IB 
Union Calendar No. 135 
113TH CONGRESS 
1ST SESSION H. R. 1407 
[Report No. 113–188] 
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 
AUGUST 2, 2013 
Reported with amendments, committed to the Committee of the Whole House 
on the State of the Union, and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on April 9, 2013] 
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A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
reauthorize user fee programs relating to new animal drugs. 
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Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. TABLE OF CONTENTS. 
Sec. 1. Table of Contents. 
TITLE I—ANIMAL DRUG USER FEE AMENDMENTS 
Sec. 101. Short title; finding. 
Sec. 102. Definitions. 
Sec. 103. Authority to assess and use animal drug fees. 
Sec. 104. Reauthorization; reporting requirements. 
Sec. 105. Savings clause. 
Sec. 106. Effective date. 
Sec. 107. Sunset dates. 
TITLE II—ANIMAL GENERIC DRUG USER FEE AMENDMENTS 
Sec. 201. Short title; finding. 
Sec. 202. Authority to assess and use generic new animal drug fees. 
Sec. 203. Reauthorization; reporting requirements. 
Sec. 204. Savings clause. 
Sec. 205. Effective date. 
Sec. 206. Sunset dates. 
TITLE I—ANIMAL DRUG USER 
FEE AMENDMENTS 
SEC. 101. SHORT TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the 
‘‘Animal Drug User Fee Amendments of 2013’’. 
(b) FINDING.—Congress finds that the fees authorized 
by the amendments made in this title will be dedicated to-
ward expediting the animal drug development process and 
the review of new and supplemental animal drug applica-
tions and investigational animal drug submissions as set 
forth in the goals identified, for purposes of part 4 of sub-
chapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act, in the letters from the Secretary of Health 
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and Human Services to the Chairman of the Committee on 
Energy and Commerce of the House of Representatives and 
the Chairman of the Committee on Health, Education, 
Labor, and Pensions of the Senate as set forth in the Con-
gressional Record. 
SEC. 102. DEFINITIONS. 
Section 739 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–11) is amended to read as follows: 
‘‘SEC. 739. DEFINITIONS. 
‘‘For purposes of this part: 
‘‘(1) The term ‘animal drug application’ means 
an application for approval of any new animal drug 
submitted under section 512(b)(1). Such term does not 
include either a new animal drug application sub-
mitted under section 512(b)(2) or a supplemental ani-
mal drug application. 
‘‘(2) The term ‘supplemental animal drug appli-
cation’ means— 
‘‘(A) a request to the Secretary to approve 
a change in an animal drug application which 
has been approved; or 
‘‘(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. 
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‘‘(3) The term ‘animal drug product’ means each 
specific strength or potency of a particular active in-
gredient or ingredients in final dosage form marketed 
by a particular manufacturer or distributor, 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 ani-
mal drug application has been approved. 
‘‘(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 ani-
mal drug application or a supplemental animal 
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 applica-
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tion or supplemental animal drug application 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 mix-
ing 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 
drug applications, supplemental animal drug appli-
cations, and investigational animal drug submissions: 
‘‘(A) The activities necessary for the review 
of animal drug applications, supplemental ani-
mal drug applications, and investigational ani-
mal drug submissions. 
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‘‘(F) Development of standards for products 
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 applications’ 
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 committees 
consulted with respect to the review of specific 
animal drug applications, supplemental animal 
drug applications, or investigational animal 
drug submissions, and costs related to such offi-
cers, employees, committees, and contractors, in-
cluding costs for travel, education, and recruit-
ment and other personnel activities; 
‘‘(B) management of information and the 
acquisition, maintenance, and repair of com-
puter resources; 
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‘‘(C) leasing, maintenance, renovation, and 
repair of facilities and acquisition, maintenance, 
and repair of fixtures, furniture, scientific equip-
ment, and other necessary materials and sup-
plies; and 
‘‘(D) collecting fees under section 740 and 
accounting for resources allocated for the review 
of animal drug applications, supplemental ani-
mal drug applications, and investigational ani-
mal drug submissions. 
‘‘(10) The term ‘adjustment factor’ applicable to 
a fiscal year refers to the formula set forth in section 
735(8) with the base or comparator month being Oc-
tober 2002. 
‘‘(11) The term ‘person’ includes an affiliate 
thereof. 
‘‘(12) The term ‘affiliate’ refers to the definition 
set forth in section 735(11).’’. 
SEC. 103. 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: 
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‘‘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 accordance 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 percent of 
the amount of the fee under clause (i), for— 
‘‘(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 
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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 person’s 
licensee, assignee, or successor) shall not be sub-
ject to a fee under subparagraph (A). 
‘‘(D) REFUND OF FEE IF APPLICATION RE-
FUSED FOR FILING.—The Secretary shall refund 
75 percent of the fee paid under subparagraph 
(B) for any animal drug application or supple-
mental animal drug application which is refused 
for filing. 
