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80–810 2013

REAUTHORIZATION OF ANIMAL DRUG USER FEES: 

ADUFA AND AGDUFA 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED THIRTEENTH CONGRESS 

FIRST SESSION 

APRIL 9, 2013 

Serial No. 113–25 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

(II) 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

RALPH M. HALL, Texas 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

CORY GARDNER, Colorado 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Missouri 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

FRANK PALLONE, JR., New Jersey 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

BEN RAY LUJAN, New Mexico 

PAUL TONKO, New York 

(III) 

SUBCOMMITTEE ON HEALTH

JOSEPH R. PITTS, Pennsylvania 

Chairman 

MICHAEL C. BURGESS, Texas 

Vice Chairman 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

RENEE L. ELLMERS, North Carolina 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

JOHN D. DINGELL, Michigan 

ELIOT L. ENGEL, New York 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

GENE GREEN, Texas 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

HENRY A. WAXMAN, California (ex officio) 

(V) 

C O N T E N T S 

Page 

Hon. Joseph R. Pitts, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 67 

Prepared statement .......................................................................................... 68 

Hon. Cory Gardner, a Representative in Congress from the State of Colorado, 

opening statement ................................................................................................ 68 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 69 

Hon. Fred Upton, a Representative in Congress from the State of Michigan, 

opening statement ................................................................................................ 70 

Prepared statement .......................................................................................... 71 

Hon. John Shimkus, a Representative in Congress from the State of Illinois, 

opening statement ................................................................................................ 71 

Hon. Henry A. Waxman, a Representative in Congress from the State of 

California, opening statement ............................................................................. 72 

WITNESSES

Bernadette Dunham, Director, Center for Veterinary Medicine, U.S. Food 

and Drug Administration .................................................................................... 74 

Prepared statement .......................................................................................... 77 

Richard A. Carnevale, Vice President, Regulatory, Scientific and International 

Affairs, Animal Health Institute ......................................................................... 103 

Prepared statement .......................................................................................... 106 

Mike Apley, Professor and Section Head, Production Medicine and Clinical 

Pharmacology, College of Veterinary Medicine, Kansas State University ...... 111 

Prepared statement .......................................................................................... 113 

Lance B. Price, Professor, Department of Occupational and Environmental 

Health, George Washington University ............................................................. 123 

Prepared statement .......................................................................................... 125 

SUBMITTED MATERIAL

Discussion drafts 

ADUFA .............................................................................................................. 2 

AGDUFA ........................................................................................................... 38 

Letter of April 5, 2013, from medical coalition to the Committee, submitted 

by Mr. Waxman .................................................................................................... 142 

Letter of April 5, 2013, from medical and scientific organizations to the 

Committee, submitted by Mr. Waxman ............................................................. 145 

Letter of April 2, 2013, from the Patient, Consumer, and Public Health 

Coalition to the Committee, submitted by Mr. Waxman .................................. 148 

Letter of April 24, 2013, from the the Food and Drug Administration to 

the subcommittee, submitted by Mr. Pitts ......................................................... 150 

(1) 

REAUTHORIZATION OF ANIMAL DRUG USER 

FEES: ADUFA AND AGDUFA 

TUESDAY, APRIL 9, 2013 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON HEALTH, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The subcommittee met, pursuant to call, at 4 p.m., in room 2123, 

Rayburn House Office Building, Hon. Joseph R. Pitts (chairman of 

the subcommittee) presiding. 

Present: Representatives Pitts, Burgess, Shimkus, Gingrey, 

Lance, Guthrie, Griffith, Ellmers, Upton (ex officio), Pallone, 

Capps, Green, Barrow, Christensen, Waxman (ex officio). 

Also present: Representative Gardner. 

Staff Present: Clay Alspach, Chief Counsel, Health; Gary Andres, 

Staff Director; Matt Bravo, Professional Staff Member; Sydne 

Harwick, Legislative Clerk; Robert Horne, Professional Staff Member, Health; Carly McWilliams, Professional Staff Member, Health; 

John O’Shea, Professional Staff Member, Health; Andrew 

Powaleny, Deputy Press Secretary; Chris Sarley, Policy Coordinator, Environment and Economy; Heidi Stirrup, Health Policy Coordinator; Tom Wilbur, Digital Media Advisor; Alli Corr, Minority 

Policy Analyst; Eric Flamm, Minority FDA Detailee; Karen Lightfoot, Minority Communications Director and Senior Policy Advisor; 

Karen Nelson, Minority Deputy Committee Staff Director for 

Health; and Rachel Sher, Minority Senior Counsel. 

Mr. PITTS. Time of 4 o’clock having arrived, this subcommittee 

will come to order. The chair will recognize himself for an opening 

statement. 

Today’s hearing focuses on the reauthorization of two successful 

programs, the Animal Drug User Fee Act, ADUFA, and the Animal 

Generic Drug User Fee Act, AGDUFA. 

[The bills follow:] 

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113TH CO:--JGRESS 

1ST SESSIOX 

(Original Signatur(' of l'Iemhpr) 

H.R. 

To amend the Federal Food, Drug, and Cosmetic Act to reauthorize user 

fee programs J'elatillg to new animal drugs. 

IN" THE HOUSE OF REPRESEN"TATIVES 

Mr. SHlMKrs introduced the following bill: whidl was referred to the 

Committee on .......... _________ .. _ ...... _. __ 

A BILL 

To amend the Federal Food, Dmg, and Cosmetic Act to 

reauthorize user fee programs relating to new animal dmgs. 

Be it enacted by the Senate and IIouse of Representa2 t£ves of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; FINDING. 

4 (a) SHORT TITLE.-This Act may be cited as the 

5 ""'lllimal Drug User Fee Amendments of 2013". 

6 (b) FrxDIxG.-Congress finds that the fees author7 ized by the amendments made in this Act ,\111 be dedicated 

8 toward eA'})editing the animal dmg development process 

9 and the rm1ew of new and supplemental animal dmg apfWHLC\040213\040213.116.xml 

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1 plication." and investigational animal drug submissions as 

2 set forth in the goals identified, for purposes of part 4 

3 of subchapter C of chapter ,,11 of the Federal Food, Drug, 

4 and Cosmetic Act, in the letters from the Secretary of 

5 Health and Human Services to the Chairman of the Com6 mittee on Energy and Commerce of the House of Rep7 resentatives and the Chairman of the Committee on 

8 Health, Education, Labor, and Pensions of the Senate as 

9 set forth in the Congressional Record. 

10 SEC. 2. DEFINITIONS. 

11 Section 739 of the Federal Food, Drug, and Cosmetic 

12 Act (21 U.S.C. 379j-ll) is amended to read as follows: 

13 "SEC. 739. DEFINITIONS. 

14 "For purposes ofthis part: 

15 "(1) The term 'animal drug application' means 

16 an application foJ' approval of any new animal drug 

17 submitted under section 512 (b ) (1 ). Such term does 

18 not include either a new animal drug application 

19 submitted under section 512(b)(2) or a supplemental 

20 animal drug application. 

21 "(2) The term 'supplemental animal drug appli22 cation' means23 "(A) a request to the Secretary to approve 

24 a change in an animal drug application which 

25 has been approved; or 

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1 "(B) a request to the Secretary to approye 

2 a change to an application approved under sec3 tion 512(c)(2) for 'which data with respect to 

4 safety or effectiveness are required. 

5 "(3) The term 'animal drug product' means 

6 each specific strength or potency of a particular ac7 tive in6'Tedient or ingredients in final dosage form 

8 marketed by a particular manufacturer or dis9 tributor, which is uniquely identified by the labeler 

10 code and product code portions of the national drug 

11 code, and for which an animal drug application or 

12 a supplemental animal drug application has been ap13 proved. 

14 "( 4) The term 'animal drug establishment' 

15 means a foreign or domestic place of business which 

16 is at one general physical location consisting of one 

17 or more buildings all of which are within 5 miles of 

18 each other, at which one or more animal drug prod19 ucts are manufactured in final dosage form. 

20 "(5) The term 'investigational animal drug sub21 mission' means22 "(A) the filing of a claim for an investiga23 tiona1 exemption under section 512(j) for a new 

24 animal drug intended to be the subject of an 

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animal ch'ug application or a supplemental alll2 mal drug application; or 

3 "(B) the submission of information for the 

4 purpose of enabling the Secretary to evaluate 

5 the safety or effectiveness of an animal drug 

6 application or supplemental animal drug appli7 cation in the ewmt of their filing. 

8 "(6) The term 'animal drug sponsor' means ei9 ther an applicant named in an animal drug applica10 tio11 that has not been ,vithdrmvn by the applicant 

11 and for which approval has not been ,,'ithdrawn by 

12 the Secretary, or a person ,vho has submitted an in13 vestigational animal drug submission that has not 

14 been terminated or othen,'ise rendered inactive by 

15 the Secretary. 

16 "(7) The term 'final dosage form' means, with 

17 respect to an animal drug product, a finished dosage 

18 form which is approved for administration to an ani19 mal without substantial further manufacturing. Such 

20 term ineludes animal (kug products intended for 

21 mixing in animal feeds. 

22 "(8) The term 'process for the rev'iew of animal 

23 drug applications' means the follO\\'ing' acti,'ities of 

24 the Secretary ,,'ith respect to the review of animal 

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1 (mIg applications, supplemental animal drug applica2 tions, and investigational animal drug submissions: 

3 "(A) The activities necessary for the re4 view of animal drug applications, supplemental 

5 animal drug applications, and investigational 

6 animal drug submissions. 

7 "(B) The issuance of action letters \vhieh 

8 approve animal drug' applications or supple9 mental animal drug applieations or ,yhieh set 

10 forth in detail the specific deficiencies in animal 

11 drug applications, supplemental animal dl1lg 

12 applications, or investigational animal drug sub13 missions and, where appropriate, the actions 

14 necessary to place such applications, supple15 ments, or submissions in eondition for approval. 

16 "(C) The inspeetion of animal dl1lg estab17 lishments and other facilities undertaken as 

18 part of the Secretary's review of pending animal 

19 dl1lg applications, supplemental animal drug 

20 applications, and investigational animal drug 

21 submissions. 

22 "(D) Monitoring of researeh conducted in 

23 eonnection with the review of animal dl1lg ap24 plications, supplemental animal dl1lg applicaf:WHLCI0402131040213.116.xml (54364217) 

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tions, and investigational animal drug submis2 sions. 

3 "(E) The development of regulations and 

4 policy related to the review of animal drug ap5 plications, supplemental animal drug applica6 tions, and investigational animal drug submis7 sions. 

8 "(F) Development of standards for prod9 ucts subject to review. 

10 "( G) Meetings between the agency and the 

11 animal drug sponsor. 

12 "(H) Reyiew of adYertising and labeling 

13 prior to approval of an animal drug application 

14 or supplemental animal drug application, but 

15 not after such application has been approved. 

16 "(9) The term 'costs of resources allocated for 

17 the process for the review of animal drug applica18 tions' means the e:l.llenses in connection ,,,;th the 

19 process for the review of animal drug applications 

20 for21 "(A) officers and employees of the Food 

22 and Drug Administration, contractors of the 

23 Food and Drug Administration, advisory com24 mittees consulted ,,;th respect to the nwiew of 

25 specific animal drug applications, supplemental 

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lmill1Hl d!'llg' applications, or illY('stig'ational Hnimal drug suhmissiolls. and eosts l'('iaied to sHell 

tors, ineludillg' ('osts for tn1\'('l, education. mul 

l'ceruitnwllt and oth('r personnel adi\-ities; 

manag'ement of iuformation and the 

(\eqnisitioll, mailltl'llmwe, and repair of eOlllputer reSOllr('('S; 

leasing', ll1ailltemmee, l'('110Yatioll. aud 

repair of faeilities ,wd aeCjuisitioll, maintemme('. 

ami repair of fixtures. furniture, seientifie 

12 equipment, and other lleeeSSal',\- materials and 

13 supplies; and 

14 "(1)) eolleetillg' fees under seetion 7-W and 

15 (lC'('mUltillg for ]'('son1'('es alloeated for the re16 yiF\Y of animal drug' applieatiol1s, snpplemental 

17 animal drug' applications, and ill\'('stigatiollal 

18 anima 1 drug- submissiOllS. 

19 "(10) 'rIll' term 'adjustmellt fnC'tor' applieahle 

20 to a risenl year refers to the formnla set forth ill SP('-

21 tion \"jth th{' hasp or comparator month 

22 being O('to])('1' 2002. 

23 "(11) Tbe term 'person' inelndes all affiliah' 

24 then'of. 

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"(1:::) The tt'rm 'aftlliate' rd'el's to the defilli2 tion set forth in sed ion 7:36(11),". 

3 SEC. 3. AUTHORITY TO ASSESS AND USE ANIMAL DRUG 

4 FEES. 

5 Sedioll 740 of the Fe(ieral Food, Dl11~, alld Cosmetie 

6 Ad (21 r.s.c. ;379j~12) is mneuded to rl'ad as follows: 

7 "SEC. 740. AUTHORITY TO ASSESS AND USE ANIMAL DRUG 

8 

9 

FEES. 

TYPES OF FEE8.-Be~iJmill~ in fiseal year 

10 2004, tIll' S('('r('tar~- shaH ass('ss and tolleet rl'PS ill aeeon1-

11 ,mel' with this s,·('tion as follmys: 

12 "(1) A~L\IAL mW(l ,\PPLICATIO~ ),~D 81TI'LE13 ~m~T FEE.-

14 I~ m:~ERAL.-Ea('h p(,I'son that sub15 mits, on or aftt'l' S('pt('mlw1' 1, 200:i, ,m animal 

16 drug HpplieatioH or a supplemental animal drug 

17 applieatioll shall hi' subjeet to a fee as follows: 

18 "(i) A f('e established ill snbseetiol1 (e) 

19 for nn animH 1 drug applieatioll, exeept all 

20 animal drug l1pplieatioll des('ribed in see21 tiOll 61:::(<1)(4). 

22 "(ii) A fee established ill s'ubsoetloll 

23 (e), ill an amount that is equal to 50 per24 eellt of th(, anlOunt of the fee ullder elanse 

25 (i), fo1'-

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"(I) a supplemental ullimal drug 

appliention for whic'h safety Of' c'ffeetin'lless data are n·quil'ed; mHl 

"(II) an animal dl'1lg applieatioll 

deseribed in s('e(ion 512(d)(4). 

P,\DIK:\T.-Tlw fee required hy suhparagraph (A) shall be due UpOll submission of 

the allimal drng npplieation or supplemental 

allimal drug' applieation. 

EXCEPTIO:\ FO!{ PHEYIOFSLY FILED 

drng applic'ation or a SllpplelllC'lltal animal drug' 

applieatioll \\"as submitted by a person that paid 

the fee for sueli applieatiou or supplement, ,,,as 

nC'('('pted for filing', and was Hot app]'oYed or 

was withdrmnl (\\ithout a ,Yaiy('[' or refund), 

the submission of an allimal drug' applieatioll or 

H snpph'mental animal drug' Dpplieatioll for the 

smm' pl'oduet b,\' the sam(' ])('l'SOll (01' the p('rson's li(,l'llSl'l', or sne('essol') shall not 

he sllbj(·ct to a fee uuder subparagraph (J\.). 

"(D) REFF:\D elI<' FBE Ib' Al'PLICA'l'lO:'\ REFFSED FOIl FILl:\(l.--The Seeretar." shall refund 75 pereent of tIw fee paid under snbpamg'raph (B) for all." animal drug appli{'atioll OJ' 

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supplellwntai anilllal drug' applieatiol! whith lS 

]'C'fu:-K'd fo!' filing. 

\yITIlDRA\\~:'\.-If an animal dmg applieatioll 01' 

n snpplenwutal animal <lmg applitatioll is ,,-itlldrmnl aftl'r the applieatloll or supplenwllt was 

filed, the Seel'etar:,-- nmy refund the fee 01' POI'-

tiOll of the fee paid uuder subparag'raph (B) if 

no substantial ,york ,,,as ]wrformed on the appli{'atioll or su pplemellt after the applieatioll or 

supplement ,yas filed. The Seerc'hu'~- shall baw 

the SOIl' diseretioll to refund the fee Ulllkl' this 

pm·agraph. A tI('termination by the S('el'etal',v 

eoneeT'ning a refund Huder this paragruph shall 

Hot be reyiewahk. 

"(2) A:,\LlIAL Dln:o PBODtTT FEE.-

"(i) \yl1o is named as the applieant in 

(lJi animal drug- npplif'atioll or sllpplelW'lltal animal lh'ug' applicatiou for an Hnilllal (lrug pro<1uet which has beell snbmltted for listing' under seeiiou 510j and 

who, after September 1, 2003. 

had llL'lHling' before the Se('rl'tal'.'~ an Hlll-

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mal dntg' applir·ntioll or supplemental Hll!-

mal dl11g' applieation, 

shall 1)}1~- fOl' eaeh suell animal dmg p1'o<111('t the 

Hll1Hlal fee established ill sllbs('etion (e). 

shall h(' payable for tlie fiseal ~'ear in w11ieh the 

animal drug' ])1'o(1uet is first snbmittt'd for jistiug ullder set'tioll 510, 01' is submitted fof' relisting nuder seetion 510 if the allimal drug 

jll'odud has lwcn withdrawn from listing and 

r('listed. After snell fl'e is paid for that fis('al 

.\'e<1I'. suell fe'\' shall he dne eaeh subsequent fiseal year that the PI'Odlld remains listed, upon 

tll(' later 01'-

"(i) tIll' fiest husiness da~- after' tl1(' 

date of enaetnwut of an appropriatiolls Aet 

proyidillg' for the ('oll('etioll and oblig'atioll 

of fc'('s for suth fisenl year unde!' this section; or 

.Januar~- 81 of eac·h ~'('Hr. 

"(C) IJLIIlTATIOX.-Sueh fee shall he paid 

only 0])('(' for ('Hell animal drug' produet for a 

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\'dm O\nl" 01' OjJPl'atcs, dil'edly OJ' 

through an affiliah" an animal dnlg ('stnhlislUlll'llt; 

who is mmll'd as tlw applicant ill 

an animal (lrug application or supplellll'lltal animal dl'1lg applieatioll for an animal drug product whieh has l)(,Cll s11hmittel] for listing nnde]' seetioll 510; and 

,yho, after St'ptemht'l' 1, 2008, 

had pC'Helillg 1wfo]'(' tlw Se(,l'etm'~- an alllmal drug' applieation or snpplemental animnl (b'llg' npplieatioll, 

shnll he assessed all HllllUal ('stablisllIUPllt fc'l' as 

established ill suhsc,etio!l (e) for eHell animal 

dl'1lg establishment listed ill its approwd animal 

dl'11g: applieatioll as all ('stublishmellt that manufne-turl's til(' animal drug produet nallwd ill the 

applieatioll. 

"(B) PADlE:\T; j"E\<J on] DATE.-The Hllnual establishment fee shall be ass{'ss(·(j in eHell 

fiseal year ill whieh the <1l1imal drug pl'()(hwt 

named ill the ap]llieatioll is ass('ssed a fC'(' uIlder 

uull's!'; the auimal dJ'Ug establish111(']1t listed in the applieatioll clot's not ellg'age 

ill tIl(' manufaetnre of the <lllimaJ dmg prodnd 

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dUl'illg' the fiseal ~~eal'. TIlt' fee unde]' this paragraph for a fiscal ,war shall be due UPOll the 

latl·], 01'-

i Ill' first ImsinC'ss <1a:>, after till' 

datl' of cum'tment of all appropriatiolls Ad 

pJ'o\iding for the eolleetioll awl obligation 

of f('es for snell fisenl year uuder this seetion; or 

"(ii) .Janua]':>,:31 of cneh year. 

"(C) LJ:lJITA'l'IO);.-

d(i) I); GE:-\EHAL.-All ('stablishment 

shall b(, assessed olll~- Oll(' f{'c per fiscal 

year undcr this section, Sllbjl·et to dans(' 

11 Sillgk estnhlislnnent llUlllufactul'es both 

animal drug prodnets and pn'sC'l'iptioll 

S11th establishmeut shall 1)(' assess('(l both the aniwal dnlg establishmC'ut 

fee and the preseriptioll drng' estahlishmellt as set forth ill s('etion 78(5(a)(2)' 

witbin a sillgle fiseal year. 

''CA.) I); m::xI~!L\L.-Ea('h pel'SOIl-

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15 


80810.053

F:\M 13\SHIMKU\SHlMK U_002.xML 

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l-l: 

"(i) who meets tbe \lefillitioll of an 

allimal drug sponsor ,yithill a fisenl year; 

and 

,.1'110. after September 1, 2008, 

had pemling before the Set'1'l'htry all allilUal dmg applieatioll, a snpplC'l1wl1tal Hl1llIlal dl11g applieatioll, or an inwstigatiollal 

animal drug submissic)]l, 

shall lw assessed an annllal sponsor fee as established uuder sllhsl'dioll (e). 

PAY:\IEXT; FEE Dn~ DATE.-The fee 

ullder this paragraph fm' a fisc-al year shall he 

due upon the later of'--

dnte of ellaetlllent of an appropriations Aet 

pro,-iciillg' for 11w eolleetioll and ohligatioll 

of fees for s11('11 fisenl ,war under this seetim); 01' 

,Jannary 81 of eaeh ,\'('a1' , 

LL\JlTATlOX.-Eaeh animal drug' 

21 sponsor shall pay ollly O1W s1Ieh fee l'Hell fiseal 

22 year. 

