graph (1), the fee revenues shall be further ad-
justed each fiscal year after fiscal year 2004’’ 
and inserting ‘‘The fee revenues shall be ad-
justed each fiscal year after fiscal year 2009’’; 
and 
(B) in subparagraph (B), by striking ‘‘, as 
adjusted for inflation under paragraph (1)’’; 
and 
(4) in paragraph (2), as so redesignated— 
(A) by striking ‘‘2008’’ each place it ap-
pears and inserting ‘‘2013’’; and 
(B) by striking ‘‘2009’’ and inserting 
‘‘2014’’. 
(d) AUTHORIZATION
OF
APPROPRIATIONS.—Sub-
paragraphs (A) through (E) of section 740(g)(3) (21 
U.S.C. 379j–12(g)(3)) are amended to read as follows: 
‘‘(A) $15,260,000 for fiscal year 2009; 
‘‘(B) $17,280,000 for fiscal year 2010; 
‘‘(C) $19,448,000 for fiscal year 2011; 
‘‘(D) $21,768,000 for fiscal year 2012; 
and 
‘‘(E) $24,244,000 for fiscal year 2013;’’. 
(e) OFFSET.—Section 740(g)(4) (21 U.S.C. 379j– 
12(g)(4)) is amended to read as follows:
‘‘(4) OFFSET.—If the sum of the cumulative 
amount of fees collected under this section for fiscal 
years 2009 through 2011 and the amount of fees es-
timated 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 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.’’. 
SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Part 4 of subchapter C of chapter VII (21 U.S.C. 
379j–11 et seq.) is amended by inserting after section 740 
the following: 
‘‘SEC. 740A. REAUTHORIZATION; REPORTING REQUIRE-
MENTS. 
‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal 
year 2009, not later than 60 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 concerning the progress 
of the Food and Drug Administration in achieving the 
goals identified in the letters described in section 101(b) 
of the Animal Drug User Fee Amendments of 2008 to-
ward expediting the animal drug development process and 
the review of the new and supplemental animal drug appli-
cations and investigational animal drug submissions dur-
ing such fiscal year, the future plans of the Food and 
Drug Administration for meeting 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 ab-
breviated new animal drug applications are not increased 
from their current level due to activities under the user 
fee program. 
‘‘(b) FISCAL REPORT.—Beginning with fiscal year 
2009, 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 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 the Congress with re-
spect to the goals, and plans for meeting the goals, 
for the process for the review of animal drug appli-
cations for the first 5 fiscal years after fiscal year 
2013, 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; 
‘‘(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 
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, 2013, the Secretary 
shall transmit to the Congress the revised rec-
ommendations under paragraph (4), a summary of 
the views and comments received under such para-
graph, and any changes made to the recommenda-
tions 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 the 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. 105. ANTIMICROBIAL ANIMAL DRUG DISTRIBUTION 
REPORTS. 
(a) REPORTS.—Section 512(l) (21 U.S.C. 360b(l)) is 
amended by adding at the end the following: 
‘‘(3)(A) In the case of each new animal drug de-
scribed in paragraph (1) that contains an antimicrobial 
active ingredient, the sponsor of the drug shall submit an 
annual report to the Secretary on the amount of each anti-
microbial active ingredient in the drug that is sold or dis-
tributed for use in food-producing animals, including in-
formation on any distributor-labeled product. 
‘‘(B) Each report under this paragraph shall specify 
the amount of each antimicrobial active ingredient— 
‘‘(i) by container size, strength, and dosage 
form; 
‘‘(ii) by quantities distributed domestically and 
quantities exported; and 
‘‘(iii) by dosage form, including, for each such 
dosage form, a listing of the target animals, indica-
tions, and production classes that are specified on 
the approved label of the product. 
‘‘(C) Each report under this paragraph shall— 
‘‘(i) be submitted not later than March 31 each 
year; 
‘‘(ii) cover the period of the preceding calendar 
year; and 
‘‘(iii) include separate information for each 
month of such calendar year. 
‘‘(D) The Secretary may share information reported 
under this paragraph with the Antimicrobial Resistance 
Task Force established under section 319E of the Public 
Health Service Act.
‘‘(E) The Secretary shall make summaries of the in-
formation reported under this paragraph publicly avail-
able, except that— 
‘‘(i) the summary data shall be reported by 
antimicrobial class, and no class with fewer than 3 
distinct sponsors of approved applications shall be 
independently reported; and 
‘‘(ii) the data shall be reported in a manner 
consistent with protecting both national security and 
confidential business information.’’. 
(b) FIRST REPORT.—For each new animal drug that 
is subject to the reporting requirement under section 
512(l)(3) of the Federal Food, Drug, and Cosmetic Act, 
as added by subsection (a), and for which an approval of 
an application filed pursuant to section 512(b) or 571 of 
such Act is in effect on the date of the enactment of this 
title, the Secretary of Health and Human Services shall 
require the sponsor of the drug to submit the first report 
under such section 512(l)(3) for the drug not later than 
March 31, 2010. 