‘‘(E) REFUND
OF
FEE
IF
APPLICATION 
WITHDRAWN.—If an animal drug application or 
a supplemental animal drug application is with-
drawn after the application or supplement was 
filed, the Secretary may refund the fee or portion 
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of the fee paid under subparagraph (B) if no 
substantial work was performed on the applica-
tion or supplement after the application or sup-
plement was filed. The Secretary shall have the 
sole discretion to refund the fee under this para-
graph. A determination by the Secretary con-
cerning a refund under this paragraph shall not 
be reviewable. 
‘‘(2) ANIMAL DRUG PRODUCT FEE.— 
‘‘(A) IN GENERAL.—Each person— 
‘‘(i) 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 submitted 
for listing under section 510; and 
‘‘(ii) who, after September 1, 2003, had 
pending before the Secretary an animal 
drug application or supplemental animal 
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-
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listing under section 510 if the animal drug 
product has been withdrawn from listing and re-
listed. After such fee is paid for that fiscal year, 
such fee shall be due each subsequent fiscal 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 fis-
cal year in which the fee is payable. 
‘‘(3) ANIMAL DRUG ESTABLISHMENT FEE.— 
‘‘(A) IN GENERAL.—Each person— 
‘‘(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 submitted 
for listing under section 510; and 
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‘‘(iii) who, after September 1, 2003, 
had pending before the Secretary an animal 
drug application or supplemental animal 
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 manu-
factures 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 dur-
ing the fiscal year. 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. 
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‘‘(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 ani-
mal drug products and prescription drug 
products, as defined in section 735(3), such 
establishment shall be assessed both the ani-
mal drug establishment fee and the pre-
scription drug establishment fee, as set forth 
in section 736(a)(2), within a single fiscal 
year. 
‘‘(4) ANIMAL DRUG SPONSOR FEE.— 
‘‘(A) IN GENERAL.—Each person— 
‘‘(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 animal 
drug application, a supplemental animal 
drug application, or an investigational ani-
mal drug submission, 
shall be assessed an annual sponsor fee as estab-
lished under subsection (c). 
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‘‘(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)— 
‘‘(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 paragraph 
(1)— 
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‘‘(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.— 
‘‘(1) ANNUAL FEE SETTING.—The Secretary shall 
establish, 60 days before the start of each fiscal year 
beginning after September 30, 2003, for that fiscal 
year, animal drug application fees, supplemental ani-
mal 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 adjusted 
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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, multi-
plied by the average proportion of personnel 
compensation 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; 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 
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preceding 4 fiscal years for which data are avail-
able. 
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 revenue 
amounts established in subsection (b) are adjusted for 
inflation in accordance with paragraph (2), the rev-
enue amounts shall be further adjusted for such fiscal 
year to reflect changes in the workload of the Sec-
retary for the process for the review 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 applica-
tions for which data with respect to safety or ef-
fectiveness are required, manufacturing supple-
mental animal drug applications, investiga-
tional animal drug study submissions, and in-
vestigational animal drug protocol submissions 
submitted to the Secretary; 
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‘‘(B) the Secretary shall publish in the Fed-
eral Register the fees resulting from such adjust-
ment 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 fiscal 
year established in subsection (b), as adjusted for 
inflation under paragraph (2). 
‘‘(4) FINAL YEAR ADJUSTMENT.—For fiscal year 
2018, the Secretary may, in addition to other adjust-
ments under this subsection, further increase the fees 
under this section, if such an adjustment is 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 fis-
cal year 2019. If the Food and Drug Administration 
has carryover balances for the process for the review 
of animal drug applications in excess of 3 months of 
such operating reserves, then this adjustment will not 
be made. If this adjustment is necessary, then the ra-
tionale for the amount of the increase shall be con-
tained 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 
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may not exceed the total costs for such fiscal year for 
the resources allocated for the process for the review 
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 because of 
limited resources available to such person or 
other circumstances; 
‘‘(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 applica-
tions for such person; 
‘‘(C) the animal drug application or supple-
mental animal drug application is intended sole-
ly 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 successor 
regulation)) intended for use in the manu-
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facture of Type C free-choice medicated 
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 
‘‘(E) the sponsor involved is a small busi-
ness submitting its first animal drug application 
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 employ-
ees 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 
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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 ap-
plication fees for all subsequent animal drug ap-
plications and supplemental animal drug appli-
cations for which safety or effectiveness data are 
required in the same manner as an entity that 
does not qualify as a small business. 