23 "(b) FEE HEYEXCE A:\10l'XT8,-

24 Ix CExERAL.-Snl\l('e! to snbs('etlol1s «('), 

25 (<1), (fl, alld 

f:WHLC\040213\040213.116.xml (54364217) 

April 2. 2013 (5:14 p.m.) 
16 


80810.054

F:IM13ISH1MKUISHIMKU_002XML 

Iii 

foJ' fiseal ~'('ar 2014-, til{' fues required 

2 lmriUl' snbs('etion (n) shall bu establislll'd to gC'll3 l'1'at(' 11 total j'cycnue a11101111t of $2:1,()OO,OOO; 

4 and 

5 "(B) for eaeh of fise(11 ~'('al's 201ii through 

6 2018, the fees n'qllil'ed mrdel' suhs('etioll (11) 

7 shall be established to generate a total l'('Wllue 

8 amonnt of $21,600,000. 

9 TYPES OF FEES.-Of tlll' total reWlllW 

10 amount detemrllll'd fot' a fiseal ~'ear Ululer para11 graph 

12 20 perel'llt shall be (lelin~d from fees 

13 mule!' subseetioll (a)(1) (relating to allimal 

14 applientions and supplements); 

15 "(B) 27 pereent shall be deriycd from fees 

16 lI11der subscetioll (a)(2) (relating' to animal 

17 prodm·ts); 

18 2G 1)('I'e('nt shal! 1)(' deriypc1 from f(·(>s 

19 

20 

21 

22 

23 

24 

f:IVHlCI040213\040213.116.xml 

April 2. 2013 (5:14 p.m.) 

until>!' suhseetion (a)(il) (n;latillg' to animal 

drug' l'stahlisllllwnts); amI 

"(D) 27 pCJ'C'ent shall be dcriy('d from fpc's 

under snhscdiotl (relati1lg' to animal 

dmg sponsors). 

An,Jl'ST:\IEC\'TS.-

(54364217) 
17 


80810.055

F:\M13\SHIMKu\SHIMKU_002X\1L 

IG 

2 shall t;stnhlish. GO day" before the start of ('(jcll fis3 clll ;,e(1]' lwgil111illg aft('[' Reph'ml)('l' 80, 200:3, for 

4 that fisen] ~-ear, animal dl1lg' applieatioll f('l's, sup5 ph'mentnl animal drug' npplieution fpes, animal drug 

6 spOllsor animal drug estahlishment and 

7 animal (lmg IH'odnd ft'es based on tl1(' reY('mw 

8 amounts established nnder subseetion (h) HlHI llu' 

9 a(tillst llIC'uts p!,(rllr1ed uuder this snbseetion, 

10 IXFL),TIOX AD.H'S'J':\JExT.-For fisen] year 

11 201:) and snbseqlwnt tlseni years, the n'\,('llUe 

12 alllounts ('stabli"lH'tl in subseetioll (h) shall lw a(l13 jm:t\,d b~- the Seerdal'Y br notie(" publislll'd in the 

14 Federal Heglstcl" for a fisenl ~-car', by an 1l111Olmt 

15 equal to the sum of16 011C'; 

17 "(B) the HWl'age annual perc-ent elmnge in 

18 the eost, pel' full-timp ('qul,-alellt position of the 

19 Food and. Drng A(liniuistl'ation, of alljwl'solllwi 

20 eOlll]lC'llsation Hlltl bpuefits paid \rit11 resped to 

21 su('h positions fbI' the 6rst :3 of the j)l'c(,l'dillg 

22 4- fiseal years for whieh data are (1\-£1ilah1e, nm1-

23 tiplil'd b:-- the awrage proportio11 of IwrsOlmd 

24 eompensatioll Hwl l)(,llefits eosis to totnl Food 

25 a]](1 Drug Admiuistratioll ('osts for the first a 

f:WHLC\040213\040213.116.xml 

April 2, 2013 (5:14 p.m.) 

(54364217) 
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80810.056

F:\M 13\SHIMKU\SHIMKU._002,XML 

17 

2 data arc cwailahk'; and 

3 "(C) the aYl'rag-e annual pereent ehange 

4 that o('enrred in the COllsmnt'l' PriN' Index fot' 

5 urball eOllSUllWl'S (Washingtoll-Baltimore, DC6 :\rD-YA-'\Y; ]]ot s('asOlHlll~- m\jnsted; all items 

7 less food and energy; aIlllual itHkx) for th,' fil'St 

9 are ayailable mnitipii('d by tht' <lwl'ngt' propor10 tiOll of all costs other than IWl'Sonnel eOl1ljx'llsa11 tiot! and benefits ('osts to total Food and Drug12 Admillistration eosts for the first :i years of the 

13 preet'(iing- -t fiseal years for ,ybieh data nre 

14 uYHilable, 

15 The H(1instmeut made ('Hell fiseal ~-('al' 111lder 1his 

16 ImragT<lph shall he added on a ('ol1lpoundecl basis to 

17 the smn of aU mljusiments made eaeh fist'nl ,war 

18 aftpj' fisc-al ~-('''l' 2014 llJl(kl' this pnragTHph. 

19 "(:3) WOHKLOAD .\D,n'sT:\!K:\T.-Fo)' fisenl 

20 ,war 201;) and subsequellt fiseal ~-l'ars, after tIl(' l'ey21 l']nw amounts estnhlis]wd ill subseetioll (b) ar(' ad22 jnsted for int1atioll in aeeordanee with paragraph 

23 Ow ]'('Y('IHW amollnts sha 11 1)(' fnrtlwr (l(ljllsted 

24 for snell fisenl ;war to l'et1eet ehaug't's in the work25 load of the Se('retHr~' foe the ])l'OC'l'Sfl for the I'('yt('\Y 

fWHLC\040213\040213.116.xml 

April 2, 2013 (5:14 p.m.) 

(54364217) 
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80810.057

F:\M13\SHIMKu\SHIMKD_OO2.XML 

1H 

1 of Hnimal dmp: HppliNl1l0llS. 'Yitlt I'C'Njwd to NuC'h 

2 adjustmcllt3 snc'h HC\jnstll1C'nt shall be determined 

5 of the eltange in tIl(' total number of animal 

6 drug applipatiolls, NuppleuH'lltul animal drng 

7 Hpplieatiolls for 'whiel1 data with r('s]1eet to safe8 t,\' or pffceti'n'lwss an~ required, manufacturing' 

9 supplemental animal \Img applieatiolls, illY(,S10 tigational animal dmg stud;' submissions, and 

11 illn'stigatiollal animal drug protoeol snbmis12 sieHls suhmitted to tlw Seer-dar,"; 

13 "(B) the S('erdary Nhall publish III the 

14 Pedeml Register thc' fees resulting' from sneh 

15 adjustment aJl(1 the supporting methodologies; 

16 a UtI 

17 "(e) ullder llO eil'('ulllstaJll'l'S shall SHell ad18 justmellt result in fee reyennes for a fisenl .wnr 

19 that arc leRI') than the fee rewmws for tllat fis20 en1 ~-('ar estahlished ill subse('tiOlI (b), as nei21 justed for inf:1ation under paragTaph (2). 

22 li'I:\AL n~AH AD.n:l'i'nm:\T,-li'or fisenl 

23 ~'('ar 201R, the SeC'1'etal':'" may, in addition to other 

24 H<\justnwuts under this snhset'tioll, further inc1'e(1s(' 

25 the fee'S un de!' tllis section, if s11('ll an Hdjustlll('llt is 

f:WHLC\040213\040213.116.xml 

April 2. 2013 (5:14 p.m.) 

(54364217) 
20 


80810.058

F:\MI3\SHlMKu\SHIMKU_002.xML 

19 

l1('(,(,SSal)' to J)j'oyidc f()l' up to :3 months of operating' 

2 I'esC'l'n's of e(1n)'O\'('1' user fel's for the prm'l'SS for 

3 the l'l'yil',Y of animal drug applieations for the first 

4 :3 months of fiseal ~'('al' 20Hl. If the Foml and Drug 

5 Administration has (,lU'l)'OWr bahml'~'s for the pro('-

6 ('f;S for th,' l'l'\1C'W of kmimaJ dl1lg npplieatiolls in l'X7 ('('ss of :J months of :meh operatillg ['('Sl'ITeS, then 

8 this H(\jnstment ,,,ill not be made. If this adjustment 

9 is lle{'('Ssar.'-, thell the rntiollale for the amount of 

10 the illCreaS(' shall he C'OlltaiIwd in the annual J}otiee 

11 setting fees for fisea] Y\'Hr 2018, 

12 LDlIT.-The totHI amount of fees eharged, 

13 as ndjusted ulHkl' this slliJS('C'tion, for a fiseal year 

14 ma~- !lot ex('ced the total eosts for snell fiseal ,year 

15 for th" I'('SOUl'C'CS allo('uterl for the pro('.ess for tlw re16 yjew of animal dI11g appli('atiol1s. 

18 "(1) I:\ GE:\ERAL.-The S('('retm)' shall gn1lJt a 

19 'YHi"er from or a l'nhwtioll of OIl(' 0]' moJ'(' fpt's as20 

21 finds thnt22 the asseSSlll('nt of the fpt' \\'ould 

23 present a sigllifielUll barrier to illllOYatiol1 be24 eanse of limited reSOlll'C(,S HI'ailahle to sueh per25 SOll or other eil'C'llJ11stmw('s; 

f:IVHLCI0402131040213.116.xml 

April 2. 2013 (5:14 p.m.) 

(54364217) 
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80810.059

F:\M 131SHlMKUISHIMK U _.OO2.XML 

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f:\vHLC\040213\040213,116.xml 

April 2, 2013 (5:14 p.m.) 

:20 

"(B) the fees to be paid by such person 

,,,ill exeeed the cmtil'ipated P1'C';;C'11t Ill1d fntu]'(' 

('osts ineulTed by tIl(' SC'erC'tmT in cOllduetillg 

till' ]H'O('ess for the l'('yiew of animal drug Cl]Jplieatiolls for suell persoll; 

"(C) the Hui1llal drug' applieation or suppll'l1lPlltal animal drug applieation is i11t(,lH1e<1 

sold~' to pl'oyi(1e fol' UI':l' of the animal drug 

111-

"(i) a T~l)C B llw(lieated feed (al': defined III I':edioll 5~)8,a(b)( 8) of title 

Code of Federal Regl11atiolll': (oJ' allY sueeeSSOl' regl11ation)) illtpllded for use in the 

mHllufaetul'c of T,\-pe C frec-ehoiee ll1edifeed defined in seetion 55tU(h)(4) of 

title 21, COlk of Fr>del'a! Hegl1!atiol1s (or 

nn~' sneel'SSOJ' regulation)); 

"(D) thp anima! dmg applieation Ol' snpplellleutal allimal (lrug applieatioll is intended 

solel~' to prOliclp for a minor use or minor S]l('-

('ies inc1ieation; 01' 

(54364217) 
22 


80810.060

!':IM13ISHIMKUlSHlMKU_002.KML 

31 

"( E) the sponsor iuyojYl'd is a small busi2 I1('SS suhmitting' its first animal drug' appliea4 FSE (W STAXIURD ('08T8.-1u making the 

5 finding in parngraph (1)(13), the S(,(,l'('tar~- ma,', 11';(' 

6 standard eosts. 

8 DEFIXITIOX.-1n paragraph (l)(E), 

9 the term 'small Imsilll'ss' meallS an elltjt~- that 

10 Ims fe,wI' than ;')00 employees, including em11 ployces of affiliates. 

12 "(B) WAIYEH (W APPLlcxnox FEE.-The 

14 tIl<' application fee for the first allimal drng ap15 plieatioll that a smalt business or its affiliate 

16 submits to the Seeretm:-- for ],('yll'"lY. After 11 

17 small business or its affiliatt' is granted suell a 

18 \Y<lin'!', tIl(' slllall husiness or its nffijiatp shall 

19 pa~- applieatioll fpes for all subsequent animal 

20 

21 

22 

23 

24 

f:WHLC\040213\040213.116.xml 

April 2. 2013 (5:14 p.m.) 

drug appliealiol1s awl supplemental animal 

(lrug applieatiolls for whieh safety 01' effeetiwness data are' l'e'qui]'('(l in the same manner as 

an t'utit,\- that elm's llot qnali~\- as a small Imsi11('''S. 

(54364217) 
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80810.061

F:\M13\SHIMKU\SHIMKU_002.XML 

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"(C) CERTlFI(,ATlO:'\.-The 8c('I'('ta1'Y shall 

2 require all;' perSOll ,'rho applies for 11 l\'ai\'c1' 

3 uudcr paragraph to c('rtify thl'iT' qmtli4 fic-ation for tJw mlin,1'. The S('el'l'hlr~- shall peri5 odieall~' publish in the Fl'<jpral Hegistl'r a list of 

6 pl'rsons making such (,prtifieatiolls. 

7 "(e) EFFECT OF FAILnm To PAY FEES.-An ani8 mal drug application or supplel1wutal animal drug appliea9 tiOll submitted b~' a person subjc,C't to fees ul1(kr snh10 seC'lion (11) shall he ('onsidered illeOIllplete aud shall not 

11 be aceeptc,d for filing by the 8ee]'etm)- until all fe('s mn:d 

12 h." snell person haY(' been paid. An inyestigational Hnimal 

13 drug submission unde]' sl'etiotl 78H(0)(B) that is sub14 mitted by a person su1lject to fees under subsection (a) 

15 shall be eonsidel'ed illeUlllplete and shall Hot lw ac('eptecl 

17 person haw beell paid. Thc' Sp('I'etaI)' ma~' diseolltillu(~ re18 ,-il'W of' all~' <lninw] dl'll~ npplieatioll, supp10nwlttnl animal 

19 drug' applieation, or inYestigational animal (lJ'ug sulnnis20 8ion from It pel'SOIl if sneh perSOll bas not submitted for 

21 payment all reps ()\\Td lUlder this sed ion b~' :iO da~'s arter 

22 tll(' dati' npon ",hieh t1H'Y are rIlW. 

24 "(1) LLllITATIO:'\.-F(·es ma~- not he assesspd 

25 under suhSf'etioll (a) for a fispul .'-ear begilllling after 

f:IVHlC\0402131040213.116.xml 

April 2. 2013 (5:14 p.m.) 

(54364217) 
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80810.062

F:\M13\SHIMKu\SHTMKU_OO2.XML 

fist'al ~'('al' 20m) Hnless appropriations for salaries 

2 and ('xlwllses of the Fooa Hud Drug' Administratioll 

3 for such fiscal year (exeluding' the amount of fees 

4 appropriated for sneh 1'is('n1 year) an' equal to 01' 

5 greater ilum tllP amount of appropriations for the 

6 salaries and expenses of the Food and Drug Admin, 

7 istratioll for the fiseal ~'('ar 200:3 (exduding the 

8 amount of feel'; appropriated for sHeh fiseal year) 

9 multiplied h~' the m1jnstnlC'nt 1'(letol' applieahle to the 

10 fiseal year illYoln'd. 

11 ArTIIOl{ITY.-If the S()eretm:-' does Hot 

12 asl';('SS fees under suhseetion (n) duriug any portion 

13 of a fiseaJ :n'al' beeanse of paragrnph (1) Hnd if at 

14 a later date in such fisenl ~'CHl' tIll' SCC'l'etm:,,' mayas, 

15 spss suell the Secn:tary may as:,;ess and coIled 

16 snch witllOut nny l1lodifieation in the rate, for 

17 animal drug' applieations, suppkmentnl animal (Img 

18 upplieaiiolls, illH'stigational anilllal drug snbmis19 SiOllS, animal sponsors, animal drug establish20 ments, and animal drug pl'odneis at any time in 

21 sueh fiseal :\'('<11' Hotyrithstalldillg the rn'oyisiollS of 

22 snbseetioll ]'dnting to the date fees are to be 

23 pai<1. 

24 "(g) Cm~DITL'\U A:\D A\'.\llLc\BlLITY OF FEE8.-

f:\VHLCI0402131040213.116.xmi (54364217) 

April 2. 2013 (5:14 p.m.) 
25 


80810.063

F:IM13ISHIMKu\SHIMKU_OO2.XML 

"( 1) 1:\ UE:\EltAL.-Snbjpe! to paragraph 

2 (2)(C), fees authorized UYHll'I' subsectioll (n) shall hl: 

3 eolleetpd and Hynilahle for obligation only to the ex4 tent and in the amount prc)\ided in adnmee in ap5 propriatiolls ,Ads. Snell fl'l's an' authorized to he <1p6 proj)riated to ]"l'111a111 HHlilable nntil expendel1. Sueh 

7 sums as ma,\- be m'(,(,SS<11",\- t1W,\- he transferred from 

8 tIl(' Food and Dru~r J:\rlmillistrntioll salaries and ex9 penses appropriation aeeount ,,-ithont fi;wal ,\-ea1' lim10 itation to SHell appropriation 1\eeount for salary and 

11 expenses vrith sneh fisenl year limitation. The SUlllS 

12 tnlllsfl'lTed shall he <1yailable sold:- for the proeess 

13 for the H'\'ic\Y of allimal drug applieatiollS. 

14 COLLECTIO:\S A,\D APPltOPRL\.TIO:\ 

15 ),J'T8.-

16 "(A) 1:\ GE:\ERA1,.-Tl](' f!'('s authorized 

17 h.'- this S('etloll18 "(i) subject to 8uhparagTnpb (C), shall 

19 be eolket\'d and m-ailabJe 1Jl ('<1eh Eiseal 

20 

21 

22 

23 

24 

25 

f:WHLC\040213\040213.116.xml 

April 2, 2013 (5:14 p.m.) 

mummt s]Jeeii'ied ill appropriation Acts, or 

otlwnrise made' Hynilnble for obligatioll fOr" 

snell fi"tal .'-ear; and 

"(ii) "hall be <Tmilahle to defray inencases in the eosts of the ref;Olll'C'l'S allo-

(54364217) 
26 


80810.064

F:\M13\SHIMKu\SHIMKU_002XML 

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fWHLC\040213\040213.116.xml 

April 2, 2013 (5:14 p.m.) 

').- -,j 

eatC'd for the proeess fol' the' l'('"ie\Y of Hni111<11 drug Hpp1ieaiiolls (illeluding im'reases 

ill sueh ('osts for an c\(1diiional mlmbel' of 

fnll-tillw equiyalent positions in the Departmellt of Hcalth and Human 8('1'\'ices 

to be' nnmlO'I'1 ill :-mell OW'1' SHell 

('osts, cx('luding costs paid from fe,'s eo1-

leett'd 1l11dc'1' this sedion, for fise-al y('ur 

:WO:1 nmltipli,'d by tll(' i\cljustm('nt fae-tor. 

"(13) CO;\Il'LL\:\CE.-Tlw 8e('rl'tal'~- shall 

he c'ollsidered to llHY(' met the rC'quil'C'ments of 

subparagraph (A)(ii) in allY fiscal ,n:ar if the 

('os1's f'uml(·d h~- appropriations and allo('ntc'd fo], 

the Ill'oeess for the l'C'yiC'w of animal dmg npplieations-

"(i) an' Hot more' than :3 pc ['el'nt 

below tlw kn·J sp('rif'ied in suhparagraph 

or 

"(ii)(I) are more theUl :3 pC']'('ent below 

tIl(' lewl sJleeified ill snbparagl'uph (A)(ii), 

amI fee'S assessed for the fiseal Y(,Hl' fol100\-il1g' the sllbseqm'llt fhwnl ~-ear are de-

('rea sed by the mnollut ill exees:;; of :3 pel'-

rcut by \Yhieh sueh eosts f(·ll bdO'\\' thC' 

lew1 speeifi('(l in subparag'raph (A)(ii); and 

(54364217) 
27 


80810.065

F:\M13\SHIMKUlSHIMKU_002Xl'vlL 

"(II) s11eh ('osts are not mOl'C' than ;) 

2 perel'llt helm\' the len'l speeifil·d ill sub3 parai-rraph C\)(ii), 

4 PHO\'IS!O:-\ j·'OR EARLY l'AYjlE:\TS,-

5 Pn,nnl'nt of fl'C'S Huthoriz('d undcr this sC'etioll 

6 for a fiseal ;'C'Hl', prior to the due datl' for snell 

8 eonlalleC' ,\'iih nnth()rit~, ]H'oyided in aclnmee ill 

9 a prior ~'C'ar appropriations Ad, 

10 A('TIIOIUZATIO:-\ OF API'HOl'RIATIO:\S.-

11 For {'Hell of the fisenl years 2014 through 2018, 

12 th('1'e is aut!JoY'ized to he apPl'opriait'd for fees under 

13 this S{'('tlOll all amount equal to the total 1'C'Wll1t(' 

14 amount determinC'd uwkr sllbseetioll (b) for the fis15 eal y('m" as a(\juste(l or otherwise affeeted uudc[' 

16 subseetiou (e) Hnd pal'ag1'Hph 

17 "( 4) OFFSET OF O\'EHCOLLECTIO:-\S; HECOYEHY 

18 (W COLLE("!,IO:'\ ~TlOnTI·'ALL~.-

20 the Rum of the ('11J1mlatin: amount of fees eol21 leetl'd nuder this Reetion for fisenl ~'ears 2014 

22 through 20H; alld thc amount of fees estimated 

23 to lw eolll'eh'tl under this seetioll for fiseal ~'l:al' 

24 2017 (ine1uc1ing' anr inereased fee eollediolls at25 tl'ilmtahlt· to subparagraph (B)), exeeeds the 

f:IVHLCI0402131040213.116.xml 

April 2, 2013 (5:14 p,m.) 

(54364217) 
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80810.066

F;IM13ISHIMKUISHIMKU_002.XML 

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f:IVHLC\040213\04021 3. 1 16.xml 

April 2, 2013 (5:14 p.m.) 

27 

eumulahw am0111l1 a])])1'0]11'inte(1 pursuant to 

pnrngnlph un for thl' fisc-al ~-ears 201 cf through 

2017, the exc-css amount shall lw C'1'edite<1 to 

the HJllll'opriatiol1 (1e('ouut of till' Food alHl 

Drug Administratiou as pl'oyidl'd in paragraph 

(1), and shall be sl1btnwted from the alllouut of 

fees that \wmld otherwise he authorized to he 

eolleded under this scdioll pursuallt to appl'opl'i<ltion Ads for fisenl :;-e<11' 2018. 

