I 
113TH CONGRESS 
1ST SESSION H. R. 1408 
To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user 
fee programs relating to generic new animal drugs. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 9, 2013 
Mr. GARDNER (for himself, Mr. SHIMKUS, 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 generic 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 Generic Drug User Fee Amendments of 2013’’. 
(b) FINDING.—The fees authorized by this Act will 
be dedicated toward expediting the generic new animal 
drug development process and the review of abbreviated 
applications for generic new animal drugs, supplemental 
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
abbreviated applications for generic new animal drugs, 
and investigational submissions for generic new animal 
drugs as set forth in the goals identified in the letters from 
the Secretary of Health and Human Services to the Chair-
man of the Committee on Energy and Commerce of the 
House of Representatives and the Chairman of the Com-
mittee on Health, Education, Labor, and Pensions of the 
Senate as set forth in the Congressional Record. 
SEC. 2. 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. 
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
‘‘(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, 
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 sub-
paragraph (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 per-
cent of the amount of the abbreviated ap-
plication fee established in subsection (c). 
‘‘(D) REFUND OF FEE IF APPLICATION RE-
FUSED FOR FILING.—The Secretary shall re-
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
fund 75 percent of the fee paid under subpara-
graph (B) for any abbreviated application which 
is refused 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 substan-
tial 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 abbre-
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
viated application or supplemental abbre-
viated application, 
shall pay for each such generic new animal 
drug product the annual fee established in sub-
section (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-
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. 
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
‘‘(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 abbre-
viated application, a supplemental abbre-
viated application, or an investigational 
submission, 
shall be assessed an annual generic new animal 
drug sponsor fee as established under sub-
section (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: 
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
‘‘(2) WORKLOAD ADJUSTMENT.—The fee reve-
nues shall be adjusted each fiscal year after fiscal 
year 2014 to reflect changes in review workload. 
With respect 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 abbre-
viated applications for generic new animal 
drugs, manufacturing supplemental abbreviated 
applications for generic new animal drugs, in-
vestigational generic new animal drug study 
submissions, and investigational generic new 
animal drug protocol submissions submitted to 
the Secretary. The Secretary shall publish in 
the Federal Register the fees resulting from 
this adjustment and the supporting methodolo-
gies. 
‘‘(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 
adjustments under this subsection, further increase 
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
the fees under this section, if such an adjustment is 
necessary, to provide for up to 3 months of oper-
ating reserves of carryover user fees for the process 
for the review of abbreviated 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 re-
serves, then this adjustment shall 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. 
‘‘(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 re-
view of abbreviated applications for generic new ani-
mal 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 pro-
vide for a minor use or minor species indication. 
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
‘‘(e) EFFECT OF FAILURE TO PAY FEES.—An abbre-
viated application for a generic new animal drug sub-
mitted 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 per-
son have been paid. An investigational submission for a 
generic new animal 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 Sec-
retary until all fees owed by such person have been paid. 
The Secretary may discontinue review of any abbreviated 
application for a generic new animal drug, supplemental 
abbreviated application for a generic new animal drug, or 
investigational submission for a generic new animal drug 
from a person if such person has not submitted for pay-
ment 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 
appropriated for such fiscal year) are equal to or 
greater than the amount of appropriations for the 
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
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 
abbreviated applications, generic new animal drug 
sponsors, and generic new animal drug products at 
any time in such fiscal year notwithstanding the pro-
visions 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 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-
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
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 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 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-
cated for the process for the review of ab-
breviated applications for generic new ani-
mal drugs (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 
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00013
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
costs paid from fees collected under this 
section, for fiscal year 2008 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 abbreviated appli-
cations for generic new animal drugs— 
‘‘(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 
‘‘(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 
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00014
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
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.— 
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; 
as adjusted to reflect adjustments in the total fee 
revenues made under this section and changes in the 
total amounts collected by abbreviated application 
fees, generic new animal drug sponsor fees, and ge-
neric new animal drug product fees. 
‘‘(4) OFFSET.—If the sum of the cumulative 
amount of fees collected under this section for the 
fiscal years 2014 through 2016 and the amount of 
fees estimated to be collected under this section for 
fiscal year 2017 exceeds the cumulative amount ap-
propriated 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 Administration as provided in paragraph 
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00015
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
(1), and shall be subtracted from the amount of fees 
that would otherwise 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, REDUC-
TIONS, 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 abbreviated appli-
cations for generic new animal drugs, be reduced to offset 
the number of officers, employees, and advisory commit-
tees so engaged. 
