).’’. 
SEC. 3. AUTHORITY TO ASSESS AND USE ANIMAL DRUG 
FEES. 
Section 740 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–12) is amended to read as follows: 
‘‘SEC. 740. AUTHORITY TO ASSESS AND USE ANIMAL DRUG 
FEES. 
‘‘(a) TYPES
OF FEES.—Beginning in fiscal year 
2004, the Secretary shall assess and collect fees in accord-
ance with this section as follows: 
‘‘(1) ANIMAL DRUG APPLICATION AND SUPPLE-
MENT FEE.— 
‘‘(A) IN GENERAL.—Each person that sub-
mits, on or after September 1, 2003, an animal 
drug application or a supplemental animal drug 
application shall be subject to a fee as follows: 
‘‘(i) A fee established in subsection (c) 
for an animal drug application, except an 
animal drug application described in sec-
tion 512(d)(4). 
‘‘(ii) A fee established in subsection 
(c), in an amount that is equal to 50 per-
cent of the amount of the fee under clause 
(i), for— 
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‘‘(I) a supplemental animal drug 
application for which safety or effec-
tiveness data are required; and 
‘‘(II) an animal drug application 
described in section 512(d)(4). 
‘‘(B) PAYMENT.—The fee required by sub-
paragraph (A) shall be due upon submission of 
the animal drug application or supplemental 
animal drug application. 
‘‘(C) EXCEPTION FOR PREVIOUSLY FILED 
APPLICATION OR SUPPLEMENT.—If an animal 
drug application or a supplemental animal drug 
application was submitted by a person that paid 
the fee for such application or supplement, was 
accepted for filing, and was not approved or 
was withdrawn (without a waiver or refund), 
the submission of an animal drug application or 
a supplemental animal drug application for the 
same product by the same person (or the per-
son’s licensee, assignee, or successor) shall not 
be subject to a fee under subparagraph (A). 
‘‘(D) REFUND OF FEE IF APPLICATION RE-
FUSED FOR FILING.—The Secretary shall re-
fund 75 percent of the fee paid under subpara-
graph (B) for any animal drug application or 
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mal drug application or supplemental ani-
mal drug application, 
shall pay for each such animal drug product the 
annual fee established in subsection (c). 
‘‘(B) PAYMENT; FEE DUE DATE.—Such fee 
shall be payable for the fiscal year in which the 
animal drug product is first submitted for list-
ing under section 510, or is submitted for re-
listing under section 510 if the animal drug 
product has been withdrawn from listing and 
relisted. After such fee is paid for that fiscal 
year, such fee shall be due each subsequent fis-
cal year that the product remains listed, upon 
the later of— 
‘‘(i) the first business day after the 
date of enactment of an appropriations Act 
providing for the collection and obligation 
of fees for such fiscal year under this sec-
tion; or 
‘‘(ii) January 31 of each year. 
‘‘(C) LIMITATION.—Such fee shall be paid 
only once for each animal drug product for a 
fiscal year in which the fee is payable. 
‘‘(3) ANIMAL DRUG ESTABLISHMENT FEE.— 
‘‘(A) IN GENERAL.—Each person— 
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‘‘(i) who owns or operates, directly or 
through an affiliate, an animal drug estab-
lishment; 
‘‘(ii) who is named as the applicant in 
an animal drug application or supple-
mental animal drug application for an ani-
mal drug product which has been sub-
mitted for listing under section 510; and 
‘‘(iii) who, after September 1, 2003, 
had pending before the Secretary an ani-
mal drug application or supplemental ani-
mal drug application, 
shall be assessed an annual establishment fee as 
established in subsection (c) for each animal 
drug establishment listed in its approved animal 
drug application as an establishment that man-
ufactures the animal drug product named in the 
application. 