''(B) HECOnmy Of<' C'OLLl~(,Tro:\ 8IIOHT-

'(0) FISCAL Yr;AH :201(j,-For fiseal 

~-ear 201 G, tlll' amollnt of fees othenyise 

authorized to he eollected Hnder this sectioll shall he itlC'l'C'aspd b~! tIle amount, if 

all~-, hy whi('h tIl(' amount eollceted 111](1e1' 

this s('etioll and appropriated for fiseal 

~-('al' 201~ falls brio\\' the amonnt of fet's 

authorized for fifleal ~-ear 2014 n11<1('1' paraFISCAl, YK\H :.!o17.-Fol' fiseal 

year 2017, the Hlnount of fees othl'\"Iyise 

autllOl'iZl'd to he eolketc'd under this se('-

hOIl shall he illC'l'Cascd b~- till' amount, if 

any, by whi('h the amount ('olle('ted under 

(54364217) 
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80810.067

P:\M 13ISHIMKli\SHIMKD._002.xML 

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thi" "e('tion and appropriated i()]' flseal 

~-l'ar :201;i fall" helow the amouut of fees 

authorized fo]' fi"eal rear 2015 under pnragraph (;)). 

"(iii) FISCAL YEAH :201 ".-For fis('111 

year :2018, the amount of feC'" otherwise 

<1ntho1'iz('d to he ('olleeted uuder this seetiOll (illelmling any relinc-fioll in the autllOrized am011llt nnder subparagraph CAl), 

shall be iuereased h~- the eumnlatiw 

amount, if (m~-, b:v \\'hiell the alllount ('01-

leeted under this seetion and Clppropriatl'd 

for fisenl ~T(1rS :201G and 2017 (ilWllldillg 

('stimated ('oJjl'ctiOllS for fisenl ,,'ear 2(17) 

falls lw!my tl1(' C'unmlatiw amount of feC's 

;mtlwl'izl'd under para~'1'aj)h (;3) for fiseal 

~'ears 201 G alld 2017. 

19 \\'hcI'(' the Seeretary dol'S not rl'eein~ pa,nm'llt of a fcl' HS20 "e"sed nudeT s11bs('c,tion (a) ,Yithin ;30 da~~s after it is due, 

21 sn('ll f('l' shall he treat('d ns a elaim of the Fnitl'd State's 

22 Gowrnmellt suhjed to :·mbdmpter II of duqJter :37 of title 

23 :31, Fnitl'd Statl'!) Code'. 

25 T!():\S, A:\D HEFF:\DS.-To qllalii~' foJ' ('ol1!)id('ration for 

f:WHLCI04021 3104021 3. 1 16.xml 

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80810.068

F:\MJ3ISHIMKlJ\SHIMKU_002XML 

a mliy('1' or reduction undcr' subseetioll (<1), OJ' for a rdimd 

3 lll'l'SOll shall submit to tll(' Secretary II written rt'(jl1l'st for 

4 suell ",uiw1', rp(ltletion, or refnml not later than lKO days 

5 after sneh fee is du('. 

6 "W C'o:--;i-;Tfn'("rro:--;.-rrhis section mn~r not be eOIl7 stmed to n·quin' that the Immiw]' of fnIl-time l'quiYH1('nt 

8 positiolls ill the Department of Health alld Human SerT9 for and n(h"isol'Y {'ommittees Hot 

10 ('llg'agp(! in the pro('p;.;s of the j'(',"iew of animal drug· appli11 ealiom;, bl' I'edueerl to offset the mnnhcr of offieers, em12 and adYlsol',Y cOlllmittee's so engagcd. 

14 TIO:--;i-;.-The S('cl'dm'Y s11a11-

15 "0) to til(' e",'tent pl'aetieahk, tIll' re16 ,"il"\" of ahhre,"intl,d Ill'\\' animal dl'11g.' applications 

17 from the ]1l'oecss for the J'l'yje,\' of animal drug uJlJlli18 entiolls; and 

19 "(:2) adopt othcr HdminiRtl'ntiyc proeedures to 

20 CllRlH'P that l'l'yi('\\' times of abbl'(,yiated new animal 

21 drng applieations do not [nen'ase thml their (~mT(,llt 

22 ll'wl due to aeti\rities under the USl'!' fce prognlln.". 

f:IVHLCI0402131040213.116.xml 

April 2. 2013 (5:14 p.m.) 

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80810.069

F:1M13ISHIMKu\SHlMKU_002XML 

>lO 

SEC. 4. REAUTHORIZATION; REPORTING REQUIREMENTS. 

2 Sl'etiOll 7 'lOA of the Federal F'ood, Drug. aml Cos3 metie Aet (21 1',8.(', ;nnj-Vl) is amended to read as fol4 lows: 

5 "SEC. 740A. REAUTHORIZATION; REPORTING REQUIRE6 MENTS. 

7 H(a) PERFOR~IX"CE HEPoHT,-Begilluing ",ith fiseal 

8 :w'ar 2014. Hot later than 120 da~'s aftlT the (']ld of eadl 

9 fiS('(1] year during ",hie11 fees Hre eolk·eted under thi;:; part 

10 the shall pr'epat'(' and suhmit to the Committee 

11 on Energy amI COlllnWI'el' of tlll' House of' Hl'pn~s(>ntatiye;:; 

12 and the Committee on Health. E(lueatioll, Labor, and 

13 Pellsions of the Senate 11 report eonef'rning' the progress 

14 of theF'ood and Drug' Administratioll ill aehi(,ying' the 

15 goals identified ill the lette]'s deseribed in se('tion 1 (b) of 

16 the Animal Drug Fsef' F'ee AnWlHhlll'llts of 201:3 toward 

17 ,'xpediting the animal drug <1eyelopllwnt Ill'o('e88 and the 

18 l'eyi('w of the Ilew and sll]1pl('lllental animal drug appliea19 ti01l8 and im'estig'ational animal drug' suhmissions dmillg 

20 snell fiscal ~'ear) tIl(' fnture plans of the Food l111d Drug 

21 Admiuistration for meeting the goals, the n:yiC"\y times for 

22 nhhrl'Ylnted U('W imimal dmg' klppiieatiolls, and the admin23 ist]'(1til'l' proeedure;:; adopted by the Foo(! and Drug Ad24 mlnistl'utiOlI tn l'llSm'e that rl'l'iew times for abhn'yiated 

25 ]It'w mlill1H I (l!'ug HppJleatiolls are not illereas('(l frolll their 

26 eHrl'('ut lew] due to ndi\'itk's uIHll']' the uS('r' fee program, 

f:WHLCI04021310402U 116.xml 

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80810.070

F:\,"'113\SHIMKU\SHIMKU _()02XML 

:31 

FISl'AL HEPoHT,-Begillning' with fiseal year 

2 :201-1-, not latl'l' than 120 dars aft('l' tlw ('1H1 of ('Hell fisenl 

3 ,war during' \\'hie11 f('es an' ('olleeted under this part, the 

4 Seerdary shall pn'pare nIH] submit to the Committee on 

5 Energy awl Conmwl'ee of the Honse of Repn'sentatiw's 

6 and the Committee on Health, E(lneatioll, Labor, aml 

7 Pensio])s of the Senate a report on the im]1\euwutatioll 

8 of the authority for snell fees during- suc,h fiseal ~'ear and 

9 ill(' 11SP, 11,\' the Food and Drug Administration, of tIll' fpes 

10 eolleetpd during snell fisea] ,\-e<11' for ,yhieh the report is 

12 

13 make the reports reqnil'ed undc'!' subsl'etiolls (a) and (h) 

14 an,ilabk to the publie Oil the Internet W('b site of the 

15 Food alld Drug Administration. 

17 "(1) CO:\8{1L'l'ATIO:\,-Ill dewloping' ],('('-

18 ommelHlntiom: to ]ll'esent to the Congn'8s with re19 sped to the Hnd plans fot' llleeting' the goals, 

20 for the lllW'('SS for the 1'eY1(,,\' of anima] drug appli21 cations for tlw firsi G fi8(,111 :;'ears after fisc'al ~-ear 

22 :2018. and for the rZ',lutilorizatioll of this part for 

23 sl1eh fiseal ~'('al's, the S('('I'etar~T shall eOllsult ,\'it11-

24 the Committee on Eneq;:,- ant1 COlll25 me1'(,(, of the House of R('l)l'C'selltatiyC's; 

f:IVHLC\040213\040213.116.xml 

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33 


80810.071

F:\M13\SHIMKU\SHIMKU . .o02.XML 

"(B) the (\)llllllittc(' Oll Health, Education, 

2 Labor. and Pensions of the Seuate; 

3 Seil'lltifie and llC'ademie 

4 "(D) \'ete1'I11<11'." pl'ofessiOlwls; 

5 "(E) repres('ntatiy('s of patient and ('0]1-

6 sumer ndYOe1w,\' groups; and 

7 "(F) ill(' l'('g1l1nted iudust!'.'" 

8 "(2) PmOH I'FBLlC lXI'l"T.-PrioI' to begillulllg 

9 negotiations \\-1th the regulated ind11st1',\' 011 the rcau10 thorizatioll of this part. the 8ee]'eta1',\' shall11 puhlish a notice in the Federal Reg12 iste]' requesting pnbli(' illpnt on the realltboriza13 tiOll; 

14 "(B) hold U ]lublic meeting' at whieh the 

15 puhlie ma,\' pn'sl'nt its '-1e\ys on the j'NmthorizH16 tion, ineludillg speeifie suggestiolls for elumges 

17 to tIll' goals refelTC'd to ill subseetion 

19 public l1lt'eting to obtain \\Tittl'll comments fro111 

20 tli<' puhliC' suggesting changes to this part; awl 

21 "(D) publish the eomments on tIl\' Food 

22 and Dmg .\dmillistl'ation's Iuternet \Yell sift>. 

23 PEHIODlC COXt'iFUl'ATIO:\.-Xot less fn--

24 qll('ntl~' than ODce {'ym:-' .J: months during' negotia25 tio11s with the regulated iudustry, the SpeH>tilI',\' shall 

f:IVHlC\040213\040213.116.xml 

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34 


80810.072

F:\M13\SHIMKu\SHIMKU_002.XML 

.) .) 

~)d 

2 patient, HlH1 eommmel' adn)('(\(',', gTonps to ('olltillHC 

3 disf'ussiollS of thcir ,ieIYs on the 1'euuthol'izHtioll and 

4 their ,·mggestions for ehanges to this part as ex5 pressed under pal'ngTClph (2). 

6 

7 TIOxN.-Af1:el' llPgotiations ,yith the l'eg111ated indus8 .. tlw S(>('1'eta1';I' shall9 prC'sent the reeol1llllendatiolls deyel10 oJX'd UJl(ll'l' paragraph (1) to the eongn'ssional 

11 ('ommittees s])('eifil'd ill suell paragraph; 

12 d(B) puhlish sHell reeOl1Ul1endatiolls III the 

14 prO\ide for a period of :30 da~-s for 

15 the puhlic to In-mide' written eomnwllts Oil sneh 

16 l'C'(,OHlllll'lHlntioW':; 

17 "(D) hold a meeting' at w11i('h the pnblie 

19 lions; aml 

20 "(E) aftC'1' eonsidel'atioll of snell publie 

21 'dews ana ('Ollllllents, n'yise SUdl rceommemla22 tiolls as neC'C'ssar,\-. 

23 TI:L\X8:ilITTAI, (W m:cmDlEX])Xl'IOX8.-

24 ;\ot later than ,Janni1r~- 15, 2018, thC' Seeretary 

25 shall transmit to COllgTess the re,isC'd reeOlllllll'ndnfWHLCI040213104021 3. i i 6.xml 

April 2, 2013 (5:14 p.m.) 

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35 


80810.073

F:\M13ISHIMKUISHIMKU_OOZ.xML 

tiOlls under paragraph (-+). a snnm1aJ'Y of the "il''''S 

3 all." elwllges made to the reeo1lll1wndations ill I\'-

4 Sj)Ollse to snell yie\\'s aIHl (,Olllllll'nts, 

5 d(G) :\IL\TTES OF :\EGOTL\T!O:\ ~IEETI:\OS.-

6 "(A) PDlLlC "WAIllABlLI'ry,-Before pre7 s(,llting the n'('()]11111('ll(latiolls dew'loped um\('l' 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

paragraphs (1) through to COllgTess, the 

S,'i'PI.tl1,,·,' shall make Jluhliel,l' anlilable, on the 

Internet 'Yeh site of the Food l1llt1 Drug .\dministratioll, minutes of all negotiation lllC'etiwrs eondneted under this subseetioll lwt\\'('en 

the Food and Drug Administration and the regulated industlT 

under subparagraph (A) shall sUl1111lariz(' allY 

substalltiw proposal ]11,1(1e h,\' auy party to the 

negotiations as well ,1S siguifie(111t eontroYCl'sies 

or (liff('l'l'lH'es of opiuion d1ll'ing the llt'g'otintions 

Hnd tlwir resolution.". 

21 SEC. 5. SAVINGS CLAUSE. 

22 Xohyithstandillg the c1llwmlrnents made this Act. 

23 part -l: of suhehnpter C of elmpil'l' \11 of the Federal Food, 

24 Drug" and Cosmetic Ad (21 r.s.c. ;379j-11 et as 

25 ill effed 011 the <la~' hefore the date of the elllwtment of 

f:IVHLCI0402131040213< 116<xml 

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36 


80810.074

F:\M 13\SHlMKU\SHIMKU_002.XML 

1 this Aet, shall eOlltimw to be in cffeet with to ani2 mal drug applicatiolls and suppJenwlltal animal drug' ap3 plieHtiolls (as dd'iued in such part as of sHell day) that 

4 OJl or after Oetober 1, 2008, but before Oc-toher 1, 20U, 

5 were a('('('pted h~- the Food and Drug ",idministrlltion for 

6 filing ,\"it h to assessillg and ('olleeting any fc>e 1'('-

7 quired b~' sneh part fOt, a fisc-al ~-eal' prior to fisenl ~-('m' 

8 201-±' 

9 SEC. 6. EFFECTIVE DATE. 

10 The ampndments made by this Aet sball take effeet 

11 on Oetohel' I, 201:3, or the date of' emwtnwllt of' this .\et, 

12 ,yhieilewl' is later, exec'pt that fees untIl'l' part 4 of sub13 e11apt('1' C of ehapter YII of the Federal Food, Drug, and 

14 Cosmetic .Ad. as HllH'lHlt'd b~- this Aet. shall he ass('sscd 

15 for all animal (h'ug applieations and snppleUlelltal ,mirnal 

16 drug applieatiollS l'ceeiw'd on or after Oetoher 1. 201:1, 

17 regan1]e'ss of the date of the cllaetml'llt of this Ad. 

18 SEC. 7. SUNSET DATES. 

19 (a) ~il"l'I!ORIhATlO:':.-S('e1ion 740 of the Fcdernl 

20 Food, Drug, and Cosmetic Aet (21 r.S.C. :179j-12) shall 

21 eea"e to he l'ff('etiw Oeioher 1, 2018. 

22 (h) REPOHTL\'(; HEQCIHE..\1E:':Tf;.-Seetioll 740A of 

23 tIl\' Fc'dcral Foo(], Drug, and Cos!11l'tie ~\.et (21 FS.C. 

24 :379j-1;3) shall ecase to be ('ffedive ,]l1l1Ual:' :31,2019. 

fWHLC\0402131040213.116.xml (54364217) 

April 2. 2013 (5:14 p.m.) 
37 


80810.075

r:\M13\SHIMKU\SHIMKU_002.XML 

1 (1) I:,,; m~:";El:L\L.-Se('tioll 1 OS of tht' Animal 

2 Drug User Fel' Altlm<imellts of 2008 (Public- Lm\' 

3 110-:1 Hi) is l'ept'aled. 

4 CO:";FomlI:";u X\lE:";J);\IE:";T.-Tlll' Animal 

5 Drug' U;;('l' Fee Amenciuwllt;; of' 2008 (PubJie Lmy 

6 11o-;n G) is nmemled in the tahle of' eOlltents in see7 tion 1, by ;;trikiug' the item relating' to seetioll 108. 

9 lwr IS, 20m;. ;;c'etion i) of' the Animal Dmg' User Fee Ad 

10 of 2003 (Pnhlie Law 108-];)0) is 1'eIW<l1t'<1. 

fWHLC\040213\040213.116.xml 

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80810.076

F:\M13\GARDNE\GARDNE_010.XML 

11:1TIl COXnRE88 

1ST 8ESSJO:\ H.R. 

To 1l111P1H\ tl)(' [,\'(lpl'al Pood, Dmg', aJH1 CoslllPtie Act to 1'l'llUtllOrizt.' user 

f't'(' prograuu; relatillg' to g'()Hf'l'ie Ht'\Y animal drugs, 

I.:"J THE HOrSE OF HEPH.ES}j.:"JT .. :\.TI\'E8 

",\Ir. G,\!{D:\EH illtroduh'(1 tllt' following: hill, \\'hieh \nlS )'eferl'ed to tlw 

COllll1litll'e on 

A BILL 

To ameud the Federal Food, Drug', and Cosmetie Aet to 

reauthorize nser fcc programs relating to g'enerie new 

animal drugs. 

111' it cHartrd b!J the 8(')I(1tc (/1/(1 Hous(' 

2 til'CS ell dcd Slates qtAlllcl'icuin Congress USIW/J·W1Ul 

3 SECTION 1. SHORT TITLE; FINDING. 

4 (a) SHOET TITLB.-Tltis Aet ma~' he eited as the 

5 ") .. llimai Henerle Drug T'ser Fee Amendments of 2013". 

6 (b) Fl':\DI.:\G.-Tlle fees authorized by this AC't will 

7 be dedic-ated tmnll'd e::qlediting the generiC' new animal 

8 dmg deye!opment ]ll'Ot'eSs and the reYle,y of abbreyiated 

f:IVHLC\0402131040213.115.xml 

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39 


80810.077

F:\M13\GARDNE\GARDNE .. O!O.xML 

for nt'w Hllilllal drngs, snppit'll1Plltul 

2 abbl'(,"liajpd applieatiom; for ~rellerie n(,I,' aninll1l 

3 and illYestigatioll<l1 submissions for new animal 

4 drugs as set forth ill the identified ill the letters from 

5 the Seel'etary of Health and Human SeJ'yiees to the Chair6 Illall of t1w Committee on Ellel'gy and Commeree of the 

7 Honse of Hepl'C'spntatiyC's and tlw Chairman of the COlll8 mitt('e 011 Health, Edneatioll, Lahor, and Penf;iol1f; of the 

9 Senate Hf; set forth in the Congressiollal Heeord. 

10 SEC. 2, AUTHORITY TO ASSESS AND USE GENERIC NEW 

11 ANIMAL DRUG FEES. 

12 Se('tion 741 of tlw Federal Food, Drug, alld Cosnwtie 

13 ",\.et (21 TT.::-;.C. :37Hj-21) is amelHled to I't'ad as fol!mw;: 

14 "SEC. 741. AUTHORITY TO ASSESS AND USE GENERIC NEW 

15 Al'ITMAL DRUG FEES. 

16 "(a) TYPES OP FEE!-'.-Dqrinning· ,\'ith respeet to fis17 eal ,war 2009, til(' shall assess and ('olleet fees 

18 ill (leconlmwe with this seetioll m; follows: 

19 

20 

21 

22 

23 

24 

f:IVHLCI0402131040213.115.xml 

April 2, 2013 (5:10 p.m.) 

"(1) AmmEYL\TED <WPLICATIO:\, FEE,-

Ix GEXElL\L,-Eaeh person that submits, on or after ,Tul~' 1. 2008, an Hbbn'yiated 

applieation for a genl'rie new animal drug shall 

lw suhjeet to a fee as established in subst'etioll 

for s11('h an applieatioll. 

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80810.078

F:\M J3\GARDNE\GARDNE_O 1 (l.XML 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

f:WHlCI0402131040213,115,xml 

Ap'il2, 2013 (5:10 p,m,) 

" ,) 

"'(B) PXY:\lE:\']',-'l'he fee required hy snbshall be due UPOll suhmission of 

the ubbreyiated applieatioll. 

EX('EPTIO:\S.-

T1O:\.-Jf an ahbre,iated applieatiol1 wa~ 

~nhlllitted b~' a person that paid the fee for 

such applieation, 'was aeeepted for filing, 

nm! was not or was '\\ithdrawn 

h,ithont a ,I'niH'I' or refund), the suhmisSiOll of all abhn·,iated applieatioll for the 

SHme product by the same I)(:']'son t1w 

P(,1'SOll';; lieensee, 01' 

shall not b(' sl1Qjeet to it fee Hnder sub-

'1'10:\" I:\YOLYl:\G C():llBI:\.\TIO:\ ,\:\l:\L\L 

DIH'G".-.c\,]1 abbrF\iated applieatioll for an 

animal cifsel'ibed in ;;eetioll 512(d)(-l) 

(eom1Jl(ml~' l't'ferred to as a '('ombination 

animal drug') and snbmitted 011 or after 

Oetoher 1. 201 :3. shall be subjeC't to a fee 

equal to 50 pel'l't'ut of the amonnt of the 

abbl'e'liated npplieation fee establi!;\wd in 

snbseetion ('). 

(54364417) 
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80810.079

F:\M 13IGARDNE\GARDNE_O 10.xML 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

!<'l'SED FOH FILI:>\G.-The Secretin:>' shall refund 75 of the fee paid under :mbparng'J'nph (B) for nll,\- abbreylatt·d npplicHtiollwhich 

WITIll)R\W:>\.-If' all ahhn>,inted applieatioll is 

,yithdl'mm after the application was filed, the 

S('creinl',\' lllH,\' I'pfund the fee or portion of thp 

nIldeI' slIbparng'raph (B) if no substantial work was on the application 

aftpr the applieatioll WHS filed. The Speretm:>' 

shall han' the sole disc-retioll to refund tIll' fee 

under this snbpnrHg'l'aph. A determinatioll by 

tht' t'Olleerllillg a refulld under this 

16 subparagraph shall llot be re'liewable. 

