under paragraph (4), a summary of the views and 
comments received under such paragraph, and any 
changes made to the recommendations 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 Congress, the Sec-
retary shall make publicly available, on the 
Internet Web site of the Food and Drug Admin-
istration, minutes ofPublic Law 110-316 (122 
Stat. 3509)’’ all negotiation meetings conducted 
under this subsection between the Food and Drug 
Administration and the regulated 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. 105. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this title, 
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 this 
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title, shall continue to be in effect with respect to animal 
drug applications and supplemental animal drug applica-
tions (as defined in such part as of such day) that on or 
after October 1, 2008, but before October 1, 2013, were ac-
cepted by the Food and Drug Administration for filing with 
respect to assessing and collecting any fee required by such 
part for a fiscal year prior to fiscal year 2014. 
SEC. 106. EFFECTIVE DATE. 
The amendments made by this title shall take effect 
on October 1, 2013, or the date of enactment of this title, 
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 title, shall be assessed for 
all animal drug applications and supplemental animal 
drug applications received on or after October 1, 2013, re-
gardless of the date of the enactment of this title. 
SEC. 107. 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.—Public Law 
110–316 (122 Stat. 3509) is amended in the table of 
contents in section 1, by striking the item relating to 
section 108. 
(d) TECHNICAL CLARIFICATION.—Effective November 
18, 2003, section 5 of the Animal Drug User Fee Act of 
2003 (Public Law 108–130) is repealed. 
TITLE II—ANIMAL GENERIC 
DRUG USER FEE AMENDMENTS 
SECTION 201. SHORT TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the 
‘‘Animal Generic Drug User Fee Amendments of 2013’’. 
(b) FINDING.—The fees authorized by this title will be 
dedicated toward expediting the generic new animal drug 
development process and the review of abbreviated applica-
tions for generic new animal drugs, supplemental abbre-
viated applications for generic new animal drugs, and in-
vestigational submissions for generic new animal drugs as 
set forth in the goals identified in the letters from the Sec-
retary of Health 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 
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Health, Education, Labor, and Pensions of the Senate as 
set forth in the Congressional Record. 
SEC. 202. AUTHORITY TO ASSESS AND USE GENERIC NEW 
ANIMAL DRUG FEES. 
Section 741 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–21) is amended to read as follows: 
‘‘SEC. 741. AUTHORITY TO ASSESS AND USE GENERIC NEW 
ANIMAL DRUG FEES. 
‘‘(a) TYPES OF FEES.—Beginning with respect to fis-
cal year 2009, the Secretary shall assess and collect fees in 
accordance with this section as follows: 
‘‘(1) ABBREVIATED APPLICATION FEE.— 
‘‘(A) IN GENERAL.—Each person that sub-
mits, on or after July 1, 2008, an abbreviated 
application for a generic new animal drug shall 
be subject to a fee as established in subsection (c) 
for such an application. 
‘‘(B) PAYMENT.—The fee required by sub-
paragraph (A) shall be due upon submission of 
the abbreviated application. 
‘‘(C) EXCEPTIONS.— 
‘‘(i) 
PREVIOUSLY
FILED
APPLICA-
TION.—If an abbreviated application was 
submitted by a person that paid the fee for 
such application, was accepted for filing, 
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and was not approved or was withdrawn 
(without a waiver or refund), the submis-
sion of an abbreviated application for the 
same product by the same person (or the 
person’s licensee, assignee, or successor) 
shall not be subject to a fee under subpara-
graph (A). 
‘‘(ii) CERTAIN ABBREVIATED APPLICA-
TIONS
INVOLVING
COMBINATION
ANIMAL 
DRUGS.—An abbreviated application for an 
animal drug described in section 512(d)(4) 
and submitted on or after October 1, 2013, 
shall be subject to a fee equal to 50 percent 
of the amount of the abbreviated application 
fee established in subsection (c). 
‘‘(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 abbreviated application which is re-
fused for filing. 