‘‘(B) PAYMENT; FEE DUE DATE.—The an-
nual establishment fee shall be assessed in each 
fiscal year in which the animal drug product 
named in the application is assessed a fee under 
paragraph (2) unless the animal drug establish-
ment listed in the application does not engage 
in the manufacture of the animal drug product 
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during the fiscal year. The fee under this para-
graph for a fiscal year shall be due upon the 
later of— 
‘‘(i) the first business day after the 
date of enactment of an appropriations Act 
providing for the collection and obligation 
of fees for such fiscal year under this sec-
tion; or 
‘‘(ii) January 31 of each year. 
‘‘(C) LIMITATION.— 
‘‘(i) IN GENERAL.—An establishment 
shall be assessed only one fee per fiscal 
year under this section, subject to clause 
(ii). 
‘‘(ii) CERTAIN
MANUFACTURERS.—If 
a single establishment manufactures both 
animal drug products and prescription 
drug products, as defined in section 
735(3), such establishment shall be as-
sessed both the animal drug establishment 
fee and the prescription drug establish-
ment fee, as set forth in section 736(a)(2), 
within a single fiscal year. 
‘‘(4) ANIMAL DRUG SPONSOR FEE.— 
‘‘(A) IN GENERAL.—Each person— 
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‘‘(i) who meets the definition of an 
animal drug sponsor within a fiscal year; 
and 
‘‘(ii) who, after September 1, 2003, 
had pending before the Secretary an ani-
mal drug application, a supplemental ani-
mal drug application, or an investigational 
animal drug submission, 
shall be assessed an annual sponsor fee as es-
tablished under subsection (c). 
‘‘(B) PAYMENT; FEE DUE DATE.—The fee 
under this paragraph for a fiscal year shall be 
due upon the later of— 
‘‘(i) the first business day after the 
date of enactment of an appropriations Act 
providing for the collection and obligation 
of fees for such fiscal year under this sec-
tion; or 
‘‘(ii) January 31 of each year. 
‘‘(C) LIMITATION.—Each animal drug 
sponsor shall pay only one such fee each fiscal 
year. 
‘‘(b) FEE REVENUE AMOUNTS.— 
‘‘(1) IN GENERAL.—Subject to subsections (c), 
(d), (f), and (g)— 
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‘‘(A) for fiscal year 2014, the fees required 
under subsection (a) shall be established to gen-
erate a total revenue amount of $23,600,000; 
and 
‘‘(B) for each of fiscal years 2015 through 
2018, the fees required under subsection (a) 
shall be established to generate a total revenue 
amount of $21,600,000. 
‘‘(2) TYPES
OF
FEES.—Of the total revenue 
amount determined for a fiscal year under para-
graph (1)— 
‘‘(A) 20 percent shall be derived from fees 
under subsection (a)(1) (relating to animal 
drug applications and supplements); 
‘‘(B) 27 percent shall be derived from fees 
under subsection (a)(2) (relating to animal 
drug products); 
‘‘(C) 26 percent shall be derived from fees 
under subsection (a)(3) (relating to animal 
drug establishments); and 
‘‘(D) 27 percent shall be derived from fees 
under subsection (a)(4) (relating to animal 
drug sponsors). 
‘‘(c) ANNUAL FEE SETTING; ADJUSTMENTS.— 
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‘‘(1) ANNUAL
FEE
SETTING.—The Secretary 
shall establish, 60 days before the start of each fis-
cal year beginning after September 30, 2003, for 
that fiscal year, animal drug application fees, sup-
plemental animal drug application fees, animal drug 
sponsor fees, animal drug establishment fees, and 
animal drug product fees based on the revenue 
amounts established under subsection (b) and the 
adjustments provided under this subsection. 
‘‘(2) INFLATION ADJUSTMENT.—For fiscal year 
2015 and subsequent fiscal years, the revenue 
amounts established in subsection (b) shall be ad-
justed by the Secretary by notice, published in the 
Federal Register, 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 of the preceding 
4 fiscal years for which data are available, mul-
tiplied by the average proportion of personnel 
compensation and benefits costs to total Food 
and Drug Administration costs for the first 3 
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years of the preceding 4 fiscal years for which 
data are available; 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 
less food and energy; annual index) for the first 
3 years of the preceding 4 years for which data 
are available multiplied by the average propor-
tion of all costs other than personnel compensa-
tion and benefits costs to total Food and Drug 
Administration costs for the first 3 years of the 
preceding 4 fiscal years for which data are 
available. 