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00016
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
‘‘(k) DEFINITIONS.—In this section and section 742: 
‘‘(1) ABBREVIATED
APPLICATION
FOR
A
GE-
NERIC NEW ANIMAL DRUG.—The terms ‘abbreviated 
application for a generic new animal drug’ and ‘ab-
breviated application’ mean an abbreviated applica-
tion 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; United States city average) for October of the 
preceding 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 
APPLICATIONS FOR GENERIC NEW ANIMAL DRUGS.— 
The term ‘costs of resources allocated for the proc-
ess for the review of abbreviated applications for ge-
neric new animal drugs’ means the expenses in con-
nection with the process for the review of abbre-
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00017
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
viated 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 com-
mittees consulted with respect to the review of 
specific abbreviated applications, supplemental 
abbreviated applications, or investigational sub-
missions, and costs related to such officers, em-
ployees, committees, and contractors, 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 this section and 
accounting for resources allocated for the re-
view of abbreviated applications, supplemental 
abbreviated applications, and investigational 
submissions. 
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00018
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
‘‘(4) FINAL
DOSAGE
FORM.—The term ‘final 
dosage form’ means, with respect to a generic new 
animal 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 
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 
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00019
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
has not been withdrawn by the Secretary, or a per-
son who has submitted an investigational submission 
for a generic new animal drug that has not been ter-
minated or otherwise rendered inactive by the Sec-
retary. 
‘‘(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 sub-
ject of an abbreviated application or a supple-
mental 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 ani-
mal drug in the event of the filing of an abbre-
viated application or supplemental abbreviated 
application for such drug. 
‘‘(9) PERSON.—The term ‘person’ includes an 
affiliate thereof (as such term is defined in section 
735(11)). 
‘‘(10) PROCESS FOR THE REVIEW OF ABBRE-
VIATED APPLICATIONS FOR GENERIC NEW ANIMAL 
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00020
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
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, 
supplemental abbreviated applications, and inves-
tigational submissions: 
‘‘(A) The activities necessary for the re-
view of abbreviated applications, supplemental 
abbreviated applications, and investigational 
submissions. 
‘‘(B) The issuance of action letters which 
approve abbreviated applications or supple-
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 applica-
tions, 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. 
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00021
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
‘‘(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 prod-
ucts subject to review. 
‘‘(G) Meetings between the agency and the 
generic new animal drug sponsor. 
‘‘(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 ap-
prove a change in an approved abbreviated applica-
tion.’’. 
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00022
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
SEC. 3. 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 fis-
cal 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 Com-
mittee 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 achiev-
ing the goals identified in the letters described in section 
1(b) of the Animal Generic Drug User Fee Amendments 
of 2013 toward expediting the generic new animal drug 
development process and the review of abbreviated appli-
cations for generic new animal drugs, supplemental abbre-
viated applications for generic new animal drugs, and in-
vestigational 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 
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00023
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
the Committee on Energy and Commerce of the House 
of Representatives 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 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 
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; 
‘‘(B) the Committee on Health, Education, 
Labor, and Pensions of the Senate; 
‘‘(C) scientific and academic experts; 
‘‘(D) veterinary professionals; 
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00024
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
‘‘(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 
hold discussions with representatives of veterinary, 
patient, and consumer advocacy groups to continue 
discussions of their views on the reauthorization and 
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00025
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
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-
tions under paragraph (4), a summary of the views 
and comments received under such paragraph, and 
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00026
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
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. 4. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this Act, 
part 5 of subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act, as in effect on the day before 
the date of enactment of this Act, shall continue to be 
in effect with respect to abbreviated applications for a ge-
neric new animal drug and supplemental abbreviated ap-
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00027
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
plications for a generic new animal drug (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 assess-
ing and collecting any fee required by such part for a fiscal 
year prior to fiscal year 2014. 
SEC. 5. 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 5 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 abbreviated applications for a generic new animal 
drug and supplemental abbreviated applications for a ge-
neric new animal drug received on or after October 1, 
2013, regardless of the date of enactment of this Act. 
SEC. 6. SUNSET DATES. 
(a) AUTHORIZATION.—Section 741 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) shall 
cease to be effective October 1, 2018. 
(b) REPORTING REQUIREMENTS.—Section 742 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
22) shall cease to be effective January 31, 2019. 
(c) PREVIOUS SUNSET PROVISION.— 
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00028
Fmt 6652
Sfmt 6201
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS
(1) IN GENERAL.—Section 204 of the Animal 
Generic Drug User Fee Act of 2008 (Public Law 
110–316) is repealed. 
(2) CONFORMING
AMENDMENT.—The Animal 
Generic Drug User Fee Act of 2008 (Public Law 
110–316) is amended in the table of contents in sec-
tion 1, by striking the item relating to section 204. 
Æ 
VerDate Mar 15 2010 
03:24 Apr 11, 2013
Jkt 029200
PO 00000
Frm 00029
Fmt 6652
Sfmt 6301
E:\BILLS\H1408.IH
H1408
jbell on DSK7SPTVN1PROD with BILLS