‘‘(E) REFUND
OF
FEE
IF
APPLICATION 
WITHDRAWN.—If an abbreviated application is 
withdrawn after the application was filed, the 
Secretary may refund the fee or portion of the fee 
paid under subparagraph (B) if no substantial 
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work was performed on the application after the 
application was filed. The Secretary shall have 
the sole discretion to refund the fee under this 
subparagraph. A determination by the Secretary 
concerning a refund under this subparagraph 
shall not be reviewable. 
‘‘(2) GENERIC
NEW
ANIMAL
DRUG
PRODUCT 
FEE.— 
‘‘(A) IN GENERAL.—Each person— 
‘‘(i) who is named as the applicant in 
an abbreviated application or supplemental 
abbreviated application for a generic new 
animal drug product which has been sub-
mitted for listing under section 510; and 
‘‘(ii) who, after September 1, 2008, had 
pending before the Secretary an abbreviated 
application or supplemental abbreviated ap-
plication, 
shall pay for each such generic new 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 
generic new animal drug product is first sub-
mitted for listing under section 510, or is sub-
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mitted for relisting under section 510 if the ge-
neric new animal drug product has been with-
drawn from listing and relisted. After such fee is 
paid for that fiscal year, such fee shall be due 
each subsequent fiscal year that the product re-
mains 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 generic new animal drug 
product for a fiscal year in which the fee is pay-
able. 
‘‘(3) GENERIC
NEW
ANIMAL
DRUG
SPONSOR 
FEE.— 
‘‘(A) IN GENERAL.—Each person— 
‘‘(i) who meets the definition of a ge-
neric new animal drug sponsor within a 
fiscal year; and 
‘‘(ii) who, after September 1, 2008, had 
pending before the Secretary an abbreviated 
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application, a supplemental abbreviated ap-
plication, or an investigational submission, 
shall be assessed an annual generic new animal 
drug sponsor fee as established under subsection 
(c). 
‘‘(B) PAYMENT; FEE DUE DATE.—Such fee 
shall be due each fiscal year 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) AMOUNT OF FEE.—Each generic new 
animal drug sponsor shall pay only 1 such fee 
each fiscal year, as follows: 
‘‘(i) 100 percent of the amount of the 
generic new animal drug sponsor fee pub-
lished for that fiscal year under subsection 
(c) for an applicant with more than 6 ap-
proved abbreviated applications. 
‘‘(ii) 75 percent of the amount of the 
generic new animal drug sponsor fee pub-
lished for that fiscal year under subsection 
(c) for an applicant with more than 1 and 
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fewer than 7 approved abbreviated applica-
tions. 
‘‘(iii) 50 percent of the amount of the 
generic new animal drug sponsor fee pub-
lished for that fiscal year under subsection 
(c) for an applicant with 1 or fewer ap-
proved abbreviated applications. 
‘‘(b) FEE AMOUNTS.—Subject to subsections (c), (d), 
(f), and (g), the fees required under subsection (a) shall be 
established to generate fee revenue amounts as follows: 
‘‘(1) TOTAL FEE REVENUES FOR APPLICATION 
FEES.—The total fee revenues to be collected in abbre-
viated application fees under subsection (a)(1) shall 
be $1,832,000 for fiscal year 2014, $1,736,000 for fis-
cal year 2015, $1,857,000 for fiscal year 2016, 
$1,984,000 for fiscal year 2017, and $2,117,000 for 
fiscal year 2018. 
‘‘(2) TOTAL
FEE
REVENUES
FOR
PRODUCT 
FEES.—The total fee revenues to be collected in ge-
neric new animal drug product fees under subsection 
(a)(2) shall be $2,748,000 for fiscal year 2014, 
$2,604,000 for fiscal year 2015, $2,786,000 for fiscal 
year 2016, $2,976,000 for fiscal year 2017, and 
$3,175,000 for fiscal year 2018. 