‘‘(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 animal 
drug application or supplemental animal drug application 
submitted 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 person 
have been paid. An investigational animal drug submission 
under section 739(5)(B) that is submitted by a person sub-
ject to fees under subsection (a) shall be considered incom-
plete and shall not be accepted for review by the Secretary 
until all fees owed by such person have been paid. The Sec-
retary may discontinue review of any animal drug applica-
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tion, supplemental animal drug application, or investiga-
tional animal drug submission from a person if such person 
has not submitted for payment all fees owed under this sec-
tion 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 
fiscal year 2003 unless appropriations for salaries 
and expenses of the Food and Drug Administration 
for such fiscal year (excluding the amount of fees ap-
propriated for such fiscal year) are equal to or greater 
than the amount of appropriations for the salaries 
and expenses of the Food and Drug Administration 
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 in-
volved. 
‘‘(2) AUTHORITY.—If the Secretary does not as-
sess 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 assess 
such fees, the Secretary may assess and collect such 
fees, without any modification in the rate, for animal 
drug applications, supplemental animal drug appli-
cations, investigational animal drug submissions, 
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animal drug sponsors, animal drug establishments, 
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.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2)(C), 
fees authorized under subsection (a) shall be collected 
and available for obligation only to the extent and in 
the amount provided in advance in appropriations 
Acts. Such fees are authorized to be appropriated to 
remain available until expended. Such sums as may 
be necessary may be transferred from the Food and 
Drug Administration salaries and expenses appro-
priation account without fiscal year limitation 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 other-
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wise made available for obligation for such 
fiscal year; and 
‘‘(ii) shall be available to defray in-
creases in the costs of the resources allocated 
for the process for the review of animal drug 
applications (including increases in 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) over such costs, excluding 
costs paid from fees collected under this sec-
tion, for fiscal year 2003 multiplied by the 
adjustment factor. 
‘‘(B) COMPLIANCE.—The Secretary shall be 
considered to have met the requirements of sub-
paragraph (A)(ii) in any fiscal year if the costs 
funded by appropriations and allocated for the 
process for the review of animal drug applica-
tions— 
‘‘(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-
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lowing the subsequent fiscal year are de-
creased by the amount in excess of 3 percent 
by which such costs fell below the level speci-
fied in subparagraph (A)(ii); and 
‘‘(II) such costs are not more than 5 
percent below the level specified in subpara-
graph (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 accordance 
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 sec-
tion an amount equal to the total revenue amount de-
termined under subsection (b) for the fiscal 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 collected 
under this section for fiscal years 2014 through 
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2016 and the amount of fees estimated to be col-
lected under this section for fiscal year 2017 (in-
cluding any increased fee collections attributable 
to subparagraph (B)), exceeds the 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 sub-
tracted from the amount of fees that would other-
wise be authorized to be collected under this sec-
tion pursuant to appropriation Acts for fiscal 
year 2018. 
‘‘(B) RECOVERY
OF
COLLECTION
SHORT-
FALLS.— 
‘‘(i) FISCAL
YEAR
2016.—For fiscal 
year 2016, the amount of fees otherwise au-
thorized to be collected under this section 
shall be increased by the amount, if any, by 
which the amount collected under this sec-
tion and appropriated for fiscal year 2014 
falls below the amount of fees authorized for 
fiscal year 2014 under paragraph (3). 
‘‘(ii) FISCAL
YEAR
2017.—For fiscal 
year 2017, the amount of fees otherwise au-
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‘‘(i) WRITTEN REQUESTS FOR WAIVERS, REDUCTIONS, 
AND REFUNDS.—To qualify for consideration for 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 applica-
tions, be reduced to offset the number of officers, employees, 
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. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 740A of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–13) is amended to read as follows: 
‘‘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 Pen-
sions of the Senate a report concerning the progress of the 
Food and Drug Administration in achieving the goals iden-
tified in the letters described in section 101(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 applications and investiga-
tional animal drug submissions during such fiscal year, the 
future plans of the Food and Drug Administration for meet-
ing the goals, the review times for abbreviated new animal 
drug applications, and the administrative procedures 
adopted by the Food and Drug Administration to ensure 
that review times for abbreviated new animal drug applica-
tions are not increased from their current level due to ac-
tivities 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 author-
ity for such fees during such fiscal year and the use, by 
the Food and Drug Administration, of the fees collected dur-
ing 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 respect 
to the goals, and plans for meeting the goals, for the 
process for the review of animal drug applications 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 negotiations 
with the regulated industry, the Secretary shall hold 
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discussions with representatives of veterinary, patient, 
and consumer advocacy groups to continue discus-
sions of their views on the reauthorization and their 
suggestions for changes to this part as expressed 
under paragraph (2). 
‘‘(4) PUBLIC REVIEW OF RECOMMENDATIONS.— 
After negotiations with the regulated industry, the 
Secretary shall— 
‘‘(A) present the recommendations developed 
under paragraph (1) to the congressional com-
mittees 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 rec-
ommendations; 
‘‘(D) hold a meeting at which the public 
may present its views on such recommendations; 
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 recommendations 
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