IB 
Union Calendar No. 521 
110TH CONGRESS 
2D SESSION 
H. R. 6433 
[Report No. 110–805] 
To amend the Federal Food, Drug, and Cosmetic Act to establish a program 
of fees relating to generic new animal drugs. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 8, 2008 
Mr. PALLONE (for himself, Mr. DINGELL, Mr. BARTON of Texas, Mr. DEAL 
of Georgia, and Mr. TOWNS) introduced the following bill; which was re-
ferred to the Committee on Energy and Commerce 
JULY 30, 2008 
Additional sponsor: Ms. DEGETTE 
JULY 30, 2008 
Reported with an amendment, 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 July 8, 2008] 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
establish a program of fees relating to generic new ani-
mal drugs. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE; REFERENCES. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Animal Generic Drug User Fee Act of 2008’’. 
(b) REFERENCES IN ACT.—Except as otherwise speci-
fied, amendments made by this Act to a section or other 
provision of law are amendments to such section or other 
provision of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.). 
SEC. 2. FINDINGS. 
Congress finds as follows: 
(1) Prompt approval of abbreviated applications 
for safe and effective generic new animal drugs will 
reduce animal healthcare costs and promote the well- 
being of animal health and the public health. 
(2) Animal health and the public health will be 
served by making additional funds available for the 
purpose of augmenting the resources of the Food and 
Drug Administration that are devoted to the process 
for the review of abbreviated applications for the ap-
proval of generic new animal drugs. 
(3) The fees authorized by this Act will be dedi-
cated toward expediting the generic new animal drug 
development process and the review of abbreviated ap-
plications for generic new animal drugs, supple-
mental abbreviated applications for generic new ani-
mal drugs, and investigational submissions for ge-
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neric new animal drugs as set forth in the goals iden-
tified in the letters from the Secretary of Health and 
Human Services to the Chairman of the Committee 
on Energy and Commerce of the House of Representa-
tives and the Chairman of the Committee 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 following: 
‘‘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.— 
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‘‘(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 (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 sub-
paragraph (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 abbreviated application which is re-
fused for filing. 
‘‘(E) REFUND
OF
FEE
IF
APPLICATION 
WITHDRAWN.—If an abbreviated application is 
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withdrawn after the application was filed, the 
Secretary may refund the fee or portion of the fee 
paid under subparagraph (B) if no substantial 
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 
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‘‘(3) 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. 
‘‘(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-
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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-
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. 
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‘‘(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-
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.—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 applications 
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 re-
view of abbreviated applications for generic 
new animal 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 en-
gaged in such process) over such costs, ex-
cluding 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 sub-
paragraph (A)(ii) in any fiscal year if the costs 
funded by appropriations and allocated for the 
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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 
‘‘(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). 
‘‘(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; 
as adjusted to reflect adjustments in the total fee reve-
nues made under this section and changes in the total 
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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 2009 through 2011 and the amount of fees 
estimated to be collected under this section for fiscal 
year 2012 exceeds the cumulative amount appro-
priated 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 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 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. 
‘‘(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 
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