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‘‘(3) TOTAL
FEE
REVENUES
FOR
SPONSOR 
FEES.—The total fee revenues to be collected in ge-
neric new animal drug sponsor fees under subsection 
(a)(3) shall be $2,748,000 for fiscal year 2014, 
$2,604,000 for fiscal year 2015, $2,786,000 for fiscal 
year 2016, $2,976,000 for fiscal year 2017, and 
$3,175,000 for fiscal year 2018. 
‘‘(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, 2008, for that fiscal 
year, abbreviated application fees, generic new ani-
mal drug sponsor fees, and generic new animal drug 
product fees, based on the revenue amounts established 
under subsection (b) and the adjustments provided 
under this subsection. 
‘‘(2) WORKLOAD ADJUSTMENT.—The fee revenues 
shall be adjusted each fiscal year after fiscal year 
2014 to reflect changes in review workload. With re-
spect to such adjustment: 
‘‘(A) This adjustment shall be determined 
by the Secretary based on a weighted average of 
the change in the total number of abbreviated 
applications for generic new animal drugs, man-
ufacturing supplemental abbreviated applica-
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tions for generic new animal drugs, investiga-
tional generic new animal drug study submis-
sions, and investigational generic new animal 
drug protocol submissions submitted to the Sec-
retary. The Secretary shall publish in the Fed-
eral Register the fees resulting from this adjust-
ment and the supporting methodologies. 
‘‘(B) Under no circumstances shall this 
workload adjustment result in fee revenues for a 
fiscal year that are less than the fee revenues for 
that fiscal year established in subsection (b). 
‘‘(3) 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 ab-
breviated applications for generic new animal drugs 
for the first 3 months of fiscal year 2019. If the Food 
and Drug Administration has carryover balances for 
the process for the review of abbreviated applications 
for generic new animal drugs in excess of 3 months 
of such operating reserves, then this adjustment shall 
not be made. If this adjustment is necessary, then the 
rationale for the amount of the increase shall be con-
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tained in the annual notice setting fees for fiscal year 
2018. 
‘‘(4) 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 review 
of abbreviated applications for generic new animal 
drugs. 
‘‘(d) FEE WAIVER OR REDUCTION.—The Secretary 
shall grant a waiver from or a reduction of 1 or more fees 
assessed under subsection (a) where the Secretary finds that 
the generic new animal drug is intended solely to provide 
for a minor use or minor species indication. 
‘‘(e) EFFECT OF FAILURE TO PAY FEES.—An abbre-
viated application for a generic new animal drug submitted 
by a person subject to fees under subsection (a) shall be con-
sidered incomplete and shall not be accepted for filing by 
the Secretary until all fees owed by such person have been 
paid. An investigational submission for a generic new ani-
mal drug that is submitted 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 dis-
continue review of any abbreviated application for a ge-
neric new animal drug, supplemental abbreviated applica-
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tion for a generic new animal drug, or investigational sub-
mission for a generic new animal drug 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 
fiscal year 2008 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 abbre-
viated applications, generic new animal drug spon-
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sors, and generic new animal drug products at any 
time in such fiscal year notwithstanding the provi-
sions 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 abbreviated applications for generic new animal 
drugs. 
‘‘(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 
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specified in appropriation Acts, or other-
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 abbreviated 
applications for generic new animal drugs 
(including increases in such costs for an ad-
ditional number of full-time equivalent po-
sitions in the Department of Health and 
Human Services to be engaged in such proc-
ess) over such costs, excluding costs paid 
from fees collected under this section, for fis-
cal year 2008 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 abbreviated applications 
for generic new animal drugs— 
‘‘(i) are not more than 3 percent below 
the level specified in subparagraph (A)(ii); 
or 
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‘‘(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 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.— 
There are authorized to be appropriated for fees under 
this section— 
‘‘(A) $7,328,000 for fiscal year 2014; 
‘‘(B) $6,944,000 for fiscal year 2015; 
‘‘(C) $7,429,000 for fiscal year 2016; 
‘‘(D) $7,936,000 for fiscal year 2017; and 
‘‘(E) $8,467,000 for fiscal year 2018; 
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as adjusted to reflect adjustments in the total fee reve-
nues made under this section and changes in the total 
amounts collected by abbreviated application fees, ge-
neric new animal drug sponsor fees, and generic new 
animal drug product fees. 