The adjustment made each fiscal year under this 
paragraph shall be added on a compounded basis to 
the sum of all adjustments made each fiscal year 
after fiscal year 2014 under this paragraph. 
‘‘(3) WORKLOAD
ADJUSTMENT.—For fiscal 
year 2015 and subsequent fiscal years, after the rev-
enue amounts established in subsection (b) are ad-
justed for inflation in accordance with paragraph 
(2), the revenue amounts shall be further adjusted 
for such fiscal year to reflect changes in the work-
load of the Secretary for the process for the review 
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of animal drug applications. With respect to such 
adjustment— 
‘‘(A) such adjustment shall be determined 
by the Secretary based on a weighted average 
of the change in the total number of animal 
drug applications, supplemental animal drug 
applications for which data with respect to safe-
ty or effectiveness are required, manufacturing 
supplemental animal drug applications, inves-
tigational animal drug study submissions, and 
investigational animal drug protocol submis-
sions submitted to the Secretary; 
‘‘(B) the Secretary shall publish in the 
Federal Register the fees resulting from such 
adjustment and the supporting methodologies; 
and 
‘‘(C) under no circumstances shall such ad-
justment result in fee revenues for a fiscal year 
that are less than the fee revenues for that fis-
cal year established in subsection (b), as ad-
justed for inflation under paragraph (2). 
‘‘(4) FINAL
YEAR
ADJUSTMENT.—For fiscal 
year 2018, the Secretary may, in addition to other 
adjustments under this subsection, further increase 
the fees under this section, if such an adjustment is 
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necessary to provide for up to 3 months of operating 
reserves of carryover user fees for the process for 
the review of animal drug applications for the first 
3 months of fiscal year 2019. If the Food and Drug 
Administration has carryover balances for the proc-
ess for the review of animal drug applications in ex-
cess of 3 months of such operating reserves, then 
this adjustment will not be made. If this adjustment 
is necessary, then the rationale for the amount of 
the increase shall be contained in the annual notice 
setting fees for fiscal year 2018. 
‘‘(5) LIMIT.—The total amount of fees charged, 
as adjusted under this subsection, for a fiscal year 
may not exceed the total costs for such fiscal year 
for the resources allocated for the process for the re-
view of animal drug applications. 
‘‘(d) FEE WAIVER OR REDUCTION.— 
‘‘(1) IN GENERAL.—The Secretary shall grant a 
waiver from or a reduction of one or more fees as-
sessed under subsection (a) where the Secretary 
finds that— 
‘‘(A) the assessment of the fee would 
present a significant barrier to innovation be-
cause of limited resources available to such per-
son or other circumstances; 
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‘‘(B) the fees to be paid by such person 
will exceed the anticipated present and future 
costs incurred by the Secretary in conducting 
the process for the review of animal drug appli-
cations for such person; 
‘‘(C) the animal drug application or sup-
plemental animal drug application is intended 
solely to provide for use of the animal drug 
in— 
‘‘(i) a Type B medicated feed (as de-
fined in section 558.3(b)(3) of title 21, 
Code of Federal Regulations (or any suc-
cessor regulation)) intended for use in the 
manufacture of Type C free-choice medi-
cated feeds; or 
‘‘(ii) a Type C free-choice medicated 
feed (as defined in section 558.3(b)(4) of 
title 21, Code of Federal Regulations (or 
any successor regulation)); 
‘‘(D) the animal drug application or sup-
plemental animal drug application is intended 
solely to provide for a minor use or minor spe-
cies indication; or 
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‘‘(E) the sponsor involved is a small busi-
ness submitting its first animal drug applica-
tion to the Secretary for review. 