17 GE:>\EIUC :>\E\Y .\:>\DL\L J)Hn; PHODlTT 

18 PEE.-

19 "(A) Is UE:>\gHAI,.-Each pel'SOll20 ('(1) who is llarned as the applieant JJJ 

21 all abbn'\'iated applieation or snpplemental 

22 abbn·,iated applieation fill' a gellerie new 

23 animal drug pl'odnet 'whieh has beell sub24 mitted for listing under se{'tio]\ [)10; and 

f:\vHlC\040213\040213,115,xm! 

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80810.080

F:,"'v113\GARDNE\GARDNE_O 1 OXML 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

fWHLC\0402131040213,115,xml 

April 2, 2013 (5:10 p,m,) 

;) 

,yho, after ::-\eptemhel' 1, :2008, 

had pending bef()!'(" tht' Secretary un nhhl'eyiated applientioll or supplement.al ablwt'-

yiated application, 

shall pa~' for eaell suell genel'le' lit'\\' Htlilllal 

drug produet the allnual fee established in subseetioll 

FE:f,J IWE IUTE.-Sueh fee 

shall be pa~'ahle for the fisenl year in wiJieh the 

!lew animal drug produet is first submitted for listing under seetion ;) 1 0, or is snhmitted for I'elistillg' ullder seetioll 010 if the generie Iwyr animal drug' prodnet has lwen withdrawn from iistillg and relisted. Aftel' SHell fl'e 

IS for that fiseal year, suell f('(' shall he chw 

enell subsequent fiseD! ~'('ar that the product 1'('-

malllS listed, upon tllt' latl'I' of-

"(i) the fil'st busilless dn~' after till' 

date of t'll1wtllH'nt of an appropriations Act 

prmicling fot' til(' eolleeticlll and obligation 

of feE'S for such fise1'11 ,\'ear nnder this Sf'etion; or 

"(C) LDII'l'NflO'\.-Such fep shall bt' paid 

onl~' Olwe for path generie new allimal drug 

(54364417) 
43 


80810.081

F:\M 13\GARDNE\GARDNE_O lO,XML 

(j 

1 prodlwt for a fisenl ~'t'm' ill w11iel1 the fee is pay2 aIM. 

4 FEK5 1:; GK\EI~.\L.-Eaeh pel'SOIl6 "(i) who meets the definition of a ge7 ner1e HeY\' animal drug sponsor ",itIliH a 

8 fisea1 ~'eHr; and 

9 "(ii) \\'110, after September 1. 2008, 

10 had pending: before the Seeretal'Y an ahhrp11 yiated app1ieation. a snpph'lll('lltal abb1'e12 "lated application, 01' an inwstigational 

13 submission. 

14 shall be assessed all ammal gellerie lWW animal 

15 drug spOJlsor fl'e as established Imder sub16 set't iOll (e). 

18 shall bt· dup enell fiscal ."ear upon the later of19 "(i) HIP first business day after the 

20 date of ellaetnwnt of an appropriations Aet 

21 pl'o\idillg for the c'olleetioll a])(l ohligation 

22 of fel's for snell 1'i8e111 ,H'(ll' lmde\' this st'e23 tiOll; or 

24 ,Januar.'I':31 of eaeh ."t'a1'. 

f:IVHLC\040213\040213,115,xml (54364417) 

April 2, 2013 (5:10 p,m,) 
44 


80810.082

F:IM13IGARDNEIGARDNE_010,XML 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 aIHl 

7 

animal drug sponsor shall pH~' onI,'>' 1 snch fee 

caeh fiseal .war, as f'O]Jo\Y8: 

"0) 100 pE'l'C'ent of the Hmount of the 

g'ellerie IWW ctJIimal drug spousor fee pnblished for that fiseal ,\'par under snbs('dion 

for an a])pliea11t with more t hall G appl'oYed ahbre'liatpd applieations, 

"(ii) 7;' jlerC'pnt of th(' mnOll1lt of thp 

up,,, Hnimal dmg sponsor' fpp published for that fisC'al year Hlld(']' subs('C'tio11 

(e) for an applil'ant with more than 1 awl 

fe,,'Pl' than 7 apPI'()H'd abbr(,Ylatpd applieatious, 

;'0 of the amouut of tlw 

g'Pllt'I'jC lW,Y animal drug sponsor £'pe puhlished for that £'is('al ,\'ea1' nllder snhseetion 

(c) for an applicant with 1 or fe'wer npprowd abbn"iated applieatiolls, 

shall 

22 he establishc'd to generate fep IV\'c'I1lW amounts as follows: 

24 FEES,_rrhp total fee l'pwnues to be eolleeted in ah25 hl't'yiated application fpes under subsection (1\)(1) 

f:IVHlCI0402131040213,115,xml (54364417) 

April 2, 2013 {5:10 p,m,) 
45 


80810.083

F:\M 13\GARDNE\GARDNE_O 1 O.XML 

shall he ,;)82,000 for fiseaJ year 2011, :fl1.7:'lG,OOO 

2 for fiseal ~'ear 2013, $1,837,000 for fiseaJ ~'('ar 

3 201G, $tH8J,OOO for fiseal yenr 2017, awl 

4 $2,1l7J100 for fiseal ~'ear 2018, 

5 TOT.\L FEE H.En:xn:S FOH PHODlTT 

6 FEES.-TIlt' total fee l'eW'IlUes to be eolleeted in g'e7 l1erie lWW animal (lrng: pl'oduet fees under snbseetiOll 

8 (a)(2) shall IX' 7-l8,OOO for fiseal rear 20H, 

9 $2,GOJ,OOO for fisenl ~TlH' 2013, $2,78G,OOO for fis10 eal year 201G, $2,H7G,OOO for fisenl year 2017, and 

11 7.1,000 for risenl ~'ear 2018. 

12 TO'L\L FEE Imn::xrES FOB SPOXSOH 

13 FEES,-The total fel' reyennes to be eolleeted ill ge14 ll(,l'ie UP-I\, animal dl1lg' spOllsor fpps UlHkr snbsee"tioll 

15 

16 

shall 1)(' 718,000 for fiscal ypar 201.1:, 

$2,()01,OOO fo]' flseal year 2015, 786,000 for fis17 eal year 201G, $2,976,000 for fiseal ~'ear 2017, and 

18 $:),175,000 for fiseal year 2018. 

19 A:\'XI'AL FEE ;-)ETT1XU; AD.]l'tiT:\IEXTti.-

20 "(1) AXXL\L FEE SETTIX(i,-Thp Seeretary 

21 shall ('stablish, flO dars before the start of eaelJ fi8-

22 cal .';ear beginnillg aftt,l' Septemlwr 80, 2008, for 

23 that fisea! ~'ear, abbl'eyiated appiieatioll fees, generic24 ne,Y animal drug spOllsor Hnd ~teneri(' Hew [ln1-

25 mal dl'llg prodnet fees, based Oll the rewnue 

f:WHlC\040213\040213.115.xml 

April 2, 2013 (5:10 p.m.) 

(54364417) 
46 


80810.084

F:\;'v113\GARDNE\GARDNE_ 0 IOXML 

9 

llU10lLlltS pstablished lllHlt::'l' suhst::'etloll (11) aIHI tlw 

2 3(ijustments 11l'Oyit!cd nndel' this sllbs(,ctioll, 

4 nues shall be adjnsted eaeh risenl ypar after fiseal 

5 ~'('nl' :201 ± to ref1ed III 1'e\,jew \yorkload. 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

f:WHLC\040213\040213.115.xml 

April 2, 2013 (5:10 p.m.) 

\,-jtll to SHell (\(lj11stment: 

This (l(\iustmellt shall hp determined 

b~' tlw Speretnl'Y based on a \wighted awrage 

of the e]mllge in the total ll1mlbpl' of abhl'e-

,iatecl applieHtiolls for generie lW\Y animal 

drugs, llmmlfaeturillg snpplel1ll'ntal abbJ'{'yiatpd 

applications for g-t'llPrie new animal dmg'S. inY('stig:ational g'Pl1el'ie m',y animal drug stud:-' 

alld illYesiigational 

animal drug protoeo\ submissiollS ;;ubmitted to 

the Se('rctm'~', Thl' SeeI'etar',\' shall publish III 

the F'e(lprnl I\pgister the fees t'esulting frolll 

this adjustment and the supporting methodoloFlldt'l' llO eiremnstnnees ;;!Jall this 

\\'orldoad H(\justment result in fel: l'FH'llUes for 

a fisenl :,'ca1' that art' less than tht' fee I'l'wnues 

for that fiseHI ~'('ar t'shtblislwd in subsel'tioll 

(b ). 

(54364417) 
47 


80810.085

F:\M 13\GARDNE\GARDNE_OlO.XML 

10 

2 ma~', in addition to othE'r 

3 IllldE'r this subsE'etion, further inerease 

4 the fE'es maIer this fle('tioll, if snell an c1(\justmC'ut is 

5 llP('('flSHI',", to proyide for up to :3 lllonths of opel'-

6 Ming reSet,,\T'fl of ealTYOYPl' Ufl(,], ft'E's for tIw proel'SS 

7 for tllp reyjeYI' of abbt'l'\'intl'd appJieations for 

8 11(,\'1' animal dmgs for the first ;:l mOllths of fisenl 

9 ~'eal' 201H. If the Pood Hnli Dl'l1g: Administration 

10 has eHI'I',"OYCr halalll~es for tllp pl'Oeess for thE' I'E'yiew 

11 of ahln'cyiated applientiolls for gl'IlE'l'ie HE'W animal 

12 d:rngs ill e'xee'ss of :l months of s11ell operating l'P13 St'lTPS, then this H(\jUStlllE'ut shall not be' madE', If 

14 this mUw;tmeut is neC'E'SSaI',", thE'H the' rationale for 

15 the Hmount of tIlt' ill(,l'ease shall he (,Olltaiupd in the 

16 anllual llotil'f' seiling fE'es for f'isenl ,war 2018. 

17 LBHT.-The total amount of fees 

18 as adjusted under this subsection, fot' a fisenl year 

19 may not exceed thE' total costs for such fiseal ,H'ar 

20 for thE' I'Psonre('s alloeatt·d for Hw proepss for thE' re21 "iFI\' of abbl'eyiatE'd appjieatiolls for gl'llPt'ie lWW ani22 maJ drngs. 

23 "(d) FEE \\',\I\lm Or{ HElHTTlO.\".-The 

24 shall In 'ant a \Yaiw'1' from 01' " l'eduetioll of 1 or morE' fees 

25 asspssed under snbsection 

f:IVHLCI0402131040213.115.xml 

April 2, 2013 (5:10 p.m.) 

(54364417) 

where the 8('('1'("tm), finds 
48 


80810.086

F:u\l[13\GARDNE\GARDNE_OIO.xML 

that the gellel'i(' IW\Y animal drug is illtemled solel,\' to pro2 yidp for a minor nse or minor indientiol1. 

3 

4 yiatect appii('atioll for a gellerie 11eIY animal drug suh5 mitted b,\' a per>';on snbjed to fee>'; under >,;uhsedion 

6 >,;hall hE' ('onsidt'l'pd ineomplE't{, and shall Hot bp 

7 for the Rp(,l't'tary until all feE'S O\yed by sHell per8 SOil lmre lW(,H paid .. An inwstigational suhmission for a 

9 l1e\\' animal dntg that is submitted b,\' a pt'I'SOll 

10 suhje('t to fl'l's uuder subseetioll (a) shall lw eonsidel'ed 

11 illtOmpjetp Hnd shall not he aeeeptpd for l'eyjew 13,\' the See12 until all fees owed by suell person haw been paid. 

13 The Seel'etary may diseontinne reYlelY of any abbreyiated 

14 applieatioll for a gC'llt'rie 1)("\\- animal drug, supplemental 

15 abbl'('yiated applieatioll for 1:1 gellerie lll'''' animal drug'. or 

16 jnn'stigational submission for a generie m'w animnl (lrug 

17 from a person if ~m('h pel'son has not submitted for llay18 lllmt all fpes owed nnder this spetion br ;30 days after 

19 the date upon yrhieh tlwy are dne. 

20 "(f) ASSEssm::\"'!' OF F'EES.-

21 "(1) 11DlfTATI()~.-F'('es nla~' not be assessed 

22 under subsedioll (a) for n nS(,HI yt'nr lwginnillg nft('!' 

23 fisea] year :WOR ulll(,ss appropriations for salaries 

24 and e;qwnses of the Pood and Drng ,Administration 

25 for sneh fiseal yea]' (exeluding the amouut of fe'c's 

f:IVHLCI0402131040213.115.xml 

April 2, 2013 (5:10 p.m.) 

(54364417) 
49 


80810.087

F:\M 13\GARDNE\GARDNE_O 1 O.XML 

12 

appropriated for sneh fiseal year) are equal to or 

2 ,2.watpl' than the amoullt of appropriations for the' 

3 salCl1'iPR and e'XIJE'IlRe;; of tlll' Food and Drug Admill4 istratioll for the fi;;eal year 200:3 (t'xdnding the 

5 amount of fees appropriated for slll'h fiRe-al 

6 nmltiplic'd by the (t(\jnstmt'llt faeto1' applieHble to the 

7 fiseal ~-eal' illyolwd. 

8 ACTI!OHITY.-If the 8eel'etm'~- dOl'S not 

9 asseSR fee;; l1neiPl' Rubseetion (a) during aH~- portion 

10 of n fiseal year heemlse of paragraph and if at 

11 a later date ill sneh fiseal ~-E'ar the 8eel'etmy may as12 SC'RS sueb the 8eel't'tary llla~- aRRess and eollE'et 

13 sneh ft't'R. without an.'- modifieatioll in the ratt', for 

14 abhl'eyiatpd applieation;;, gl'neril' lWW animal drug 

15 SP011ROI'S, and gellerie IWIY animal drug produets at 

16 ml~- time ill SUdl fiseal year llotwithstanding the pro17 yisiOllS of Rubseetion (n) to ilw date fpl'R are 

18 to 1w paid. 

19 "(g) CHEllITI:-:(l A:-:Tl A':.\IL"\B1LlTY ()li' FEES.-

20 "(1) 1:-: m:.'\ER\L.-8nbjpC't to paragl'aph 

21 feE'R anthorizE'd nuder Rubsl'etion shall bp 

22 eolleett'd and ayailable for obligation 0111;\- to tllE' ex23 tt'llt and in the amouut IH'ly\idl'd in 11(I\-a11ee ill ap24 pl'opriatiolls Aets. :Snell fpc'R art' authorized to be ap25 propriatp(l to remain ayailable until expPIHled. 8'W11 

f:WHLCI0402131040213.115.xml 

April 2. 2013 (5:10 p.m.) 

(54364417) 
50 


80810.088

F:\M13\GARDNE\GARDNE_OIO.XML 

1d " 

sums as lllay be IlPC'PSSI1l'Y ml1y be transferred from 

2 the Food and Drug Administration salaries and ex3 penses appropriation a('('onnt ,\ithont fisenl year lim4itntioll to sueh appropriation neeount for salary and 

5 e)..l)ens('s ,lith snell fiseal ~-eal' limitation. Tlw sums 

6 transferred shall be lwailable solely for tIl(' proee:;;s 

7 for the l'e,ie,\' of abbn'yinh'd applieatiolls fo1' gPlwrie 

8 Hew animal drngs. 

9 COLLECTIO:\S API)H(lPmATIO:\ 

11 Ix GE::\EIL\L.-The fee:;; authorized 

12 this seetion13 "(i) sn11jeet to subparagrapb (C). :;;hall 

14 be eollc'eted nnrl ayailable in ecwh fiseal 

15 year in an amount not to exeepd the 

16 alllount speeifipd in appropriation .Aets. or 

17 otherwise made ayailnble for obligation for 

18 snell fisenl ~'enr; aud 

19 "(ii) shall be ayailahlp to dE'frar in20 (,l'pas('s ill the ('osts of the resonrees allo21 ('atpd for the proee;;;s for the I'c'yiL'\\' of ab22 hre,iated nppiieations for gellerie HelY C1ni23 mal drugs (ineluding inereasE's ill sneh 

24 eosts for all additional l1lunber of fnll-tinw 

25 

f:WHLCI040213\040213.115.xml 

April 2. 2013 (5:10 p.m.) 

e<]ulyalE'llt in tile Department of 

(54364417) 
51 


80810.089

F:\M13\GARDNE\GARDNE_010.XML 

2 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

1.9 

20 

21 

22 

23 

24 

f:\VHLCI0402131040213.115.xml 

April 2, 2013 (5:10 p.m.) 

ill :mell oyer suell <'xeludillg 

('osts paid from ft'e" ('olleC'h'd under tlli" 

for fisC'al year 2008 multiplied b,\' 

the a(\justment faetol'. 

CO:\ll'LL\;-;CE.-Thc' Sec'l't'tary shall 

he eonsiciered to haw met the requirements of 

suhpm'agTaph (A)(ii) in an~' fiseal ,\'"a1' if the 

('osts fum led by appropriatiolls and allocatl'd for 

the Pl'Of'E'8S for the reyipw of abbrl'yiate(l applieatiow; for gellPric Ill'W Hnimal 

are !lot more than :3 pel'ePllt 

below the lewl specified in subparagraph 

(ii); OJ' 

"Oi)(1) are more than :1 pereent lwlo\\' 

the lewl SIH'cifie(l in subparagraph 

and fep8 ass('ssed for the fiseal year folluwiug the ;;ubsequPllt fiscal ;vea1' a1'e dee1'Pl:1se(l by the amount i!1 ('wess of :3 per-

(,Pllt by whieh sneh ('osts fell belm\' thl' 

lewl speeified ill snbparagTHph ,mil 

"(II) 8ueh eosts are not more than ;) 

[lerC'ellt be]O\,' the ]p\,('1 sppeified in snbpal'l:1p'nph (A)(ii). 

(54364417) 
52 


80810.090

F:\.M13IGARDNEIGARDNE_010.XML 

1 

2 

3 

4 

5 

6 

L5 

PHo\'ISfO:\ FOH K\HLY 1'.\Y:'IE:\TS.-

Payment of fee;; authorize(l Ullder this s('etion 

for a fi"enl year, prior to tIll' due' date for ;;ueh 

the Seeretary ill (1(,-

eOl'dmll'e ,rith anthority prmided ill ach'nllep in 

a .\'('a1' appropriation" Aet. 

7 At'TlIOHl%.\TIO:\ OF .\PPIWPHL\TIO:\S.-

8 There are authorized to be appropriated for fees 

9 uuder this sl'etiollto "(A) $7,:t~8.000 for fiseal year 20U; 

1] "(13) $G,944,OOO for fiS(,HI yE'iH' 201;); 

12 ,429,000 for fisc-al ~'ear 20H;; 

13 "(1)) $7,D:3G,OOO for fisNll ,WiU' 2017; and 

14 $8,467,000 for f'iseal ~'ear 2018; 

15 a;; adjusted to ref1eet adjnstUlcuts ill the total fee 

16 I'e'H'lllleS llliUI(' lll]( leI' t Iii" st'etiol1 and ehiUlgt'S in the 

17 total amoullts eolleeil'd b)' ablll'eyiated applieatioll 

18 gellerie 1]('\\' animal (h'ug sponsor fees, and ge19 nel'ie llE'YI' llllimal p1'o(\uet fet's. 

20 OFFSl<;T.-If the snm of the ('ulllulati\'(' 

21 amollnt of fees eolleeted ullder this seetiol1 for the 

22 fiseal .wars 2014 20Hi and the amollnt of 

23 fees e"timate(\ to b(' eolleeted under this seetlo11 for 

24 fiseal rear 2017 l'xeeeds the eumulatiyc alllount ap25 

f:IVHLC\040213\040213.115.xml 

April 2, 2013 (5:10 p.m.) 

for the fist'al ,"pars 

(54364417) 
53 


80810.091

F:\i'vlI3\GARDNE\GARDNE_(ll OXML 

Hi 

:.l014 through :.l017, tIlt' ex('(':,:" amouut shall bt' 

2 ereditl'd to the appropriation m:('onnt of the Food 

4 (1), aml shall he' snbtraeted from the amoullt of fees 

5 that ,nmld otlll'I'wise be nutliol'iZt,d to he eolleC'tE'd 

6 uuder thi~ seetlon pursuant to appropriatioll Aets 

7 for f'iseal year :2018. 

8 "(h) COLLECTTO;\; OF LT;\;P.\IJ) FEES.-Ill allr ense 

9 ,ylwre the Seel'etm~' does not l'peeiw pnymE'nt of a fpe as10 sessed under subs(·etion within :i0 dnys af'tC']' it is due, 

11 sl1('11 fee shall be treated as a elaim of the Unih·(l Statps 

12 GowrnmE'llt suhjeet to subehaptel' II of ehapter 87 of titlE' 

l3 Fuited States Code. 

15 '1'10:'\8, A:,\D HEF1':,\l)s.-To qualify for C'ollsideratioll for 

16 a ,YaiYer or rednetioll under snbseetion ((I). or for a refund 

17 of ml~' fep eo]Jel'1ed in aC'C'ordHllet' with snbseetiol1 (a), a 

18 person shall submit to the a written request for 

19 sneh \wli\'er, reduction, or rE'fund not later thall 180 days 

20 after sueh fee is dne. 

21 CO:'\8THlTTIO:'\ .-This seetiol1 may Hot 1)(' (,Oll22 stnwd to require that the lHunht'l' of full-time eqniy,\lt'ut 

23 positions in the Dppartment of Health and Human ReIY24 for offi('et's, emplo,Yees, and adyisot~, eommittt'es not 

25 cllg'aged ill the process of till' rt'yiFW of abhreyiatE'd applif:\VHLC\040213\040213.115.xml 

April 2, 2013 (5:10 p,m.) 