‘‘(4) OFFSET.—If the sum of the cumulative 
amount of fees collected under this section for the fis-
cal years 2014 through 2016 and the amount of fees 
estimated to be collected under this section for fiscal 
year 2017 exceeds the cumulative amount appro-
priated under paragraph (3) for the fiscal years 2014 
through 2017, the excess amount shall be credited to 
the appropriation account of the Food and Drug Ad-
ministration as provided in paragraph (1), and shall 
be subtracted from the amount of fees that would oth-
erwise be authorized to be collected under this section 
pursuant to appropriation Acts for fiscal year 2018. 
‘‘(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, REDUCTIONS, 
AND REFUNDS.—To qualify for consideration for a waiver 
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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 abbreviated applica-
tions for generic new animal drugs, be reduced to offset the 
number of officers, employees, and advisory committees so 
engaged. 
‘‘(k) DEFINITIONS.—In this section and section 742: 
‘‘(1) ABBREVIATED APPLICATION FOR A GENERIC 
NEW ANIMAL DRUG.—The terms ‘abbreviated applica-
tion for a generic new animal drug’ and ‘abbreviated 
application’ mean an abbreviated application for the 
approval of any generic new animal drug submitted 
under section 512(b)(2). Such term does not include 
a supplemental abbreviated application for a generic 
new animal drug. 
‘‘(2) ADJUSTMENT FACTOR.—The term ‘adjust-
ment factor’ applicable to a fiscal year is the Con-
sumer Price Index for all urban consumers (all items; 
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United States city average) for October of the pre-
ceding fiscal year divided by— 
‘‘(A) for purposes of subsection (f)(1), such 
Index for October 2002; and 
‘‘(B) for purposes of subsection (g)(2)(A)(ii), 
such Index for October 2007. 
‘‘(3) COSTS OF RESOURCES ALLOCATED FOR THE 
PROCESS FOR THE REVIEW OF ABBREVIATED APPLI-
CATIONS
FOR
GENERIC
NEW
ANIMAL
DRUGS.—The 
term ‘costs of resources allocated for the process for the 
review of abbreviated applications for generic new 
animal drugs’ means the expenses in connection with 
the process for the review of abbreviated applications 
for generic new animal drugs 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 
abbreviated applications, supplemental abbre-
viated applications, or investigational submis-
sions, and costs related to such officers, employ-
ees, committees, and contractors, including costs 
for travel, education, and recruitment and other 
personnel activities; 
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‘‘(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 equip-
ment, and other necessary materials and sup-
plies; and 
‘‘(D) collecting fees under this section and 
accounting for resources allocated for the review 
of abbreviated applications, supplemental abbre-
viated applications, and investigational submis-
sions. 
‘‘(4) FINAL DOSAGE FORM.—The term ‘final dos-
age form’ means, with respect to a generic new ani-
mal drug product, a finished dosage form which is 
approved for administration to an animal without 
substantial further manufacturing. Such term in-
cludes generic new animal drug products intended for 
mixing in animal feeds. 
‘‘(5) GENERIC
NEW
ANIMAL
DRUG.—The term 
‘generic new animal drug’ means a new animal drug 
that is the subject of an abbreviated application. 
‘‘(6) GENERIC NEW ANIMAL DRUG PRODUCT.— 
The term ‘generic new animal drug product’ means 
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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 abbreviated application for a 
generic new animal drug or a supplemental abbre-
viated application has been approved. 
‘‘(7) GENERIC NEW ANIMAL DRUG SPONSOR.— 
The term ‘generic new animal drug sponsor’ means 
either an applicant named in an abbreviated applica-
tion for a generic new animal drug 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 investigational submission for 
a generic new animal drug that has not been termi-
nated or otherwise rendered inactive by the Secretary. 