‘‘(2) USE OF STANDARD COSTS.—In making the 
finding in paragraph (1)(B), the Secretary may use 
standard costs. 
‘‘(3) RULES FOR SMALL BUSINESSES.— 
‘‘(A) DEFINITION.—In paragraph (1)(E), 
the term ‘small business’ means an entity that 
has fewer than 500 employees, including em-
ployees of affiliates. 
‘‘(B) WAIVER OF APPLICATION FEE.—The 
Secretary shall waive under paragraph (1)(E) 
the application fee for the first animal drug ap-
plication that a small business or its affiliate 
submits to the Secretary for review. After a 
small business or its affiliate is granted such a 
waiver, the small business or its affiliate shall 
pay application fees for all subsequent animal 
drug applications and supplemental animal 
drug applications for which safety or effective-
ness data are required in the same manner as 
an entity that does not qualify as a small busi-
ness. 
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‘‘(C) CERTIFICATION.—The Secretary shall 
require any person who applies for a waiver 
under paragraph (1)(E) to certify their quali-
fication for the waiver. The Secretary shall peri-
odically publish in the Federal Register a list of 
persons making such certifications. 
‘‘(e) EFFECT OF FAILURE TO PAY FEES.—An ani-
mal drug application or supplemental animal drug applica-
tion submitted by a person subject to fees under sub-
section (a) shall be considered incomplete and shall not 
be accepted for filing by the Secretary until all fees owed 
by such person have been paid. An investigational animal 
drug submission under section 739(5)(B) that is sub-
mitted by a person subject to fees under subsection (a) 
shall be considered incomplete and shall not be accepted 
for review by the Secretary until all fees owed by such 
person have been paid. The Secretary may discontinue re-
view of any animal drug application, supplemental animal 
drug application, or investigational animal drug submis-
sion from a person if such person has not submitted for 
payment all fees owed under this section by 30 days after 
the date upon which they are due. 
‘‘(f) ASSESSMENT OF FEES.— 
‘‘(1) LIMITATION.—Fees may not be assessed 
under subsection (a) for a fiscal year beginning after 
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fiscal year 2003 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 2003 (excluding the 
amount of fees appropriated for such fiscal year) 
multiplied by the adjustment factor 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 because of paragraph (1) and if at 
a later date in such fiscal year the Secretary may as-
sess such fees, the Secretary may assess and collect 
such fees, without any modification in the rate, for 
animal drug applications, supplemental animal drug 
applications, investigational animal drug submis-
sions, animal drug sponsors, animal drug establish-
ments, and animal drug products at any time in 
such fiscal year notwithstanding the provisions of 
subsection (a) relating to the date fees are to be 
paid. 
‘‘(g) CREDITING AND AVAILABILITY OF FEES.— 
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‘‘(1) IN
GENERAL.—Subject to paragraph 
(2)(C), fees authorized under subsection (a) shall be 
collected and available for obligation only to the ex-
tent and in the amount provided in advance in ap-
propriations Acts. Such fees are authorized to be ap-
propriated to remain available until expended. Such 
sums as may be necessary may be transferred from 
the Food and Drug Administration salaries and ex-
penses appropriation account without fiscal year lim-
itation to such appropriation account for salary and 
expenses with such fiscal year limitation. The sums 
transferred shall be available solely for the process 
for the review of animal drug applications. 
‘‘(2) 
COLLECTIONS
AND
APPROPRIATION 
ACTS.— 
‘‘(A) IN
GENERAL.—The fees authorized 
by this section— 
‘‘(i) subject to subparagraph (C), 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 to defray in-
creases in the costs of the resources allo-
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cated for the process for the review of ani-
mal drug applications (including increases 
in such costs for an additional number of 
full-time equivalent positions in the De-
partment of Health and Human Services 
to be engaged in such process) over such 
costs, excluding costs paid from fees col-
lected under this section, for fiscal year 
2003 multiplied by the adjustment factor. 
