mittee on Health, Education, Labor, and Pensions 
of the Senate as set forth in the Congressional 
Record. 
SEC. 3. FEES RELATING TO ABBREVIATED APPLICATIONS 
FOR GENERIC NEW ANIMAL DRUGS. 
(a) REDESIGNATION.—Chapter VII (21 U.S.C. 371 
et seq.) is amended by redesignating sections 741, 742, 
and 746 as sections 745, 746, and 749, respectively. 
(b) AUTHORITY TO ASSESS AND USE GENERIC NEW 
ANIMAL DRUG FEES.—Subchapter C of chapter VII of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379f et seq.) is amended by adding at the end the fol-
lowing: 
‘‘PART 5—FEES RELATING TO GENERIC NEW 
ANIMAL DRUGS 
‘‘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 
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be subject to a fee as established in subsection 
(b) for such an application. 
‘‘(B) PAYMENT.—The fee required by sub-
paragraph (A) shall be due upon submission of 
the abbreviated application. 
‘‘(C) EXCEPTION FOR PREVIOUSLY FILED 
APPLICATION.—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was not approved or was withdrawn (without a 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 submission of an abbre-
viated 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 
subparagraph (A). 
‘‘(D) REFUND OF FEE IF APPLICATION RE-
FUSED FOR FILING.—The Secretary shall re-
fund 75 percent of the fee paid under subpara-
graph (B) for any 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WITHDRAWN.—If an abbreviated application is 
withdrawn after the application was filed, the 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-
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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.—Each person— 
‘‘(A) who is named as the applicant in an 
abbreviated application or supplemental abbre-
viated application for a generic new animal 
drug product which has been submitted for list-
ing under section 510, and 
‘‘(B) who, after September 1, 2008, had 
pending before the Secretary an abbreviated ap-
plication or supplemental abbreviated applica-
tion, 
shall pay for each such generic new animal drug 
product the annual fee established in subsection (b). 
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 submitted 
for relisting under section 510 if the generic new 
animal drug product has been withdrawn from list-
ing and relisted. After such fee is paid for that fiscal 
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year, such fee shall be payable on or before January 
31 of each year. Such fee shall be paid only once for 
each generic new animal drug product for a fiscal 
year in which the fee is payable. 
‘‘(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 fee established 
under subsection (b). The fee shall be paid on 
or before January 31 of each year. 
‘‘(B) 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 
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(c)(3) for an applicant with more than 6 
approved 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)(3) for an applicant with more than 1 
and fewer than 7 approved abbreviated ap-
plications. 
‘‘(iii) 50 percent of the amount of the 
generic new animal drug sponsor fee pub-
lished for that fiscal year under subsection 
(c)(3) for an applicant with 1 or fewer ap-
proved abbreviated applications. 
‘‘(b) FEE AMOUNTS.—Except as provided in sub-
section (a)(1) and 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 ab-
breviated application fees under subsection (a)(1) 
shall be $1,449,000 for fiscal year 2009, $1,532,000 
for fiscal year 2010, $1,619,000 for fiscal year 
2011, $1,712,000 for fiscal year 2012, and 
$1,809,000 for fiscal year 2013. 
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‘‘(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 $1,691,000 for fiscal year 2009, 
$1,787,000 for fiscal year 2010, $1,889,000 for fis-
cal year 2011, $1,997,000 for fiscal year 2012, and 
$2,111,000 for fiscal year 2013. 
‘‘(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 $1,691,000 for fiscal year 2009, 
$1,787,000 for fiscal year 2010, $1,889,000 for fis-
cal year 2011, $1,997,000 for fiscal year 2012, and 
$2,111,000 for fiscal year 2013. 
‘‘(c) ADJUSTMENTS.— 
‘‘(1) WORKLOAD ADJUSTMENT.—The fee reve-
nues shall be adjusted each fiscal year after fiscal 
year 2009 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-
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vestigational new animal drug study submis-
sions, and generic investigational new animal 
drug protocol submissions submitted to the Sec-
retary. The Secretary shall publish in the Fed-
eral Register the fees resulting from this ad-
justment 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). 
‘‘(2) FINAL
YEAR
ADJUSTMENT.—For fiscal 
year 2013, the Secretary may further increase the 
fees to provide for up to 3 months of operating re-
serves 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 
2014. If the Food and Drug Administration has car-
ryover balances for the process for the review of ab-
breviated applications for generic new animal drugs 
in excess of 3 months of such operating reserves, 
then this adjustment shall not be made. If this ad-
justment is necessary, then the rationale for the 
amount of the increase shall be contained in the an-
nual notice setting fees for fiscal year 2013. 
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‘‘(3) ANNUAL
FEE
SETTING.—The Secretary 
shall establish, 60 days before the start of each fis-
cal year beginning after September 30, 2008, for 
that fiscal year, abbreviated application fees, generic 
new animal drug sponsor fees, and generic new ani-
mal drug product fees based on the revenue amounts 
established under subsection (b) and the adjust-
ments provided under this subsection. 
‘‘(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. 
‘‘(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 
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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 
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, with the base or 
comparator being October 2002, applicable to the 
fiscal year involved. 
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‘‘(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.—Fees authorized under sub-
section (a) shall be collected and available for obliga-
tion only to the extent and in the amount provided 
in advance in appropriations Acts. Such fees are au-
thorized 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 appropriation account without 
fiscal year limitation to such appropriation account 
for salary and expenses with such fiscal year limita-
tion. The sums transferred shall be available solely 
for the process for the review of abbreviated applica-
tions for generic new animal drugs. 
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‘‘(2) 
COLLECTIONS
AND
APPROPRIATION 
ACTS.— 
‘‘(A) IN
GENERAL.—The fees authorized 
by this section— 
‘‘(i) shall be retained 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 only be collected and avail-
able to defray increases in the costs of the 
resources allocated for the process for the 
review of abbreviated applications for ge-
neric new animal drugs (including in-
creases 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 section, for fiscal 
year 2008 multiplied by the adjustment 
factor, with the base or comparator being 
October 2007. 
‘‘(B) COMPLIANCE.—The Secretary shall 
be considered to have met the requirements of 
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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). 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
There are authorized to be appropriated for fees 
under this section— 
‘‘(A) $4,831,000 for fiscal year 2009; 
‘‘(B) $5,106,000 for fiscal year 2010; 
‘‘(C) $5,397,000 for fiscal year 2011; 
‘‘(D) $5,706,000 for fiscal year 2012; and 
‘‘(E) $6,031,000 for fiscal year 2013; 
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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 2009 through 2011 and the amount of 
fees estimated to be collected under this section for 
fiscal year 2012 exceeds the cumulative amount ap-
propriated under paragraph (3) for the fiscal years 
2009 through 2012, the excess amount shall be 
credited to the appropriation account of the Food 
and Drug Administration as provided in paragraph 
(1), and shall be subtracted from the amount of fees 
that would otherwise be authorized to be collected 
under this section pursuant to appropriation Acts 
for fiscal year 2013. 
‘‘(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. 
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