(c) SEPARATE REPORT.—The reports required under 
section 512(l)(3) of the Federal Food, Drug, and Cosmetic 
Act, as added by subsection (a), shall be separate from 
periodic drug experience reports that are required under 
section 514.80(b)(4) of title 21, Code of Federal Regula-
tions (as in effect on the date of the enactment of this 
title). 
SEC. 106. SAVINGS CLAUSE. 
Notwithstanding section 5 of the Animal Drug User 
Fee Act of 2003 (21 U.S.C. 379j–11 note), and notwith-
standing the amendments made by this title, part 4 of sub-
chapter 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 title, shall 
continue to be in effect with respect to animal drug appli-
cations and supplemental animal drug applications (as de-
fined in such part as of such day) that on or after Sep-
tember 1, 2003, but before October 1, 2008, were accepted 
by the Food and Drug Administration for filing with re-
spect to assessing and collecting any fee required by such 
part for a fiscal year prior to fiscal year 2009. 
SEC. 107. EFFECTIVE DATE. 
The amendments made by sections 102, 103, and 104 
shall take effect on October 1, 2008, and fees under part 
4 of subchapter 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 supple-
mental animal drug applications received on or after such 
date, regardless of the date of the enactment of this title.
SEC. 108. SUNSET DATES. 
(a) AUTHORIZATION.—The amendments made by 
sections 102 and 103 cease to be effective October 1, 
2013. 
(b) REPORTING REQUIREMENTS.—The amendment 
made by section 104 ceases to be effective January 31, 
2014. 
TITLE II—ANIMAL GENERIC 
DRUG USER FEE 
SEC. 201. SHORT TITLE; FINDINGS. 
(a) SHORT TITLE.—This title may be cited as the 
‘‘Animal Generic Drug User Fee Act of 2008’’. 
(b) 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 approval of generic new animal drugs. 
(3) The fees authorized by this title will be 
dedicated toward expediting the generic new animal 
drug development process and the review of abbre-
viated applications for generic new animal drugs, 
supplemental 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 Chairman 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. 202. 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 
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-
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 
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 
(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. 
‘‘(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-
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). 
‘‘(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. 
‘‘(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 
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 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.—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. 
‘‘(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. 
‘‘(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). 
‘‘(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 
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. 
‘‘(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.
‘‘(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-
curred 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 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.
‘‘(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
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
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.
‘‘(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.’’.
SEC. 203. ACCOUNTABILITY AND REPORTS. 
Part 5 of subchapter C of chapter VII of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379f et seq.), 
as added by section 202, is amended by inserting after 
section 741 the following: 
‘‘SEC. 
742. 
REAUTHORIZATION; 
REPORTING 
REQUIRE-
MENTS. 
‘‘(a) PERFORMANCE REPORTS.—Beginning with fis-
cal year 2009, not later than 60 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 
201(3) of the Animal Generic Drug User Fee Act of 2008 
toward expediting the generic new animal drug develop-
ment process and the review of abbreviated applications 
for generic new animal drugs, supplemental abbreviated 
applications for generic new animal drugs, and investiga-
tional submissions for generic new animal drugs during 
such fiscal year. 
‘‘(b) FISCAL REPORT.—Beginning with fiscal year 
2009, 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 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 
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 2013, 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; 
‘‘(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 
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, 2013, 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
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. 204. SUNSET DATES. 
(a) AUTHORIZATION.—The amendments made by 
section 202 shall cease to be effective October 1, 2013. 
(b) REPORTING REQUIREMENTS.—The amendment 
made by section 203 shall cease to be effective January 
31, 2014.
TITLE III—TECHNICAL 
CORRECTIONS TO FDAAA 
SEC. 301. CONSIDERATION OF CERTAIN PETITIONS. 
Subparagraph (A) of section 505(q)(1) (21 U.S.C. 
355(q)(1)) is amended by adding at the end the following: 
‘‘Consideration of the petition shall be separate 
and apart from review and approval of any ap-
plication.’’. 
SEC. 302. REGISTRY AND RESULTS DATA BANK. 
Paragraph (3) of section 402(j) of the Public Health 
Service Act (42 U.S.C. 282(j)) is amended— 
(1) in the matter preceding clause (i) in sub-
paragraph (C), by striking ‘‘the following elements’’ 
and all that follows through ‘‘520(m) of such Act:’’ 
and inserting ‘‘for each applicable clinical trial for a 
drug that is approved under section 505 of the Fed-
eral Food, Drug, and Cosmetic Act or licensed under 
section 351 of this Act or a device that is cleared 
under section 510(k) of the Federal Food, Drug, 
and Cosmetic Act or approved under section 515 or 
520(m) of such Act, the following elements:’’; and 
(2) in clauses (i) and (iii) of subparagraph (I), 
by striking the term ‘‘drugs described in subpara-
graph (C)’’ each place such term appears and insert-