‘‘(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 
the process for the review of animal drug appli-
cations— 
‘‘(i) are not more than 3 percent 
below the level specified in subparagraph 
(A)(ii); or 
‘‘(ii)(I) are more than 3 percent below 
the level specified in subparagraph (A)(ii), 
and fees assessed for the fiscal year fol-
lowing the subsequent fiscal year are de-
creased by the amount in excess of 3 per-
cent by which such costs fell below the 
level specified in subparagraph (A)(ii); and 
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‘‘(II) such costs are not more than 5 
percent below the level specified in sub-
paragraph (A)(ii). 
‘‘(C) PROVISION FOR EARLY PAYMENTS.— 
Payment of fees authorized under this section 
for a fiscal year, 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 2014 through 2018, 
there is authorized to be appropriated for fees under 
this section an amount equal to the total revenue 
amount determined under subsection (b) for the fis-
cal year, as adjusted or otherwise affected under 
subsection (c) and paragraph (4). 
‘‘(4) OFFSET OF OVERCOLLECTIONS; RECOVERY 
OF COLLECTION SHORTFALLS.— 
‘‘(A) OFFSET
OF
OVERCOLLECTIONS.—If 
the sum of the cumulative amount of fees col-
lected under this section for fiscal years 2014 
through 2016 and the amount of fees estimated 
to be collected under this section for fiscal year 
2017 (including any increased fee collections at-
tributable to subparagraph (B)), exceeds the 
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cumulative amount appropriated pursuant to 
paragraph (3) for the fiscal years 2014 through 
2017, the excess amount shall be credited to 
the appropriation account of the Food and 
Drug Administration as provided in paragraph 
(1), and shall be subtracted from the amount of 
fees that would otherwise be authorized to be 
collected under this section pursuant to appro-
priation Acts for fiscal year 2018. 
‘‘(B) RECOVERY OF COLLECTION SHORT-
FALLS.— 
‘‘(i) FISCAL
YEAR
2016.—For fiscal 
year 2016, the amount of fees otherwise 
authorized to be collected under this sec-
tion shall be increased by the amount, if 
any, by which the amount collected under 
this section and appropriated for fiscal 
year 2014 falls below the amount of fees 
authorized for fiscal year 2014 under para-
graph (3). 
‘‘(ii) FISCAL
YEAR
2017.—For fiscal 
year 2017, the amount of fees otherwise 
authorized to be collected under this sec-
tion shall be increased by the amount, if 
any, by which the amount collected under 
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this section and appropriated for fiscal 
year 2015 falls below the amount of fees 
authorized for fiscal year 2015 under para-
graph (3). 
‘‘(iii) FISCAL YEAR 2018.—For fiscal 
year 2018, the amount of fees otherwise 
authorized to be collected under this sec-
tion (including any reduction in the au-
thorized amount under subparagraph (A)), 
shall be increased by the cumulative 
amount, if any, by which the amount col-
lected under this section and appropriated 
for fiscal years 2016 and 2017 (including 
estimated collections for fiscal year 2017) 
falls below the cumulative amount of fees 
authorized under paragraph (3) for fiscal 
years 2016 and 2017. 
‘‘(h) 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. 
‘‘(i) WRITTEN REQUESTS
FOR WAIVERS, REDUC-
TIONS, AND REFUNDS.—To qualify for consideration for 
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a waiver or reduction under subsection (d), or for a refund 
of any fee collected in accordance with subsection (a), a 
person shall submit to the Secretary a written request for 
such waiver, reduction, or refund not later than 180 days 
after such fee is due. 
‘‘(j) 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 the process of the review of animal drug appli-
cations, be reduced to offset the number of officers, em-
ployees, and advisory committees so engaged. 
‘‘(k) ABBREVIATED NEW ANIMAL DRUG APPLICA-
TIONS.—The Secretary shall— 
‘‘(1) to the extent practicable, segregate the re-
view of abbreviated new animal drug applications 
from the process for the review of animal drug appli-
cations; and 
‘‘(2) adopt other administrative procedures to 
ensure that review times of abbreviated new animal 
drug applications do not increase from their current 
level due to activities under the user fee program.’’. 