(54364417) 
54 


80810.092

F:IJI1 J 3\GARDNE\GARDNE_O I OXML 

17 

eatiom: fOI' nE'l\' Hnima! dru}.rs, be I'edneed to offset 

2 the llUlIlbet' of offieeI's, and mhisol',\" eommit3 tees so 

4 DEFIXIT!oXN.-fll this ::;eetion and seetioll 7 :~2: 

7 applieation foe a gellt'l'ie Hew animal drug' an(1 'ab8 bre'liaiC'd appji('atioll' lllean an nbbn'yinted nppliea9 tion for til{' apprm'nl of any gi:'llerj(~ new anima! drug 

lO suhmitted umleI' seetion :i1:2(b)(2). Slw11 term does 

II not inC'lnd" a SUppll'llwlltal ahhl'e,iHted applieatioll 

12 for a genpl'ie lW\Y animal drug. 

13 AD.Jl"NT:\IEXT F.WTOR-The term 'mUust14 ment fadm" appJieable to a fiseal year is till' Con15 smrll'l' 1'1'1('1' IJl(lex for all urban eOllsumers (all 

16 items; Fnit('d States eity (1Yt'l'agl') for Oeiobel' of the 

18 

19 

20 

for purposes of subseetioll (f)(1), 

SHeil IndE'x for OetollPl' 2002; atld 

for PllI'POSt's of subs('c,tioll 

21 :meh IHdE'x for OetoheJ' 2007. 

24 ,\PPLIC.\TIOXN POl{ GEXEmC XEW"\XLlL\L DRl'GN.-

25 The tl'1'm '('osts of I'PSou!'('('s allc)('atE'(l fot' the pl'oeI:WHLCI0402131040213.115.xml 

April 2, 2013 (5:10 p.m.) 

(54364417) 
55 


80810.093

F;\M 13\GARDNE\GARDNE_OlOXML 

1M 

2 llerie Ill"\' animal drugs' means the \'XpellSPS in e011-

3 ll('(·tioll with the' Pl'O(,PSS for the l'PYIP\Y of abhrp4 VIa ted applieations 1'01' g'('nel'ie ue,\" animal dl'l1g's 

5 for6 "(A) offieers alld E'mploYE'es of tilE' Food 

7 and Drug AdministratIo11, eontraeiors of thE' 

8 Food and Drug ;\dmiuistl'atioll, a<1yi801','" e0111-

9 mitteE's eonsuIted \\,jtll respeet to the ]'('Yle\y of 

10 speeifie ahl>r'p\'iated applications. snpplemental 

11 ahhreyiated applieatiolls, or inwstigational sub12 and {'(lsts related to suell offieers, elll13 committees, and eOlliTaeiOl'S, ineluding' 

14 costs for if'aye!, e(hwlltioll, and reel'uitlllent and 

15 other personnel aetiyitiesj 

16 mamlgelllE'llt of ill formation, and the 

17 aequisitioll, mailltelHlllce, aud repair of ('0111-

18 pnte!' resoun't'S; 

19 leasing', maintenaJlce, rello'l'alioll, and 

20 I'epniJ' of fneilities awl (]equisitioll, maintemmet\ 

21 

22 

23 

24 

25 

fWHLCI0402131040213.115.xml 

April 2, 2013 (5:10 p,m.) 

Hnd l't'pair of fixtures, furniture, scientifie 

equipment, and other llH'('SS(u'~' mnterials and 

supplies; and 

"(D) fet·s under this seetiol1 and 

nceonntillg' fo)' resources a lloeated fot' tIl(' re-

(54364417) 
56 


80810.094

F:\M13\GARDNE\GARDNE_010.XML 

2 

3 

4 

5 

6 

19 

,lP'" of ahhl'eyiated applieatiolls, snpplement.al 

ahhn'yiated applieatiolls, and inn'stigatiollal 

submissions. 

"'(4) FI:,\.\li nosvm FOlDI.-TJw tprm 'fillaJ 

fonn' means. with t.0 H new 

animal prO<1uet, n finished dosage form ,\'l1i('11 

7 is npproyed fot' administration to an Hnimal "ithout 

8 substmltial further I1lmmfaetllrillg. 811('11 term in9 cindt,s gt'Jlerie lWW animal dmg products intended 

10 for mixing in Hnimal feeds. 

12 11l',Y llllimHI dr'llg' lllC'HllS a lW\\, animal dI11g 

13 that is the subjeet of all abbl'eyiatpd application. 

14 "(6) GE:'\EHIC :,\EIY ,\:'\L\L\L Imnl PROlH·CT.-

15 The term l1\',Y auimal drug prodn('f means 

16 eneb speeifie strength or potel1l'Y of a particular nc17 tiye ingTedimt or ingTediPllts in fimll dosage' form 

18 m<1rketl'<l by 11 partienlar manufueture'l' or dis19 trihutor, ,yhieh is lluiqm'ly i\lE'lliifipd by the laheh'l' 

20 ('ode mal produrt eo de portions of the llational dl1lg' 

22 g('nerie new allilllHl drug or a snpplemental abbl'e23 yiated applieatioll has been approyed. 

24 GE:'\ERlC ,\'EW A:'\I:\L\L lmn} 8PO:'\SOH.-

25 The terlll 'generiC' IW\,\, animal drug sponsor' meaDS 

f:IVHlC\0402131040213.115.xml 

April 2, 2013 (5:10 p.m.) 

(54364417) 
57 


80810.095

F:\M J3\GARDNE\GARDNE_OlO.XML 

2 tion for 11 gl'llerie ne,\' animal drug that has not h('('n 

3 withdra\nl h:' the npplieallt and for whieh approYHI 

4 bas !lot hePll ,\ithdraWll by the SeeretHl'.\". 01' a per5 SOIl ,,,ho has snbmittpd an illYestigational submission 

6 for a g'Plll'l'ie IW,Y animal dl1lg that has not hePll tp1'-

7 miuatpd or otherwise rendered i11[1('tiYe br the S('('-

8 rptary. 

9 "(R) I:;YESTH}Xrro:;,\j, snnIlSslO:; FOH .\ GE10 XEH1(' XE\y ,\XnL\L DHCG.-The terms 'illwstiga11 tiollal submission for a new animal drug' 

12 and 'iuwstigMional submission' 11)e(1n13 the filiug of a el<1im 1'01' an inYestig'a14 tiolla! t'xemptioll undp!, S(:'etiOll :5120) for a gt'-

15 nel'ie UP\\" Hllimal drug 11ltPllded. to 1)(' the sub16 jed of an ahbn'Ylnic'd applientioll or n supple17 mental abhn',iated applientiou: 01' 

18 the submission of information for the 

19 pmpost' of enabling' the Secretary to eyaluate 

20 

21 

22 

23 

f:WHLCI04Q2131040213.115.xml 

April 2, 2013 (5:10 p.m.) 

the ]]t'w animal drng: in the eWllt of the filing: of an allhre-

,iat('d applicatioll or snpplemental abbn'yiated 

applieati.ol1 for sneh dmg, 

(54364417) 
58 


80810.096

F:\M 13IGARDNEIGARDNE_O 1 O.XML 

21 

PEHSOX.-'I'll{' ter111 'pet'son' illc-Judes an 

2 affiliate thc-reof (as suc'h term is dd'iupd ill s('('fion 

3 7:35(11)). 

4 "(10) PHOCE8S POll THE HE'lE,y (W ABUHE6 DHrG8,-The term for the fPy:!e,\" of a blm--

7 "iMpel applieations for i,rellPrie llew nllimaJ drug-s' 

8 menns the follo\',ing aetiyities of thp S('C'retm)' ,yith 

9 to thp l'Pyie,y of ahbreyiuh'd applieations, 

10 supplemental ahllI'eyiatpd applieations, and illYPs11 tigational submissions: 

12 "(~\.) The aethiti('s necessary for the I'e13 yip\\, of abbre,iated applications, snpplpl11Plltal 

14 

is 

16 

17 

18 

19 

20 

21 

22 

23 

24 

f:IVHlCI0402131040213.115.xml 

April 2. 2013 (5:10 p.m.) 

abbre,-iat('(l Hpplieations, and irn'('stigatioll111 

submissions. 

TIlE' ISSllHUet' of actioll letters ,yhieII 

appl'oYl' abbre\iated applientions or supplellwlltal ahbn',iated 01' whieh Sl't 

fOl't11 in dptail tIlP speeific defieieueies ill abbl'('-

yjnted applieutions, snpplC'm(,lltal abbn',iatp(l 

applieatiolls, or inwstigntiOllal snbmissiolls aud, 

plate snell appli('ntiol1s, snpplemelltal applieatinlls, 01' submissions in eonditioll for appl'oy(ll. 

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2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

22 

"(C) Tilt· inspt·C'tioll of llt'W animal 

drug establishments und other faeilitips undpl'-

takcll as pmt of tIlt' t:\pel'ptary's l'Pyiew of pendahbJ'(:,Ylated applieatiol1s. snpplemental abbl'PYla t(?d appliC'atiolls, and inyestig'ationH 1 submissions. 

"(D) }Iollitoring of research eOll<iueted ill 

e01l11t'etioll with the l't'Ylew of abbl'eyjatp(l applisnpplemental abb!'("\iatpd applieatiom;, 

1\1\(1 illwstigational submissions. 

The deydopl!lent of regulations and 

supplemental abbreviated applieations, 

and illwstigational submissions. 

"(F) DpyPiOPlllPllt of standards for produC'ts 

17 }IE'phllg:s lwhwpl1 the ag'plH'Y and the 

18 gelwrie np\\, allimal drug sponsor. 

19 "(TI) Rpyipw of mb:el'tising amI labeling' 

20 prior to allpnmll of nn abhl'Fliated applieatioll 

21 or suppleulPutal abLn't'yinted applieation, hut 

22 Hot nfter sHeil applieatioll has been n1'1'1'oYt'(1. 

25 'supplt'lllental abhl'e,iatpd applieatioll for a g'l'lH:'I'ie 

f:WHlC\040213\040213.115.xml (54364417) 

April 2, 2013 (5:10 p.m.) 
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F:\M13\GARDNE\GARDNE_OIOXML 

lle,\' animal and 'sllppleIlH'lltal ahbt'eyiated ap2 

3 

lllean a t'eqlwst to the Seeretary to approye a III nn npprowd abbre\rlated applieH4 tinn.··. 

5 SEC. 3. REAUTHORIZATION; REPORTING REQUIREMENTS. 

6 Seetioll 712 of the Fedt'J'al Food, Drug, and ('osJl1etie 

7 Ad (21 r.s.c. is amended to 1'('a(\ as follows: 

8 "SEC. 742, REAUTHORIZATION; REPORTING REQUIRE9 

10 

MENTS. 

11 enl year 2011, not later than 120 days aftel' tbe pnd of 

12 eaeh fiseal ~-enr duringIYbieh fees nt'e eolleeted Hilder this 

13 purt, the Seeretnry shall prepare nnd submit to the Com14 mittee on Health. Edueatioll, Lnbor, and Pellsions of the 

15 Senatt'. and the Committee on Ellt'f'gy and Commeree of 

16 the House of Rq)l'esentatiws a report eOHeeming the 

17 progress of the Food aIHl Dl1lg Administration ill ,whiey18 the idpntified in tll(' letters desel'ibed in seetion 

19 ] (h) of tIw Animal Gt'llt'ri(' Drug ~est'r Fee Allwlldments 

20 of 20B tmnlnl ('xpediting' the ne's aJlilllal drug 

21 pl'oel'ss alH! the I'('yiew of abbre\rlated nppli22 cations for lH'W animal drngs, supplemental Hbbl'e23 ~dated applieatiolls for new animal and ill24 wstigatiOlml submissions for generiC' new animal drngs 

25 during SHell fis('al ~"eal'. 

f:IVHLC\040213\040213.115.xml 

April 2, 2013 (5:10 p.m.) 

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"(b) FI:->C.\L HEPoRT.-Beg'innlng with fis('al year 

2 201·t not Inter than 120 after the ewl of ('11th fiseal 

3 ~T'ar during whieh fees are eolleeted under this part, tlle 

4 Reel'etary shall prepare and submit to tile CommittE''' on 

5 Hpalth. Edul'Htioll. Labor, and P(Onsiol1s of the RE'llate Hnd 

6 tlw CommittE'e Oll EUE'rgy and COlUllleree of the Honse 

7 of Helll't'sE'ui.atiws a n'pol't on the implementation of the 

8 authority for sneh fpps during' sueh fiseal ~\'m' allCl tlw 

9 use. L~' the Food and Drug Administration. of the fees 

10 eoJledt'd during sueh fiseal Y('Ul' for ydliC'h tlu' IS 

11 made. 

12 PrBLIC .c\Y,UL\BlLITY.-The ReC'retm,;\' shall 

13 make th,' reports required under subseetions (a) nud (b) 

14 m'ailable to tIll' Imhlie Oll the l11tel'lwt Web site of the 

15Pood aurl Drug Admilllstrntion. 

16 

17 

18 

19 

HE.\l"TIH nUZATIO:\ 

OntllwlldatiollS to preseut to 

the goals, and pIalls for 

\\'ith respect to 

the goals. for thl' 

20 prOt'C'ss for tIIP Y'P\'i(',y of abhI'pyiated Hllplieations for 

21 new Hnimal drugs foJ' the first i) fiseal years 

22 after fisea! ~'eal' 2018, and for the I'pantllOrizatioll of 

23 this part for suth fiscal ~'eal's, the Recl'etm,;\' shall 

24 consult \\ithf:\VHlCI0402131040213.115.xml 

April 2" 2013 (5:10 p.m.) 

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F:\!VI13\GARDNE\GARDNE_0l Q,XML 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

the COlllmittee' 011 Enl'I'K\' and COUllllt'l'l'(' of tht' Honse of Represputatiw's; 

"(B) the Committe'(" on Henlth, Edneatioll, 

Labor, and Pensions of the Reuate; 

seientifie Hnd aeailemi(' ('xperts; 

l'epres('nta tiy('s of patient and ('OIlSnlllt'l' ad\'(l('(l('Y g:roups; and 

the rt'g111ated industry. 

Pmm( PI'BLlC L',prT,-Priol' to beg'inning 

with the l'egnlated industry on tlw l'PlHl12 

13 

14 

15 

16 

17 

18 

19 

20 

thol'lzatioll of this tIl(' Se(,l'l'tnI',Y shall21 

22 

23 

24 

f:WHLCI0402131040213,115,xm! 

April 2, 2013 (5:10 p,m,) 

]lnblish 11 notie" in the Federal Register publie input 011 the reauthorizatiOll; 

hold a publie meetillg at whieh tllp 

public' ll1a~- presellt its YIt"YS on the reauthorizntion, inc~ludillg for dumgp~ 

to tIE' referred to ill ~nbsedioll 

JlHIllie mE'r>tillg to obtain ,Yl'itten ('omnwnt~ from 

the pllblie to tbis part; and 

"(D) publish the eOlnnwuts on th(' l"oo(] 

and Admini~trati()n's Internet \\'eb sitt'. 

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2 qm·ntl." than oncE' pypry -± montlls during tlPgotia3 tiews ,,,jtll thE' rpgulah'd illdnstr.", the SeCl'etHl":,,' shall 

4 hold diseussions \rith repr('sentatiYes of wterinary, 

5 patient, and consnmer adyoeney gTonps to continue 

6 disenssiol1s of their yjews on the reauthorizatioll and 

7 their snggestions for ehallges to this part as ex8 prcssea under paragraph (2). 

9 

10 TIO:-\8.-Aftel' IH'gotintiollS 'with the reg11lated indus11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

f:WHLC\040213\040213.115.xml 

April 2, 2013 (5:10 p.m.) 

, the shalloped lH](jel' paragraph (1) to the eongres;.;ional 

eommittees QnOOl,t'"',,I in snell paragTaphi 

publish sueh re('ommel1(iatiolls in the 

Pederal Heg-istel'; 

"(C) pl'mide for a period of :30 for 

the publie to pf'oyide writh'll l'omments on sneh 

reeOlmllel1(lations; 

"(D) hold a at whi('h the publie 

may pl'est-Ilt its yieli's Oil sHell l'eeonnnendatiolls; and 

after ('ollsiderntion of suell pnblie 

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F:\M 1 3\GARDNE\GARDNE_O 1 O.xML 

2 ::\ot later than .Jmm<1I'Y 1o, 2018, the 8pl'retar~' 

3 shall transmit to the reyised reeomnwnda4 bons under parnl-'Taph (4), a snmmm,;\- of the yiews 

5 and eomments l'eeeiYl'd under sHch paragraph, and 

6 nll~' ehanges made to the l'e('ommendations in re7 spOllse to such Ylt'WS and C'omnwllts. 

8 :\IL'\TTER 01<' :\EGOTlATIO:\ :\lEETI:\OS.-

10 sPllting: the l'eeommelldatiolls dewlope>d nnde]' 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

fWHLC\040213\040213.115.xml 

April 2. 2013 (5:10 p.m.) 

(1) through to COllgre'ss, the 

8eeretary shall make pllblidy amilable, on the 

Internet 'I'd} site' of the Food and Dmg' Administration, minutes of all negotiation meetings eondneted nnder this suhseetion betIYeen 

the Food ami Drug Aclmillistration and the regnlated indusil,;\-. 

"(B) CO:\TE:\T.-'I'he minutes d(~sel'ibed 

under subparagraph shall summarize any 

snilstantiy(' proposal llHHle by an~- party to thE' 

negotiations as weJl as signifieant eontrowrsiE's 

or differenees of opinion durillg tbe uegotiHtiolls 

HDd their resolntioll,". 

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SEC. 4. SAVINGS CLAUSE. 

2 :'\ot\\ithstandillg the all1('ndments lllHdt' by this Ad, 

3 part;) of snlwhaptt'l' C of ('hapter \11 of the Ft'deral Food, 

4 Drug" and Cosm('ti(' ;\.('1. as ill effeet on the day before 

5 the (iatt' of elladmellt of this ;\.et, shall eontimw to be 

7 J1I"1'ie ll(,\\' animal dmg and supplemental abbn,yiated ap8 plieatiolls for a nt'w animal drug d"fin('(\ in 

9 suell part as of s11eh <1n:,) that OJl 01' after Oetober 1, 2008, 

10 hut bt'fort' Oet01wI' I, 201:l, IWl't' by the Food 

11 and Dmg' Administration for filillg "ith !'espt>C't to assess12 lng aud eolledillg any fee reqnired by sHeh part for a fisenl 

14 SEC. 5. EFFECTIVE DATE. 

]5 TIlt' tllllE'udnwnts made this .. 1et shall iakt' d'feet 

16 on OetobeI' 1, 201:;, or tlte datE' of enaetment of this 

17 IYhie!lpyel' is lajPl" E'xeept that fees ll11d('1' part;) of sub18 C of ehaptp1' \11 of tIle F"dpra] 1"00<1, Drug, and 

19 Cosllwtie Aet, as HllwlHjed b~" this Aet, shall be asspsspd 

20 for all abbreyiated applieations for a g'e'lwrie ]lew anililal 

21 aIld snpplpHlPutal ahbn'I'inted applieations for 1\ g('-

22 11Pl1(, 1l(Y\Y animal 

23 20U, l'egardlpss of the date of C'llaetmeut of this Aet. 

f:IVHlCI0402131040213.115.xml 

April 2, 2013 (5:10 p.m.) 

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80810.104

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SEC. 6. SUNSET DATES. 

2 Al"l'IlOm;;;XrIo:\.-Scetion 741 of the Federnl 

3 Food. Dmg', and Cmmwtie ..:\('t FRC. ~n9j-21) shall 

4 ('easp to he ('ffeetin: Oetober 1. 2018. 

5 (b) HEl'ORTI:\(i REQrmE:ilE:\'rs.-Se('tioll 742 oftlw 

6 Federal Food. Drug, and CosHletie Aet FS.C. :37!)j7 22) shall eease to be effl'etiw .Tmmary 81, 20H). 

8 PngYIOl-S Sr:\sET PHOYlSlO:\.-

9 (1) 1:\ OE,:\EIL\L.-Seetioll 204 of the r\J.limal 

10 Generie Drug e ser Ft'{' Act of 2008 {puhlic Law 

11 110-:11G) is l'epeahL 

12 CO:\FOlUU:\(i .\:iIE:\JnIE:\T.-The Animal 

13 Gellt'rie Drl1g' F ser Fp{, ..:\('t of 2008 (Puhlie Law 

14 11 0-:31 (i) is anwndell in the table of ('ontents in see15 

f:\VHLC\040213\040213.115.xmi 

April 2, 2013 (5:10 p.m.) 

tion 1, b,\-

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the item to sl'etion 204. 
67 

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH 

OF PENNSYLVANIA 

Mr. PITTS. In 2003, ADUFA I was authorized to help the Food 

and Drug Administration review of animal drugs. Similar to the 

prescription drug user fee for human drugs, under ADUFA, FDA 

collected funds to expedite the new animal drug approval process, 

reduce the application backlog and improve communications with 

drug sponsors. The program was authorized for 5 years, and Congress renewed the program for an additional 5 years in ADUFA II 

in 2008. 

In fiscal year 2012, FDA completed 747 ADUFA reviews. And according to FDA, the agency has exceeded all performance goals outlined in ADUFA I and II. However, absent congressional action, 

FDA’s ability to collect these user fees will expire September 30, 

2013. 

FDA and industry have negotiated an agreement regarding the 

size and scope of ADUFA III, which would extend the program 

through fiscal year 2018, and these recommendations were delivered to the committee in February. Under the negotiated proposal 

industry would pay approximately $23.6 million in fiscal year 2014 

and similar amounts adjusted for inflation for fiscal years 2015 to 

2018. Twenty percent of this total would come from application 

fees, 27 percent from product fees, 27 percent from sponsor fees, 

and 26 percent from establishment fees. The ADUFA III proposal 

also includes an annual offset adjustment based on any collection 

shortfall in previous years. 