‘‘(8) INVESTIGATIONAL SUBMISSION FOR A GE-
NERIC
NEW
ANIMAL
DRUG.—The terms ‘investiga-
tional submission for a generic new animal drug’ and 
‘investigational submission’ mean— 
‘‘(A) the filing of a claim for an investiga-
tional exemption under section 512(j) for a ge-
neric new animal drug intended to be the subject 
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of an abbreviated application or a supplemental 
abbreviated application; or 
‘‘(B) the submission of information for the 
purpose of enabling the Secretary to evaluate the 
safety or effectiveness of a generic new animal 
drug in the event of the filing of an abbreviated 
application or supplemental abbreviated applica-
tion for such drug. 
‘‘(9) PERSON.—The term ‘person’ includes an af-
filiate thereof (as such term is defined in section 
735(11)). 
‘‘(10) PROCESS
FOR
THE
REVIEW
OF
ABBRE-
VIATED
APPLICATIONS
FOR
GENERIC
NEW
ANIMAL 
DRUGS.—The term ‘process for the review of abbre-
viated applications for generic new animal drugs’ 
means the following activities of the Secretary with 
respect to the review of abbreviated applications, sup-
plemental abbreviated applications, and investiga-
tional submissions: 
‘‘(A) The activities necessary for the review 
of abbreviated applications, supplemental abbre-
viated applications, and investigational submis-
sions. 
‘‘(B) The issuance of action letters which 
approve abbreviated applications or supple-
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mental abbreviated applications or which set 
forth in detail the specific deficiencies in abbre-
viated applications, supplemental abbreviated 
applications, or investigational submissions and, 
where appropriate, the actions necessary to place 
such applications, supplemental applications, or 
submissions in condition for approval. 
‘‘(C) The inspection of generic new animal 
drug establishments and other facilities under-
taken as part of the Secretary’s review of pend-
ing abbreviated applications, supplemental ab-
breviated applications, and investigational sub-
missions. 
‘‘(D) Monitoring of research conducted in 
connection with the review of abbreviated appli-
cations, supplemental abbreviated applications, 
and investigational submissions. 
‘‘(E) The development of regulations and 
policy related to the review of abbreviated appli-
cations, supplemental abbreviated applications, 
and investigational submissions. 
‘‘(F) Development of standards for products 
subject to review. 
‘‘(G) Meetings between the agency and the 
generic new animal drug sponsor. 
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‘‘(H) Review of advertising and labeling 
prior to approval of an abbreviated application 
or supplemental abbreviated application, but not 
after such application has been approved. 
‘‘(11) SUPPLEMENTAL
ABBREVIATED
APPLICA-
TION FOR GENERIC NEW ANIMAL DRUG.—The terms 
‘supplemental abbreviated application for a generic 
new animal drug’ and ‘supplemental abbreviated ap-
plication’ mean a request to the Secretary to approve 
a change in an approved abbreviated application.’’. 
SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 742 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–22) is amended to read as follows: 
‘‘SEC. 
742. 
REAUTHORIZATION; 
REPORTING 
REQUIRE-
MENTS. 
‘‘(a) PERFORMANCE REPORTS.—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 Health, Education, Labor, and Pensions of the Senate, 
and the Committee on Energy and Commerce of the House 
of Representatives a report concerning the progress of the 
Food and Drug Administration in achieving the goals iden-
tified in the letters described in section 201(b) of the Animal 
Generic Drug User Fee Amendments of 2013 toward expe-
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diting the generic new animal drug development process 
and the review of abbreviated applications for generic new 
animal drugs, supplemental abbreviated applications for 
generic new animal drugs, and investigational submissions 
for generic new animal drugs during such fiscal year. 
‘‘(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 
Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of 
Representatives a report on the implementation of the au-
thority 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 Congress with respect to 
the goals, and plans for meeting the goals, for the 
process for the review of abbreviated applications for 
generic new animal drugs for the first 5 fiscal years 
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after fiscal year 2018, and for the reauthorization of 
this part for such fiscal years, the Secretary shall con-
sult 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) 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 
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