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SEC. 4. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 740A of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379j–13) is amended to read as fol-
lows: 
‘‘SEC. 740A. REAUTHORIZATION; REPORTING REQUIRE-
MENTS. 
‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal 
year 2014, not later than 120 days after the end of each 
fiscal year during 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 1(b) of 
the Animal Drug User Fee Amendments of 2013 toward 
expediting the animal drug development process and the 
review of the new and supplemental animal drug applica-
tions and investigational animal drug submissions during 
such fiscal year, the future plans of the Food and Drug 
Administration for meeting the goals, the review times for 
abbreviated new animal drug applications, and the admin-
istrative procedures adopted by the Food and Drug Ad-
ministration to ensure that review times for abbreviated 
new animal drug applications are not increased from their 
current level due to activities under the user fee program. 
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‘‘(b) FISCAL REPORT.—Beginning with fiscal year 
2014, not later than 120 days after the end of each fiscal 
year during 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 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 during such fiscal year for which the report is 
made. 
‘‘(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 the process for the review of animal drug appli-
cations for the first 5 fiscal years after fiscal year 
2018, 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; 
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‘‘(B) the Committee on Health, Education, 
Labor, and Pensions of the Senate; 
‘‘(C) scientific and academic experts; 
‘‘(D) veterinary professionals; 
‘‘(E) representatives of patient and con-
sumer advocacy groups; and 
‘‘(F) the regulated industry. 
‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning 
negotiations with the regulated industry on the reau-
thorization 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 4 months during negotia-
tions with the regulated industry, the Secretary shall 
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hold discussions with representatives of veterinary, 
patient, and consumer advocacy groups to continue 
discussions of their views on the reauthorization and 
their suggestions for changes to this part as ex-
pressed under paragraph (2). 
‘‘(4) 
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. 
‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.— 
Not later than January 15, 2018, the Secretary 
shall transmit to Congress the revised recommenda-
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tions under paragraph (4), a summary of the views 
and comments received under such paragraph, and 
any changes made to the recommendations in re-
sponse 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 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 reg-
ulated 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. 5. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this Act, 
part 4 of subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as 
in effect on the day before the date of the enactment of 
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this Act, shall continue to be in effect with respect to ani-
mal drug applications and supplemental animal drug ap-
plications (as defined in such part as of such day) that 
on or after October 1, 2008, but before October 1, 2013, 
were accepted by the Food and Drug Administration for 
filing with respect to assessing and collecting any fee re-
quired by such part for a fiscal year prior to fiscal year 
2014. 
SEC. 6. EFFECTIVE DATE. 
The amendments made by this Act shall take effect 
on October 1, 2013, or the date of enactment of this Act, 
whichever is later, except that fees under part 4 of sub-
chapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act, as amended by this Act, shall be assessed 
for all animal drug applications and supplemental animal 
drug applications received on or after October 1, 2013, 
regardless of the date of the enactment of this Act. 
SEC. 7. SUNSET DATES. 
(a) AUTHORIZATION.—Section 740 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12) shall 
cease to be effective October 1, 2018. 
(b) REPORTING REQUIREMENTS.—Section 740A of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j–13) shall cease to be effective January 31, 2019. 
(c) PREVIOUS SUNSET PROVISION.— 
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(1) IN GENERAL.—Section 108 of the Animal 
Drug User Fee Amendments of 2008 (Public Law 
110–316) is repealed. 
(2) CONFORMING
AMENDMENT.—The Animal 
Drug User Fee Amendments of 2008 (Public Law 
110–316) is amended in the table of contents in sec-
tion 1, by striking the item relating to section 108. 
(d) TECHNICAL CLARIFICATION.—Effective Novem-
ber 18, 2003, section 5 of the Animal Drug User Fee Act 
of 2003 (Public Law 108–130) is repealed. 
Æ 
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