AGDUFA I, ADUFA’s generic cousin, was first authorized in 

2008 for 5 years in order to improve the review of abbreviated new 

animal drug applications, eliminate application backlogs and reduce review times. To date, according to the FDA, the agency has 

exceeded all performance goals but one from AGDUFA I. This program also expires September 30, 2013, unless it is reauthorized, 

and FDA and industry have negotiated an agreement for AGDUFA 

II. 

Under the proposed AGDUFA II agreement, industry would pay 

$7.3 million in fiscal year 2014, which allows for hiring of 22 FTEs 

and includes a one-time cost of $850,000 for information technology; $6.9 million for fiscal year 2015; $7.4 million for fiscal year 

2016; $7.9 million for fiscal year 2017; and $8.4 million for fiscal 

year 2018. These fees would be paid through application fees, 25 

percent of the total; product fees, 371⁄2 percent; and sponsor fees, 

also 371⁄2 percent of the total. 

The legislation to reauthorize ADUFA III was introduced today 

by Congressman John Shimkus, and the AGDUFA II reauthorization sponsored by Representative Cory Gardner was also introduced today. 

I want to welcome all of our witnesses, thank them for being 

here today, look forward to your testimony. We have a new set of 

lights, and so green is go with your statement, a 5-minute statement. Yellow I think there is 30 seconds left. Red is you are over 

time. So thank you. 

[The prepared statement of Mr. Pitts follows:] 

68 

PREPARED STATEMENT OF HON. JOSEPH R. PITTS

The Subcommittee will come to order. 

The Chair will recognize himself for an opening statement. 

Today’s hearing focuses on the reauthorization of two successful programs—the 

Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act 

(AGDUFA). 

In 2003, ADUFA I was authorized to help the Food and Drug Administration’s 

(FDA) review of animal drugs. 

Similar to the Prescription Drug User Fee for human drugs, under ADUFA, FDA 

collected funds to help expedite the new animal drug approval process, reduce the 

application backlog and improve communications with drug sponsors. 

The program was authorized for 5 years, and Congress renewed the program for 

an additional 5 years in ADUFA II in 2008. 

In FY2012, FDA completed 747 ADUFA reviews, and, according to FDA, the agency has exceeded all performance goals outlined in ADUFA I and II. 

However, absent Congressional action, FDA’s ability to collect these user fees will 

expire September 30, 2013. 

FDA and industry have negotiated an agreement regarding the size and scope of 

ADUFA III, which would extend the program through FY2018, and these recommendations were delivered to the Committee in February. 

Under the negotiated proposal, industry would pay approximately $23.6 million 

in FY2014, and similar amounts, adjusted for inflation, for FYs 2015–2018. 

Twenty percent of this total would come from application fees, 27% from product 

fees, 27% from sponsor fees, and 26% from establishment fees. 

The ADUFA III proposal also includes an annual offset adjustment based on any 

collection shortfall in previous years. 

AGDUFA I, ADUFA’s generic cousin, was first authorized in 2008 for 5 years, in 

order to improve the review of abbreviated new animal drug applications 

(ANADAS), eliminate application backlogs, and reduce review times. 

To date, according to FDA, the agency has exceeded all performance goals but one 

from AGDUFA I. 

This program also expires September 30, 2013 unless it is reauthorized, and FDA 

and industry have negotiated an agreement for AGDUFA II. 

Under the proposed AGDUFA II agreement, industry would pay: 

• $7,328,000 in FY2014 (which allows for the hiring of 22 FTEs and includes a 

one-time cost of $850,000 for information technology); 

• $6,944,000 in FY2015; 

• $7,429,000 in FY2016; 

• $7,936,000 in FY2017; and 

• $8,467,000 in FY2018. 

These fees would be paid through application fees (25% of the total), product fees 

(37.5%), and sponsor fees (also 37.5% of the total). 

The legislation to reauthorize ADUFA III was introduced today by Rep. John 

Shimkus, and the AGDUFA II reauthorization, sponsored by Rep. Cory Gardner, 

also was introduced today. 

I want to welcome all of our witnesses and thank them for being here today. I 

look forward to your testimony. 

Thank you. At this time, I would like to request unanimous consent for Congressman Gardner to participate in the subcommittee hearing. Without objection so ordered. I now yield the remainder of my time to Rep. Gardner. 

Mr. PITTS. At this time I would like to request unanimous consent for Congressman Gardner to participate in the subcommittee 

hearing. Without objection, so ordered. 

I now yield the remainder of my time to Representative Gardner. 

OPENING STATEMENT OF HON. CORY GARDNER, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF COLORADO 

Mr. GARDNER. Thank you, Mr. Chairman, and I thank you for allowing me to be here today; Ranking Member Pallone and other 

colleagues on the subcommittee for the opportunity to participate 

today. And I would also like to congratulate Congressman Shimkus 

69 

for his introduction of the Animal Drug User Fee Amendments Act 

of 2013. 

My congressional district is home to over 2.8 million head of 

cows, 450,000 hogs and pigs, and close to 160,000 sheep and goats. 

There is far more livestock in my district than there are people. At 

least that is what they tell me in Colorado. But, in fact, the State 

of Colorado is the fifth largest State in the Nation when it comes 

to cattle on feed. 

The ADUFA and AGDUFA programs have been a success at 

FDA, and the continuation of these important programs will ensure 

that livestock producers in Colorado and indeed throughout the 

country will continue to have access to safe and effective animal 

drugs to treat their herds. 

In particular, the Animal Generic and Drug User Fee Program 

at FDA has achieved noteworthy success since first being authorized in 2008. FDA decreased a significant backlog of applications 

and reduced the review time for new animal drug applications. The 

reauthorization of AGDUFA will continue this progress at FDA and 

other—and our producers with cost-effective generic products that 

are available to the market on the market faster. 

It is an honor to have the opportunity to lead the reauthorization 

of AGDUFA through this committee, and I look forward to working 

with my colleagues to ensure its passage and to hearing from the 

witnesses today. And with that, Mr. Chairman, thank you, and I 

yield back the balance of my time. 

Mr. PITTS. The chair thanks the gentlemen, and now recognizes 

the ranking member of the subcommittee Mr. Pallone for 5 minutes 

for his opening statement. 

OPENING STATEMENT OF HON. FRANK PALLONE JR, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY 

Mr. PALLONE. Thank you, Mr. Chairman. 

I am pleased that the committee is having a hearing on two important bills today, the Animal Drug User Fee amendments and 

the Animal Generic Drug User Fee amendments, both of which I 

have cosponsored. Without congressional action the current agreements will expire at the end of this fiscal year, which would have 

a serious and harmful impact on the ability of FDA’s Center for 

Veterinary Medicine to review new and generic drug applications 

in a timely manner. 

Prior to 2003, FDA’s review of animal drug submissions was taking over a year and a half to be completed, and this obviously led 

to serious concerns that new and innovative pharmaceutical products were not making their way on to the marketplace in order to 

treat our Nation’s pets, as well as food animals that help sustain 

the Nation’s food supply. Accordingly in 2003, Congress first enacted ADUFA to help improve the FDA review of new animal 

drugs. 

Like other user fee programs for human drugs, ADUFA authorized the FDA to collect fees to help ensure that the agency had the 

resources it needed to help expedite the new animal drug approval 

process, reduce the application backlog and improve communications with drug sponsors. 

70 

In 2008, because of the success of this program, Congress reauthorized ADUFA for 5 years—that is ADUFA II—and so here we 

are again 5 years later. In order for the FDA to continue the success of this program, Congress must act to reauthorize these user 

fees. 

Under the proposed ADUFA III agreement, the industry would 

pay approximately $23.6 million in fiscal year 2014 and similar 

amounts in the remaining 4 years based on inflation adjusters. 

This includes some resources for technology infrastructure in the 

first year. These fees will continue to allow the agency to more efficiently and effectively review an animal drug applications and provide industry with predictability and speedier reviews. 

In 2008, Congress authorized the AGDUFA program for 5 years 

in order to improve the review of abbreviated new animal drug applications or generic versions of animal drugs. AGDUFA enabled 

the agency to eliminate its application backlog and reduce review 

times. Similar to ADUFA, FDA and industry negotiated an agreement regarding the size and scope of an agreement for generic animal drugs, or AGDUFA. 

Under the new proposal before us today, the industry would pay 

$7.3 million in fiscal year 2014, which includes technology funding; 

6.944 million in fiscal years 2015; 7.429 million in fiscal year 2016; 

7.936 million in fiscal year 2017; and, finally, 8.467 million in fiscal 

year 2018. Once implemented, AGDUFA will continue to speed 

lower-cost animal drugs to the marketplace and bring significant 

savings to ranchers, farmers, and pet owners. 

I think we can all agree that these programs have been particularly effective. This project should not be interrupted, and so, Mr. 

Chairman, I stand ready to work with you so that this process will 

be expeditious, and we can pass these agreements into law as soon 

as possible. 

Let me close by saying that I recognize that there is a growing 

concern among stakeholders and some members of the subcommittee about the use of antibiotics in food animals. Clearly we 

face significant challenges when it comes to maintaining the effective use of antibiotics. With fewer and fewer innovative antibiotic 

products coming down the pharmaceutical pipeline, it is even more 

important that we keep antibiotics that are currently on the market working. So I look forward to hearing from our second panel 

about how bacteria that are resistant to antibiotics begin to proliferate, and what type of threat this poses to humans. 

So thank you again for all the witnesses for being with us, and 

we are looking forward to your testimony. 

Nobody wants my time, right? No. I yield back. 

Mr. PITTS. The chair thanks the gentlemen. 

I now recognize the chairman of the full committee Mr. Upton for 

5 minutes for an opening statement. 

OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN 

Mr. UPTON. Well, thank you, Mr. Chairman. I appreciate today’s 

hearing on the reauthorization of the Animal Drug User Fee Act, 

as well as the Animal Generic Drug User Fee Act. 

71 

You know, Congress first created ADUFA back in 2003 and 

AGDUFA back in 2008, and together these programs have yielded 

many benefits for the American people, and they have ensured that 

veterinarians, livestock producers, poultry producers, pet owners 

have access to new and affordable animal drugs to keep their animals healthy. They have assisted animal drug producers by fostering a stable and predictable FDA review process. And finally, 

they have helped American consumers by keeping that food supply 

safe. For companies like Zoetis, which employs over 700 people in 

my district, these programs are essential for them to keep producing top-of-the-line drugs for pets and livestock. 

I was fortunate enough to be the lead House sponsor of the original ADUFA bill back in 2003, and it is great to see how successful 

it has been and how many Americans it has, in fact, helped. I believe that there is a bipartisan, bicameral interest in getting these 

user fees reauthorized well before they expire at the end of September of this year, and I intend to do all that I can to make sure 

that that effort happens. So I look forward to working with all of 

our colleagues on those bills. I want to particularly thank Mr. 

Gardner and Mr. Shimkus for their leadership on both of these 

pieces of legislation respectively, and I yield the balance of my time 

to John Shimkus. 

[The prepared statement of Mr. Upton follows:] 

PREPARED STATEMENT OF HON. FRED UPTON

Thank you for holding today’s hearing on the reauthorization of the Animal Drug 

User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA). 

Congress first created ADUFA back in 2003 and AGDUFA in 2008. Together, 

these programs have yielded many benefits for the American people. They have ensured that veterinarians, livestock producers, poultry producers and pet owners 

have access to new and affordable animal drugs to keep their animals healthy. They 

have assisted animal drug producers by fostering a stable and predictable FDA review process. Finally, they have helped American consumers by keeping the food 

supply safe. 

For companies like Zoetis, which employs over 700 folks in my district, these programs are essential for them to keep producing top of the line drugs for pets and 

livestock. 

I was fortunate enough to be the lead House sponsor of the original ADUFA legislation in 2003, and it is great to see how successful it has been and how many 

Americans it has helped. 

I believe there is bipartisan, bicameral interest in getting these user fees reauthorized well before they expire at the end of September. I intend to do all I can 

to make this reauthorization effort bipartisan, and I look forward to working with 

my Democratic colleagues on these bills. 

I thank John Shimkus and Cory Gardner for their leadership on ADUFA and 

AGDUFA, respectively. 

OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS 

Mr. SHIMKUS. Thank you, Mr. Chairman. Thank you also, Chairman Pitts, and I appreciate holding this hearing on the user fee reauthorization bills that are important to our agriculture community 

and the consumers they serve. 

Today I am pleased to introduce legislation reauthorizing the 

Animal Drug User Fee Act, along with companion legislation to reauthorize generic drug user fees, introduced by my colleague from 

Colorado Cory Gardner. Together these bills will provide the FDA 

72 

with critical resources to improve the animal drug approval process 

and allow drug manufacturers to bring innovative products to the 

market, improving food safety and animal health. These are the 

same tools the FDA has successfully utilized to reduce application 

backlogs and provide a more predictable process since ADUFA was 

first signed into law over 10 years ago. 

ADUFA is important to many of my constituents in southern Illinois as well as rural and agricultural communities across the country. It is a fact of life that animals get sick, and it is important for 

veterinarians to have the ability to provide the best drugs and 

treatment available. H.R. 1407 and 1408 provide veterinarians access to products to prevent, control and treat animal diseases in 

our pets and livestock. 

Livestock producers benefit as well. Last week when I announced 

the introduction of ADUFA reauthorization, I stood with beef and 

pork producers from my district who spoke on the importance of 

this legislation to their businesses and livelihoods. They rely on the 

timely availability of these drugs to provide a safe food product to 

maintain the health of their herds. 

At the end of the day, all American consumers benefit from the 

availability of safe and affordable food. This will have positive impact on everyone in our district, from producers on family farms to 

pet owners and consumers in major urban cities and suburbs 

around the country. 

I want to thank Chairmen Upton and Pitts, along with Ranking 

Member Waxman and Pallone for becoming original cosponsors of 

these reauthorizations, and I look forward to working with them to 

move these bills through the committee. I believe the hearing today 

will be a productive next step for us to move forward on swift bipartisan passage of H.R. 1407 and 1408 through the House. 

Thank you to our witnesses from the FDA and the animal health 

community for being here today. I look forward to hearing your 

input on the importance of a clean reauthorization process. 

With that, Mr. Chairman, I yield back the balance of my time. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the ranking member of the full committee Mr. Waxman, 5 minutes 

for an opening statement. 

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Mr. WAXMAN. Thank you very much, Mr. Chairman. 

Our hearing today is going to examine FDA’s animal drug user 

fee programs, which have been successful at speeding both brand 

and generic drugs for animals to the market, and that is very important. But the reauthorization of these user fee programs also 

gives us an opportunity to look at providing FDA with new tools 

to address a glaring public health crisis, the problem of antibiotic 

resistance. 

Antibiotics are truly a lifesaving gift. Unfortunately the more 

they are used, the less they work. Untold numbers of Americans 

die or are infected each year by antibiotic-resistant bugs. To remain effective, antibiotics must be used judiciously. To be sure, 

antibiotics are overprescribed for use in humans. That is a real and 

73 

difficult problem and one that requires our attention. But we have 

to look at all areas in which antibiotics are used and reduce all unnecessary uses. 

We know that most antibiotic use occurs on the farm, and much 

of this use is not to treat sick animals, which everyone agrees is 

important, but for disease prevention or growth promotion. Unfortunately we don’t know exactly how much because it isn’t reported 

anywhere. 

We now have an overwhelming body of evidence showing that 

the overuse of antibiotics in industrial meat production is threatening to destroy the effectiveness of our most important antibiotics 

for human use. In recent years reports from the Institute of Medicine, GAO and the World Health Organization all describe the global public health threat generated by bacteria that had become resistant as a result of antibiotic use on the farms. 

There is a bill that would take steps to curtail the inappropriate 

use of important human antibiotics. Representative Slaughter’s 

Preservation of Antibiotics for Medical Treatment Act, or PAMTA. 

We always take these things and put them down as acronyms. This 

bill has a long history. Congressman Dingell and I introduced the 

very first version back in 1980 as The Antibiotics Preservation Act. 

I think this legislation makes good sense, but it has, unfortunately, never moved very far. At least part of the reason it has 

failed to move is that industry claims there is not enough data to 

show a link between the use of antibiotics on the farm and the development of resistant bugs that harm people. That is why we need 

to ask industry to give us more data on how these drugs are being 

used. Industry should provide evidence to document its assertion 

that there is no link. Industry should not be able to have it both 

ways. We know a lot about how antibiotics are being used in humans thanks to our healthcare system infrastructure. We know 

very little about the use of antibiotics on farms and ranches. 

In the 2008 reauthorization of the animal drug user fee legislation, we took a sensible step by requiring drug companies to make 

certain limited reports to FDA on their animal antibiotics sales 

data, but we need to go further. Earlier this year I introduced the 

Delivering Antibiotic Transparency in Animals Act, or DATA. The 

DATA Act would enhance the information FDA gets about how 

these drugs are used by putting modest requirements on the drug 

companies and the major industrial meat product companies like 

Tyson or Smithfield Farms. 

This is a commonsense bill. There is no prohibition on the use 

of these drugs. We are simply asking that industry tell us more 

about the way these drugs are used so that we can learn more 

about how resistant bugs which are harming Americans every day 

are bred. 

The issue of antibiotic resistance is not new to this committee. 

In the 111th and 112th Congresses, we held several hearings on 

this issue. Now is the time for the next step by moving the DATA 

Act as we work to combat the public health crisis. 

I understand the argument for keeping the Animal Drug User 

Fee Acts free of controversy, but I do think we need to find a way 

to address this issue soon. We need to ensure that FDA has not 

only the resources and procedures for speeding safe and effective 

74 

animal drugs to market, but also the information to ensure that 

they are being used judiciously. 

I thank you, Mr. Chairman, for holding this hearing today. I look 

forward to the hearing, hearing from our witnesses, and I yield 

back a second, the 3, 4 seconds I don’t have any longer. 

Mr. PITTS. The chair thanks the gentlemen. 

That concludes the opening statements by the Members. We have 

two panels today. I will ask the first panelist to please come forward to the witness table and introduce her at this time. 

Dr. Bernadette Dunham, Director of the Center for Veterinary 

Medicine, U.S. Food and Drug Administration, is our first witness. 

Thank you for coming. You will have 5 minutes to summarize your 

written testimony. Your written testimony will be made part of the 

record. And so at this time, Dr. Dunham, you are recognized for 5 

minutes. 

STATEMENT OF BERNADETTE DUNHAM, DIRECTOR, CENTER 

FOR VETERINARY MEDICINE, U.S. FOOD AND DRUG ADMINISTRATION 

Dr. DUNHAM. Thank you very much. 

Good afternoon, Chairman Pitts, Ranking Member Pallone and 

members of the subcommittee. I am Dr. Bernadette Dunham, Director of the Center for Veterinary Medicine at the Food and Drug 

Administration. Thank you for this opportunity to discuss FDA’s 

proposals for reauthorization of the Animal Drug User Fee Act and 

the Animal Generic Drug User Fee Act. 

As you know, these fee programs are designed to expedite access 

to new therapies for food-producing animals and companion animals, and foster innovation in drug development by enabling FDA 

to maintain a stable workforce to provide a predictable and timely 

review process. 

These programs have been highly successful and have enabled 

FDA to eliminate a backlog in application, dramatically reduce the 

time needed to review animal drug applications and other submissions, improve timely communications with drug sponsors, and 

achieve other efficiencies in the drug approval process, while still 

ensuring the drugs are safe and effective. 

In my testimony today I will provide the status of FDA’s reauthorization activities. I will also provide some information about 

each program, our achievements to date, and our proposed changes. 

The user fee provisions of ADUFA II and AGDUFA I will sunset 

on October 1st, 2013, if not reauthorized. Timely reauthorization is 

needed to ensure there is it no disruption to these important programs. 

FDA began the reauthorization process with the public meeting 

held November 7th, 2011, and began discussions with stakeholders 

in February 2012. FDA published the negotiated recommendations 

in the Federal Register on December 5th, 2012, and solicited public 

comment. Another public meeting to get input on the recommendations was held December 18th, 2012. The final recommendations 

transmitted to Congress include for each program the goals letter 

outlining the performance metrics, the proposed legislative language, and a summary of public comments. 

75 

FDA considers the timely review of the safety and effectiveness 

of new animal drug applications to be central to the agency’s mission to protect and promote public health. Under the original Animal Drug User Fee Act enacted in 2003, the agency agreed to meet 

a comprehensive set of performance goals established to show significant improvement in the timeliness and predictability of new 

animal drug review process. The additional funding enabled FDA 

to increase the number of review staff by approximately 30 percent. 

In 2008, before ADUFA I expired, Congress passed ADUFA II, 

which included an extension of the program for an additional 5 

years. And I am pleased to report that FDA has exceeded all of the 

performance goals established under ADUFA for each year of this 

critical program. 

During the first 5 years of the program, the agency was able to 

dramatically reduce review times from 500 days to 180 days and 

completely eliminate the backlog of 833 submissions within the 

first year. 

Due to the current success of the program, FDA and industry 

agree that only minor refinements to the performance goals that 

ADUFA II established were necessary. Our recommendations relating to the financial enhancements of this program include a new 

statutory inflation adjuster, a new provision for recovering collection shortfalls, and a modification of the workload adjuster. 

To increase revenue stream stability, reduce application fee costs 

and minimize the potential for collection shortfalls, the recommendations also modify the fee revenue distribution. FDA’s recommendation to Congress after consultation with the regulated industry is that the total fee revenue estimate for fiscal year 2014 

will be $23.6 million, which includes a one-time information technology funding in the amount of $2 million. 

AGDUFA I authorized FDA’s first-ever generic animal drug user 

fee program, and the additional funding enabled FDA to increase 

the number of review staff by approximately 45 percent. Furthermore, the authorization of AGDUFA I enabled FDA’s continued assurance that generic animal drug products are safe and effective, 

and provided pet owners, ranchers and farmers with greater access 

to lower-cost therapeutic drugs. FDA agreed to meet performance 

goals to expedite the review of generic applications and submissions without compromising the quality of the agency’s review. 

During the 4 years of AGDUFA I, FDA has exceeded every goal 

every year, with one minor exception. We missed a performance 

goal by 1 day for one submission of an investigational generic new 

animal drug in 2009. 

The additional resources provided under AGDUFA I enabled 

FDA to completely eliminate a backlog of 680 submissions in 22 

months. In addition, the agency has been able to dramatically reduce review times from 700 days to 270 days. 

FDA’s goals for AGDUFA II are to sustain and enhance the core 

program’s operation and performance, while providing predictable 

review times and resources sufficient to keep pace with actual 

costs. FDA and industry agreed to shorter review times for certain 

reactivations and resubmissions and to implement a process for 

timely foreign inspections. 

76 

Our recommendations for financial enhancements for AGDUFA 

II include a fixed inflation adjuster of 4 percent each year to 

achieve the proposed revenue levels, and modification of the workload adjuster to ensure that it adequately captures FDA’s workload. We also recommend modifying the fee revenue distribution to 

increase the stability of the revenue stream and reduce application 

fee costs. 

The total 5-year revenue for AGDUFA I was $27.1 million. The 

proposed total 5-year revenue for AGDUFA II will be $38.1 million, 

which includes a one-time IT funding for $850,000 for fiscal year 

2014 for the first year planned of a total of $7.328 million. 

FDA’s ADUFA and AGDUFA legislative proposals represent considerable input from and agreement of stakeholders, the public, 

and the agency. ADUFA and AGDUFA are widely regarded as extremely successful programs. The recommendations we have submitted for reauthorization of these programs will ensure FDA has 

a stable workforce to provide the predictable and timely review 

process the drug sponsors need in order to foster innovation. They 

will also provide for expedited access to new therapies for food-producing animals and companion animals, while ensuring the drugs 

are safe and effective. 

Thank you for the opportunity to discuss ADUFA and AGDUFA 

programs, and I am happy to answer any questions. 

Mr. PITTS. Thank you, Dr. Dunham, for your opening statement. 

[The prepared statement of Dr. Dunham follows:] 

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#'1 .... ~~" ( 4. DEPARTMENT OF HEALTH AND HUMAN SERVICES 

:::j Food and Drug Administration 

Silver Spring, MD 20993 

STATEMENT 

OF 

BERNADETTE M. DUNHAM, D.V.M., PH.D. 

DIRECTOR, CENTER FOR VETERINARY MEDICINE 

FOOD AND DRUG ADMINISTRATION 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

BEFORE THE 

SUBCOMMITTEE ON HEALTH 

COMMITTEE ON ENERGY AND COMMERCE 

U.S. HOUSE OF REPRESENTATIVES 

APRIL 9, 2013 

FOR RELEASE ONLY UPON DELIVERY 
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INTRODUCTION 

Good afternoon, Chairman Pitts, Ranking Member Pallone, and Members of the 

Subcommittee. I am Dr. Bernadette Dunham, Director of the Center for Veterinary Medicine 

(CVM) at the Food and Drug Administration (FDA or the Agency), which is part of the 

Department of Health and Human Services (HHS). Thank you for the opportunity to discuss 

FDA's proposals for the reauthorization of the Animal Drug User Fee Act (ADUFA III) and 

the Animal Generic Drug User Fee Act (AGDUFA II). 

As you know, these fee programs are designed to expedite access to new therapies for foodproducing animals and companion animals and foster innovation in drug development by 

enabling FDA to maintain a stable workforce to provide a predictable and timely review 

process. These programs have been highly successful and have enabled FDA to eliminate a 

backlog in applications, dramatically reduce the time needed to review animal drug 

applications and other submissions, improve timely communications with drug sponsors, and 

achieve other efficiencies in the drug approval process, while still ensuring that the drugs are 

safe and effective. 

In my testimony today, I will provide the status of FDA's reauthorization activities. I will 

also provide some information about each program, our achievements to date, and our 

proposed changes. 
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STATUS OF FDA'S REAUTHORIZATION ACTIVITIES 

The user fee provisions of ADUFA II and AGDUFA I will sunset on October 1,2013, ifnot 

reauthorized. Timely reauthorization is needed to ensure there is no disruption to these 

important programs. FDA began the reauthorization process with a public meeting held on 

November 7, 2011. In February 2012, FDA began discussions to get input from our 

stakeholders to help us develop our recommendations for reauthorization. FDA consulted 

with representatives of patient and consumer advocacy groups, veterinary professionals, 

scientific and academic experts, and industry associations. FDA then published the 

negotiated recommendations in the Federal Register (FR) on December 5, 2012, and solicited 

public comment. We also held a second public meeting to get input on the recommendations 

on December 18, 2012. The final recommendations transmitted to Congress include, for each 

program, the goals letter outlining the performance metrics, the proposed legislative language, 

and a summary of public comments. 

ADUFA BACKGROUND 

FDA considers the timely review of the safety and effectiveness of new animal drug 

applications (NADA) to be central to the Agency's mission to protect and promote public 

health. One way we protect animal and human health is by approving safe and effective and 

properly labeled new animal drugs. Prior to 2004, the timeliness and predictability of the new 

animal drug review program was a concern. The original Animal Drug User Fee Act enacted 

in 2003 (ADUF A I) authorized FDA to collect user fees that were to be dedicated to 

expediting the review ofNADAs in accordance with certain performance goals and to expand 

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and modernize the new animal drug review program. The Agency agreed, under ADUF A I, 

to meet a comprehensive set of performance goals established to show significant 

improvement in the timeliness and predictability of the new animal drug review process. The 

implementation of ADUF A I provided a significant funding increase that enabled FDA to 

increase the number of staff dedicated to the review of animal drug applications by 

approximately 30 percent since 2003. 

In 2008, before ADUF A I expired, Congress passed ADUF A II, which included an extension 

of the program for an additional five years (FY 2009 to FY 2013), as well as several 

enhancements to the program. 

ADUFA ACHIEVEMENTS 

I am pleased to report that FDA has exceeded all of the performance goals established under 

ADUF A for each year of this critical program. Under the performance goals of ADUF A, 

FDA agreed to review and act on submissions within shorter periods of time each successive 

year. During the first five years ofthis program, the Agency was able to dramatically reduce 

review times from 500 days to 180 days and completely eliminate a backlog of833 

submissions within the first year. 

With ADUF A II, FDA agreed to further enhance the review process. A key improvement 

under ADUF A II is the "end-review amendment" (ERA) process that allows FDA reviewers 

to work with the drug sponsor to amend certain pending submissions. By enhancing 

communication early in the process, the ERA process aIlows FDA to decrease the number of 

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review cycles, which ultimately leads to a shorter time to approval and significant costsavings for the sponsor. The greatest impact of this new tool has been with submissions of 

investigational new animal drug (INAD) studies and study protocols. Greater than 90 percent 

of ERAs resulted in a favorable outcome in the first cycle. 

Also as part of ADUFA II, FDA developed an electronic submission tool, which has enabled 

sponsors to submit applications and submissions electronically, allowing FDA reviewers to 

evaluate the submissions and correspond with sponsors electronically. Electronic submissions 

have provided substantial cost savings for both FDA and animal drug sponsors. 

Approximately 18 percent of submissions were electronic in 20 11, the program's first year, 

and over 50 percent were electronic in 2012. Submissions are received by FDA in minutes 

rather than days, and correspondence back to sponsors occurs in minutes rather than the 

several days required for mailing responses. 

Further, FDA and the regulated industry participated in eight joint public workshops on 

mutually agreed-upon topics. This collaboration enhanced communication and transparency 

on topics critical to the animal drug review process. The workshops discussed in detail the 

data requirements necessary for drug evaluation and explored scientific approaches to 

challenges in pharmacokinetics, new emerging issues relative to antiparasitic resistance, and a 

novel question-based-review (QbR) process for certain reviews. The final two public 

workshops for FY 2013 will address the evaluation of drugs for use in animal production and 

data quality for animal drug submissions from sponsors. 

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ADUFA II also enabled FDA to improve the animal drug review and business processes by 

facilitating the timely scheduling and conducting of foreign pre-approval inspections. 

Because of processes developed under ADUF A II, sponsors are now able to voluntarily 

submit an annual facilities list and notification 30 days prior to submitting an NADA, a 

supplemental NADA, or an INAD submission to inform FDA that the application or 

submission includes a foreign manufacturing facility. This advance notice gives FDA more 

time to plan for any necessary foreign inspections, thus helping to reduce costs and prevent 

delays during the review of an application or submission. 

PROPOSAL FOR ADUFA III 

FDA is proposing changes to the performance goals that ADUF A II established to further 

enhance the process for review of animal drug applications. Due to the current success of the 

program, FDA and industry agreed that only minor refinements were necessary. 

The ERA procedure implemented as part of ADUF A II resulted in an increase in the number 

of one-cycle reviews; however, certain challenges associated with the process restricted its 

full utilization. The Agency is proposing, among other changes, to further improve the review 

process by replacing the ERA with shorter review times for certain resubmissions and 

reactivations beginning in FY 2015. To allow time for the programming and information 

management system changes required to make this and other changes, we are proposing to 

maintain the ADUFA II ERA process and associated review performance goals for FY 2014 

for most applications. 

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FDA agrees to maintain the ADUF A n performance goals regarding work queue procedures, 

timely meetings with industry, review of administrative NADAs, and pre-approval foreign 

inspections. To enhance the exchange of scientific information, the Agency and industry 

agree on the need for industry to submit information earlier in development to enable the 

parties to reach agreement at a pre-submission conference or begin the review of study 

protocols. Additionally, FDA will provide increased flexibility for sponsors to submit 

scientific data or information concurrent with study protocol review. 

Our recommendations relating to the financial enhancements ofthis program include a new 

statutory inflation adjuster that accounts for changes in FDA's costs related to payroll 

compensation and benefits as well as changes in non-payroll costs through use of a prescribed 

methodology that uses the Consumer Price Index as a guide. We also recommend modi lYing 

the base years for calculating the workload adjuster to ensure that it adequately captures 

changes in FDA's workload during ADUF A III. 

Additionally, ADUF A III otfers the following financial recommendations: 

• A new provision for recovering collection shortfalls to ensure adequate funding for the 

animal drug review process. For example, when FDA sets fees for FY 2016, it may 

add to the fee revenue the amount of any shortfall in fees collected in FY 2014. This 

process would follow in subsequent years through the final year adjustment. 

• A modified fee revenue distribution to increase revenue stream stability, reduce 

application fee costs, and minimize the potential for collection shortfalls. The 

proposed distribution will shift from 25 percent for each fee type in ADUF A II to 20 

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percent for application fees, 27 percent for product fees, 27 percent for sponsor fees, 

and 26 percent for establishment fees. 

FDA's recommendation to Congress, after consultation with the regulated industry, is that the 

total fee revenue estimate for FY 2014 will be $23,600,000, which includes one-time 

Information Technology (IT) funding in the amount of $2,000,000. The proposed statutory 

language specifies annual revenue of$21,600,000 for each ofFY 2015 through FY 2018; 

however, this amount is subject to a number of possible adjustments, including for inflation, 

workload, and collection shortfall. 

AGDUFABACKGROUND 

AGDUFA I authorized FDA's first-ever generic animal drug user fee program. AGDUFA I 

provided a significant funding increase that enabled FDA to increase the number of staff 

dedicated to the new generic animal drug application review process by approximately 

45 percent. Furthermore, the authorization of AGDUF A I enabled FDA's continued 

assurance that generic animal drug products are safe and effective and provided consumers 

with greater access to lower-cost therapeutic drugs. 

Under AGDUF A I, FDA agreed to meet performance goals for certain submissions over five 

years from FY 2009 through FY 2013. The purpose of establishing these performance goals 

was to expedite the review of abbreviated new animal drug applications (ANADA) and 

reactivations, supplemental ANADAs, and generic investigational new animal drug (JINAD) 

submissions without compromising the quality of the Agency's review. 

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AGDUFA ACHIEVEMENTS 

AGDUF A I established increasingly stringent review performance goals. In the four years of 

AGDUFA I review performance evaluated to date (FY 2009 to FY 2012), FDA has exceeded 

every performance goal every year with one minor exception. During the program's first 

year, the Agency missed the performance goal by one day for one submission of an 

investigational generic new animal drug. Most importantly, the additional resources provided 

under AGDUF A I enabled FDA to completely eliminate a backlog of 680 submissions in 22 

months. In addition, the Agency has been able to dramatically reduce review times from 700 

days to 270 days. The timely approval of generic new animal drugs continues to be a critical 

component of animal health because it provides quicker access to additional sources of animal 

drugs at lower cost for ranchers, farmers, and pet owners. 

PROPOSAL FOR AGDUFA II 

FDA's goals for the legislative proposal to reauthorize AGDUF A I are to sustain and enhance 

the core program's operation and performance while providing predictable review times and 

resources sufficient to keep pace with actual costs. The Agency is proposing to maintain the 

AGDUFA I goals regarding work queue procedures, timely meetings with industry, review of 

administrative ANADAs, review of protocols without substantial data, and amendments of 

similar applications and submissions. 

FDA and industry agreed to shorter review times for certain reactivations and resubmissions. 

The Agency also agreed to increased communication and transparency with industry through 

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timely meetings and question-based-review (QbR) for bioequivalence submissions, which are 

most often used when a sponsor proposes manufacturing a generic version of an approved offpatent product. The QbR incorporates the most important scientific and regulatory review 

questions that focus on critical pharmaceutical attributes essential for ensuring generic drug 

product quality. In addition, FDA further agreed to implement a process for timely foreign 

inspections as provided in ADUF A II. 

Similar to AGDUF A I, our recommendations for financial enhancements for AGDUF A II 

include a fixed inflation adjuster of four percent each year to achieve the proposed revenue 

levels. We also recommend modifying the base years for calculating the workload adjuster to 

ensure that it adequately captures changes in FDA's workload during AGDUFA II. 

Additionally, the fee revenue distribution has been modified from 30 percent for application 

fees, 35 percent for product fees, and 35 percent for sponsor fees under AGDUFA I to 25 

percent for application fees and 37.5 percent for both product fees and sponsor fees under 

AGDUFA II. The purpose of changing the fee distribution is to increase the stability of the 

revenue stream and reduce application fee costs. 

The total five-year revenue for AGDUF A I was $27, I 00,000. The proposed total five-year 

revenue for AGDUF A II will be $38,100,000, which also includes one-time IT funding in the 

amount of $850,000 for FY 2014 for a first year planned total of $7,328,000. 

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CONCLUSION 

FDA's ADUFA and AGDUF A legislative proposals represent considerable input from and 

agreement of stakeholders, the public, and the Agency. ADUFA and AGDUFA are widely 

regarded as extremely successful programs. The recommendations we have submitted for 

reauthorization of these programs will ensure FDA has a stable workforce to provide the 

predictable and timely review process that drug sponsors need to foster innovation. They also 

will provide for expedited access to new therapies for food-producing animals and companion 

animals, while still ensuring that the drugs are safe and effective. FDA looks forward to 

working with you and your staff to achieve a timely reauthorization of these important human 

and animal health programs. 

Thank you for the opportunity to discuss the ADUF A and AGDUF A programs. I would be 

happy to answer any questions. 

JO 
88 

Mr. PITTS. I will begin the questioning and recognize myself 5 

minutes for that purpose. 

Dr. Dunham, Congress first enacted ADUFA in 2003 and 

AGDUFA in 2008. Would you explain how ADUFA and AGDUFA 

improved FDA regulations of new animal drug, generic animal 

drugs as far as benefit to public health is concerned? And then tell 

us what the new improvements, the improvements in the new proposed ADUFA and AGDUFA agreements, how they would improve 

that. 

Dr. DUNHAM. Yes, sir. These programs have enabled us to adequately have the scientific staff that we need to do our reviews and 

to afford us the opportunity to bring innovative products to our review process, thereby enhancing and protecting both the health of 

the animals and from that, very specifically looking at food-producing animals, to ensuring their health is sustained, and therefore 

any product that you are going to consume should be safe. And the 

extensive review we have to assure that is something that we have 

benefited from with this program. 

And continuing along that line, that also applies then to the 

AGDUFA, or generic animal drugs, where, again, the safety, effectiveness and availability of these products which are needed because of the diversity of the species that we have, these programs 

have both been successful. 

And the public health side is both sides, companion animal medicine to ensure they are safe and effective and keeping animals 

healthy, because, as you know, even with zoonotic medicine, there 

is an opportunity for problems there. So this is one thing we value 

very much when we cross over the lines of public health in everything we do for our review process. 

The changes that we will be looking at are to further enhance 

our interaction with our sponsors in working with them earlier as 

they come forward with innovative products. The more that we can 

partner with them in regards to reviewing the science behind their 

innovation, we can address issues of concerns and help them work 

through this and provide data that can hopefully bring us to a single review. This will allow the expedition of an approved product 

that is meeting all of our standards for safety and effectiveness, 

and get those drugs to the veterinarians for them to be able to take 

care of all the species. And I think the diversity of the species that 

we deal with is challenging, and for that reason these programs 

have helped us tremendously. 

Mr. PITTS. Thank you. 

Why are the ADUFA and AGDUFA agreements so important to 

livestock, and poultry producers, and veterinarians, and pet owners 

and consumers? And what are the consequences of the not reauthorizing the animal drug user fee programs? 

Dr. DUNHAM. Again, with the success that we have had and the 

capability of bringing forth more safe and effective products to address the plethora of diseases that we have because we have so 

many species that we need to look at, this program has led to that 

success. And there are still many, many more diseases that we 

need to address with our sponsors. 

The program, if we were not to continue this, would, in fact, set 

us back. The way in which we have been able to have expedited 

89 

reviews, i.e., work with our companies to address and review the 

science, if we don’t have the staff to complete that, we are going 

to be turning back and having slower reviews, and that is going to, 

I think, lead to harm because we are not going to have the needed 

products that we want out there to address the concerns of the 

health of the animals that we take care of every day. 

And I do believe that with the programs sustaining us, there is 

a lot of new science coming forward, and the challenges for having 

these review processes will bring the best of the best together and, 

I think, open more venues that we see information that we gather 

on the animal side many times transmits over for information on 

the human side. 

And so I think together we can be a force to reckon with, because 

this is what we need in this day and age. And more importantly, 

I think it is something that we understand these drugs that we develop, although we need many of them, there is innovative science 

coming onboard, and we have to be very judicious in how we use 

the products, as you mentioned earlier in the testimony coming 

forth with the Members. And I think the more that we are aware 

of the complexity of the challenging reviews that we have, the more 

we can work together to ensure public health. 

Mr. PITTS. All right. How do ADUFA and AGDUFA take small 

businesses into account? What accommodations do these programs 

make for them? And then finally I want to ask how does ADUFA 

foster innovation in drug development? 

Dr. DUNHAM. With the opportunity to give waivers for sponsors 

where they are small businesses, we can work with them. And 

many times on the first round through, we will work very closely 

with them to help minimize the cost factor the first time around. 

We are also able to give waivers, as we have always done, for 

anything from minor species. And at the same time that we do this, 

we work very closely with the sponsors to bring them in earlier, as 

I said, to be able to address what they propose to do and understand the procedures they have to go through in order to get there. 

For generic drugs, where they will copy your pioneer, we have an 

opportunity there on the fee system that we can address the small 

businesses so that if it is the first time in and they haven’t had any 

approvals, it is a much lower fee, and once they get above six applications approved, it will be an increase in the fee on that one, and 

when they have had more than that. So we give a break on the finances in order to help them, and all of our sponsors have benefited from that. 

When the sponsors are able to have recovery of not only the efficacy and the speed with which drugs are approved, then when you 

get it to market, the benefit comes back always for research. When 

we can do that, they are able to break ground with innovation. And 

what we do now is we try to meet with them very, very early on, 

even before they are coming with the application, so that we can 

understand where they are going to be going. And with these opportunities we can then fine-tune issues or be able to flag something that is going to be very challenging, and work with them to 

review sooner, and be able then to hopefully have all of these various technical sections that they have to meet be met thoroughly 

and effectively, and hopefully with one cycle review. 

90 

So having our staff be able to engage in interaction with them 

has been a real success rate. I think the sponsors have also improved, because the more that they can understand what it takes 

to have a really good application coming in the front door, the 

quicker we are going to have a single review, and that is the goal, 

and that is the time saving across the board. 

Mr. PITTS. The chair thanks the gentlelady, and my time is expired. I now recognize the ranking member of the subcommittee 

Mr. Pallone, 5 minutes for questions. 

Mr. PALLONE. Thank you, Mr. Chairman, and thank you, Dr. 

Dunham, for being here today. 

I know you are not likely to answer the question, but I have to 

ask you really just to alert the FDA to an issue that I am concerned about, and that is implementation of an e-labeling or a 

paperless labeling system for drug products. And I would like to 

quickly use this opportunity to go on record with a question and 

look forward to hearing back from the FDA in a timely manner. 

Three successive FDA unified agendas starting in the spring of 

2009 have contained notice of a proposed rule signaling to me that 

electronic distribution of required drug product prescribing information is an FDA priority. E-labeling would ensure that most upto-date prescription drug product, safety and efficacy information is 

available to healthcare providers, something I think we all agree 

is critical. In addition, it would also provide significant gains to patients, manufacturers and dispensers. In today’s world current 

technology makes e-labeling a viable alternative that has tremendous value and could hopefully also lower costs. 

So my two questions are given the need for e-labeling, is there 

a date that the agency can commit in regards to completing the 

rulemaking process in implementing e-labeling? And second, is 

there any update on your process moving forward that you can 

share? And I don’t expect you to answer this, but if you want to; 

if not, through the chairman, you know, have the FDA get back to 

us. 

Dr. DUNHAM. I would be delighted to pass that question over to 

the key members in the agency that can address that and have 

them get back to you as soon as possible. 

Mr. PALLONE. Thank you. 

Thank you, Mr. Chairman. 

Now, getting back to the Animal Drug User Fee legislation, Dr. 

Dunham, I want to thank you for your testimony about these important programs. It is clear they have been every bit the success 

that the other user fee programs at FDA have been. They have allowed the agency to move efficiently and effectively to review animal drug applications, and have provided industry with predictability and, of course, speedier reviews. And I am glad to be a cosponsor of the legislation. We will work to see that it moves 

through this committee in a timely way. 

Another topic at today’s hearing which has come up is antibiotic 

resistance and its relationship to the use of these important lifesaving drugs in food-producing animals. As this committee well 

knows, antibiotic resistance is a grave public health threat. I recognize that there is a growing concern among stakeholders and some 

members of the subcommittee about the use of antibiotics in food 

91 

animals. Specifically they say that there is a lack of data on how 

antibiotics are used and in what quantities. But in the 2008 

ADUFA reauthorization legislation, we did include some provisions 

to address this knowledge gap. 

So my first question is can you tell us about what those provisions did? Then what kind of information did you get as a result? 

And do you think it has been successful overall? In 2 minutes. 

Dr. DUNHAM. Actually, in fact, it was very successful. I think section 105 allowed us to be able to report out what the sponsors did 

with regards to sales of their drugs and distribution. And when we 

did this, it was really good because we had a lot of comments coming back, and, in fact, the comments have said, can we do more, 

and can we make this even more useful? 

And I think always we would appreciate the opportunity in ways 

to work with everybody to get the best data. And what we have 

done is we have now also put out an advanced notice of proposed 

rulemaking just to do that, to gather information from many stakeholders as to additional ideas for how to improve, what this data 

would look like. There are areas that we would like to refine, and 

we hope with the 2012 report we are going to see the format 

change. 

And further, based upon receiving some additional input, one of 

the areas that you know is important is how do we gather information on use data, and this is something that extends way beyond. 

And we do want to be able to work with our other agencies, such 

as USDA and CDC, and academia to figure out some ways to do 

this. And we have also been looking at different programs internationally. People are embracing how to do this. 

So I think this is a very good way for us to reach out and improve this, and we look forward to reviewing the comments and 

coming back with some proposals. But I think this is something 

that we all want to work together on. 

Mr. PALLONE. Well, you still have 30, 40 seconds here. What kind 

of information did you actually get, though? 

Dr. DUNHAM. We are talking fast. 

We were able to put out exactly what—the actual indication for 

the groups of animals. We do it in aggregate, and they will be able 

to say what the dosage is, what the form of administration is, their 

sales distribution. 

The issue there has been could we have more, can we refine this, 

and I think that there are areas that we can, and this is what we 

do with working with our stakeholders to be able to fine-tune this 

so we can have a little bit more information. 

I think what is really critical is we are also very nicely at the 

same time doing two other things. We have a proposal out there 

right now, which is Guidance 209, which we did finalize to say we 

do want to phase out growth promotion and feed efficiency use of 

medically important antibiotics and bring back in oversight by veterinarians. And Guidance 213 is how we work with our pharmaceutical companies to make the label changes appropriate to do just 

that and to change that authorization on the labeling as well. And 

the veterinary feed directive is one of the key tools that will come 

back in with the hands of a veterinarian to do all of that. That is 

happening simultaneously. 

92 

What would be really good now is as we fine-tune all of this, 

what does that look like when you really do see these strengths occurring and you are getting feedback from what the distributions 

are, and how we can further enhance this reporting schedule. And 

I do think everything is coming together in a way that I really appreciate with collaboration in addressing the very important issue, 

because, as you said earlier, it is a very important issue internationally. Everybody is involved. Judicious use is critical no matter what the antimicrobial. And I think together now you are finding everybody rallying, and I think in the spirit of collaboration, 

this is the best I could ever have. I am very grateful to work with 

so many fabulous folks coming up with new ways of addressing this 

very important issue. 

Mr. PALLONE. All right. Thank you. Thanks very much. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentleman from Illinois Mr. Shimkus, 5 minutes for questions. 

Mr. SHIMKUS. Thank you, Mr. Chairman. I think I am going to 

be following up on my friend Mr. Pallone’s question. But before I 

do that, Dr. Dunham, I see you got your Ph.D. In cardiovascular 

physiology from Boston University; is that correct? 

Dr. DUNHAM. Yes, sir. 

Mr. SHIMKUS. Is that animal cardiovascular physiology, or is it 

one and the same or—— 

Dr. DUNHAM. Believe it or not, it was actually in a medical program that I was doing with my basic science Ph.D. So it was done 

at Boston University and Harvard Medical School. So we were 

dealing with patients, and we had then some opportunity for liveanimal medicine. 

Mr. SHIMKUS. Obviously with the University of Illinois close to 

my district and knowing folks who have gone into veterinarian 

medicine, it is a pretty stringent, obviously, path to get there and 

sometimes more difficult, some would say—— 

Dr. DUNHAM. Yes, it is. 

Mr. SHIMKUS [continuing]. Than some other aspects. So I just noticed that on your bio and wanted to ask about that. 

And you have been with the FDA for a long time. 

Dr. DUNHAM. Yes, since 2002. 

Mr. SHIMKUS. And the other point is that in this day and age, 

when we question role of government, I think the FDA and really 

the history with this program, it really does talk about the benefits 

of some government activity involved in protecting the safety and 

advocacy of our food supply for our public. So it is—I mean, even 

conservative Republicans have to talk to some of our friends in the 

district and say, yes, there is a role for government, and this is one, 

and this has been helpful, and why. 

But can you walk us through what you have done and the FDA 

actions have been over the past few years when it comes to this 

whole debate on the animal use—antibiotic use in animals? 

Dr. DUNHAM. What we have done is we have always had a very 

detailed review requirement on safety and effectiveness for drugs 

being used in food animals, and we have developed one important 

document, Guidance 152, which really did take a look at the very 

important drugs and to put those into a category of those that are 

very critical and most important. And with that the majority of all 

93 

our antimicrobials are, in fact, under prescription. It is the very old 

drugs that you know have these particular labels on them that 

were not as specific as we would like them. 

Anymore now it is really important that we understand what the 

pathogen is, what the disease is that it caused, how do you have 

the correct label, and then working with the veterinarian and the 

producers together, because everybody is engaged in this to make 

sure we have a very healthy animal and, from that, a safe food 

product. Working together they are able then to assimilate exactly 

what would be the requirement for a drug to be used and to follow 

through. 

And now anymore we are able to fine-tune, working with laboratories and also our national antimicrobial resistance monitoring 

system, to really be able to understand what these pathogens are 

doing and where is the resistance occurring. 

Number one, I don’t want the drug to develop resistance in the 

animal, and I certainly don’t want to have a problem with resistance in people, and that is why everybody has a role to play in judicious use of these very important drugs. And these programs now 

bring us together so that we can track and follow through to see 

what is happening. And the more that we have the veterinarian 

back overseeing and working closely, this will be another way of 

enhancing that judicious use, which is really important. 

And in combination, that data comes back that we are looking at 

for our review process so that we can be able to see what is happening with resistance and follow that across the board. And I 

think this way, if there are three or four drugs, it will be a veterinarian to work at that program, understand that particular production site, and be able to select the best antimicrobial, and be able 

to follow that. 

Mr. SHIMKUS. My time is running short. And you were talking 

about older drugs and stuff. What authority currently does the 

FDA have to restrict the use of any antibiotic that my have adverse 

impact on human health? 

Dr. DUNHAM. I am sorry, could you repeat that one more time? 

Mr. SHIMKUS. What authority does FDA have today on—you 

know, if there was an old antibiotic that they might suggest might 

have an adverse impact on human health, what can FDA do today? 

Dr. DUNHAM. Right now, as I mentioned, we have taken a very 

active approach to be able to work a collaborative procedure to be 

able to phase those out. We have identified them. We have said 

these older drugs that are medically important will be phased out. 

We have 213, which is the guidance we would like to see finalized 

and approved this year. Within the first 3 months the sponsors will 

let us know their intention, and we have given them 3 years to 

make those changes, and this allows us to then go to a mandatory 

process if they don’t. 

Mr. SHIMKUS. So this all debate occurred in your discussions 

with the, obviously, stakeholders in the industry and yourself. 

Dr. DUNHAM. Yes. This is one thing that I am very proud of to 

think that we have reached out and said, you know, we have a 

problem, we all know this. How can we all work together through 

this? And I think when everybody rolls up their sleeves and comes 

to the table and addresses this issue, you bring the best of the best 

94 

out of everybody and many solutions. And not one size fits all, so 

how do we do this? And doing it together I think is a real success. 

So I am looking forward to that. 

Mr. SHIMKUS. Thank you very much. 

I yield back, Chairman. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentlelady from California Mrs. Capps for 5 minutes for questions. 

Mrs. CAPPS. Thank you, Mr. Chairman, for holding this hearing. 

I know my colleagues have heard me talk a great deal about the 

beauty of an innovation that takes place in my district. One of our 

biggest agricultural sectors is cattle production, so having a working Center for Veterinary Medicine at the FDA is very important 

to the central coast of California as well. 

I want to thank the agency and industry partners for working together to come up with their agreement. I am pleased that we are 

here working on this topic today, and thank you, Dr. Dunham, for 

your testimony. 

It seems clear that over the years FDA has recognized that the 

use of antibiotics in food-producing animals can lead to the development of drug-resistant infections in humans. In 1999, FDA released a framework to evaluate the potential impact antibiotic use 

in food-producing animals could have on the development of antibiotic resistance in humans. 2005, FDA withdrew the approval of 

one such antibiotic, fluoroquinolone, for use in poultry because a 

significant increase in resistance to that drug was observed in humans after it became widely used in chickens. 

More recently FDA has announced that it is unwise and irresponsible to use important human antibiotics for growth promotion 

in animals, and the agency has taken a number of steps to encourage the industry to voluntarily stop such uses. 

Dr. Dunham, can you and will you now tell us a bit more about 

what went into the withdrawal of fluoroquinolone and the human 

health concerns that led FDA to take this extraordinary step? 

Dr. DUNHAM. Thank you, Representative Capps—we had an opportunity to, again, bring the best science forward and to follow 

this along. And with the data that we had at that time, one of the 

problems that we have seen is Campylobacter is a problem within 

poultry. And when we had an opportunity to watch what was happening, when exposed then to the drug, at that time the data was 

being collected so that we could see there really was not only the 

hazard, but then once there was further exposure, then we had a 

problem that we were able to identify. And upon doing so and collecting the best science and review, then we were able to take action. 

And I think once we know the risk, the hazard, the exposure, 

that is the time when you have all the science that can be behind 

you when you make a decision like that. And then we went forth 

with that proposal at that time, and a few years later it was taken 

off the market. 

Mrs. CAPPS. I appreciate your response and this example, which 

I was hoping that would be addressed in this way, because it really 

highlights a troubling glimpse, I believe, into the dangers to human 

health from the overuse of important antibiotics on farms. And I 

95 

am glad that we can see as a committee that you are in your Department attempting to build cooperation from industry in eliminating unnecessary uses of these drugs through a voluntary approach. But I do hope, and I guess this is the cautionary note, that 

if the voluntary approach fails, that FDA will either take a leadership role with regulatory action, or come back to us to let us know 

that you need new authority. 

I believe we really—this is scratching the surface here with this 

one example. Antibiotic overuse does pose a harmful public health 

threat, and we need our preeminent public health regulatory agency to do all it can to protect American people and preserve the effective of these lifesaving drugs by overuse, and they become less 

effective when they are really needed for something else that is serious. 

Last Congress we had numerous debates right here in this room 

about the shortages in the antibiotic pipeline and about the numerous potential superbugs that are resistant to our current antibiotic 

arsenal. These are human causes like overprescription and improper use. There are—one of things contributing to this is overprescription and improper use that contribute to the resistance for 

sure. But as FDA’s actions now have shown, animal uses also contribute, and I wanted to get that on the record so that we could 

highlight the importance. These issues are related, and I urge this 

committee and my colleagues to work together on this aspect of 

this issue so that we can address the full causes of antibiotic resistance. I appreciate your testimony and your being here today. 

I yield back the balance of my time. 

Mr. PITTS. The chair thanks the gentlelady and now recognizes 

the gentleman from Virginia Mr. Griffith, 5 minutes for questions. 

Mr. GRIFFITH. Thank you so much for being here today; do appreciate it very, very much. 

You know, we look at these issues, and I am very concerned 

about the ag issues in my district, and it is one of largest industries in my district. I have been looking for ways to promote it and 

ways to expand it, and, of course, these issues that you bring up 

today are very important. 

According to the National Cattlemen’s Beef Association, there are 

approximately 7,600 beef farmers and 220,000 head of cattle in the 

Ninth District, and that is not counting our lambs and our goats 

and everything else that we have. For this reason development and 

approval of new animal drugs and generic drugs, including antibiotics, are very important to the farmers that I represent. 

I do appreciate your being here and the positive relationship that 

I am told exists between your office and the stakeholders in the ag 

and pharmaceutical industry. So I do appreciate that. 

I am concerned about large-animal vets and the shortage we 

have of those. I understand that there is a big concern about that 

shortage, and I am just wondering if the FDA is taking those concerns into consideration when proposing new guidance documents. 

Dr. DUNHAM. Thank you very much. And, yes, we are. We have 

been meeting with the American Veterinary Medical Association 

because this issue of do we have sufficient food-animal veterinarians available has been an issue for a number of years. 

96 

And the other thing that is happening while we address those 

issues is to understand the plethora of veterinarians and where 

they are located versus where they are not, and how things have 

changed with regard to the practice of veterinary medicine as we 

have seen even with human medicine, and the technologies are enabling a tremendous amount of change that we want to embrace. 

Just for example, we have the capability of smartphones. We 

have the capability of labs talking to each other much better and 

correlating and very quickly turning things around. So you think 

about all of that, and you say, well, how can I do this even more 

effectively? We need to hear from the producers and the veterinarians as to how we can coordinate this. The opportunity for veterinary technicians has been looked at. The universities are all embracing where advancements in medicine have taken us and how 

then are we using those in practice. 

The coordination with some of our producers are state-of-the-art 

with how, as you know, they are set up, their track record, their 

records of medical references, their access to laboratories, and, 

again, a veterinarian to be there, which is so important, to oversee 

and work through this and be able to prescribe and know what is 

happening with those herds to ensure their health is there, again, 

to make sure we are protecting public health and any food item. 

And I think as we talk through them, there is a variety of different ways of addressing concerns as we work through these, 

where I said, again, not one-size-fits-all and we learn from each 

other, and certain things that work in one State can work in another State. 

The opportunity, again, for communication is going to be critical 

as we establish the veterinary-patient relationship in a way that 

embraces today’s technology, where we are located and how we 

interact. And I have been very, very pleased. We had a committee 

that was brought together through the American Veterinary Medical Association for just that purpose, how do we work through 

these challenging issues right now. And, in fact, there are a number of students that I am very pleased are continuing to seek their 

careers in the food-animal production side of veterinary medicine. 

Mr. GRIFFITH. Well, I have got two questions arising out of your 

answer. One, do you think that we should be working to see that 

we get either larger enrollment in our existing schools, or should 

we be looking to maybe expand and have some new veterinary 

medicine schools open up in the country? 

Dr. DUNHAM. Well, actually there are a few more schools that I 

think will be opening up. I think the most important thing is for 

us, when we are talking to the next generation, is to encourage 

them, I think, to a stellar occupation in veterinary medicine. I can’t 

be prouder to be a veterinarian because of the plethora of issues 

that we get to be challenged with. It is fantastic, and it is so rewarding to encourage them and let them know there are careers 

in the field. That is one thing I would love to see us do more of. 

The schools themselves are actually top notch. And you mentioned a minute ago that it is oftentimes more challenging, Representative Shimkus, to get into veterinary medicine. That is true. 

But I think the rewards that you get afterwards in the public 

97 

health mission that we accomplish every day is outstanding. So 

that would be part and parcel of what I would encourage. 

Mr. GRIFFITH. And then the other question I would have, we had 

some hearings about medical devices before we left, and there were 

some interesting cheap fixes that we saw, and there were other 

issues involved that wouldn’t affect the veterinary side. But I am 

just wondering if FDA is prepared to move a lot of those things forward fairly quickly, because we learned about a device that was 

being used for children in the African Continent, but it was an $8 

hack onto a smartphone. And it would seem to me, you know, as 

the FDA prepared—I know you can’t answer for people—but on the 

animal side, are we prepared to get that stuff out into the field as 

fast a possible when it is something as simple as an $8 hack on 

a smartphone? 

Dr. DUNHAM. As long as we can keep things and make sure it 

doesn’t impinge on safety and effectiveness, we are going to work 

through a number of these opportunities to be able to further enhance how we can share information that is so rapid and moving 

so quickly, and also tracking. And I think with that there is that 

capability of, you can pull up an X-ray or lab report. 

You could have our veterinarians, which are first responders, 

getting back to us very, very quickly right now, and I think that 

alone says so much when you realize how quickly everything moves 

in this day and age. Internationally we travel, animals travel, microbes travel. It is incredible. Food is already across countries before you can blink your eye. The more that we need to embrace 

technology for all the benefits, it is also quintessential in protecting 

animal health and public health to be able to enhance those communications. 

Mr. GRIFFITH. Thank you so much, and I yield back, Mr. Chairman. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentlelady from Virgin Islands Dr. Christensen for 5 minutes 

for questions. 

Mrs. CHRISTENSEN. Thank you, Mr. Chairman, and thank you for 

your answers as well and your testimony. 

I also want to follow up on the resistance issue, and I think just 

to step back for a moment and make sure that we all understand 

what we are talking about. And for the record, could you give us 

a brief overview of how antibiotic resistance developed, and why it 

is a particular problem with continual long-term administration of 

antibiotics in feed or water as is done for growth-promotion purposes? 

Dr. DUNHAM. I think the question of antimicrobial resistance is 

challenging. It is incredibly complex, and I don’t have the answer. 

But I do know that there are incredible minds internationally 

working on this, as we all need to, every day, because it touches 

all of us, not just humans and not just animals; everything, plants 

as well. So the more that we are able to understand the complexity 

of this, we have the opportunity to intervene. 

No matter what, judicious use of any antimicrobial, anywhere, 

from a dentist, physician or veterinarian, is quintessential. That 

being said, then that is why it is so important that we have the 

veterinarians overseeing and using these drugs with their medical 

98 

training, and working closely with the producers who absolutely 

then know their animals and how we can coordinate this and track 

it. 

I think that part is happening more and more, and the recognition that if you use an antimicrobial, you are putting pressure back 

on that pathogen. You want to make sure you have eliminated that 

pathogen. So knowing the right antimicrobial to choose based upon 

what the pathogen is and the disease that it has caused, and to follow that through or to work up your lab to be able to decide that, 

that is the kind of stuff that we all have to embrace, and that is 

what we are seeing. 

So one thing we have chosen, as I mentioned, was to recognize 

that I think growth promotion and feed efficiency were very, very 

older claims on antimicrobials way back, and what was missing 

was exactly the pathogen, and the disease and the dosage. Now we 

want to come fast forward, and all of these very important drugs 

need to have that, and they need to be under veterinary oversight. 

So where they would have been in the past, we are now looking to 

do that; phase out, labels will be changed, identification is on the 

label. So now when a physician or a veterinarian is looking at this 

label, it will identify that, and then they can do the proper workup. 

That brings us back again to developing judicious use across the 

board. 

Mrs. CHRISTENSEN. As a physician, you know, we are always 

pressured to give antibiotics for viruses, for flus and so forth. 

Sometimes that is quite unpopular because you just don’t do that 

unless you have a pathogen. So it is important, as you said, in 

human health as well as in animal. 

But when we held a hearing on antibiotic use on animals back 

in 2010, one thing we heard from some animal producers was that 

growth promotion was actually a manifestation of disease prevention; and that is, the reason why antibiotics could make animals 

grow faster and use feed more efficiently was that the low chronic 

doses of antibiotics actually were preventing disease. The question 

that raises, of course, is whether when the industry says it phasing 

out growth-promotion uses of medically important antibiotics, 

maybe it simply intends to change the label, but not its practices. 

So could you help address this question for us: How does FDA 

define disease ‘‘prevention’’? And is it possible for industry to essentially switch a growth-promotion claim to a disease-prevention 

claim with just some data showing that the same dose of a drug 

that promotes growth will also prevent a disease? 

Dr. DUNHAM. That is why with Guidance 213, which we certainly 

hope will be finalized this year, it will have us work very closely 

with the pharmaceutical company, because now they really do have 

to come back. And if there is going to be a prevention claim, it has 

to be able to identify everything we just talked about very clearly, 

because that is what was missing before. 

Mrs. CHRISTENSEN. So you don’t have a definition for ‘‘disease 

prevention’’ in this instance? 

Dr. DUNHAM. You will see that in 213. But basically if you want 

to control something, that means you already have a problem. You 

can see within a herd there is a group of animals that have a probVerDate Nov 24 2008 15:12 Jan 17, 2014 Jkt 037690 PO 00000 Frm 00104 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-25 CHRIS
99 

lem, and you want to see to be able to prevent and control that 

from further expanding. 

If you want to prevent, you would need to have, again, an awareness of the history of the animal, the herd, and whether or not as 

a veterinarian everything you have seen indicates that you can be 

expecting something to happen. But you would still have to now 

very much understand what that pathogen is to be able to make 

that call. And only the veterinarian, in pulling everything together 

in their medical history, would make that decision, and it would 

have to be then, as far as the drug sponsor coming in and have a 

label, that if they are going to put that claim on, what are they preventing, and what is the surrounding circumstances that a veterinarian would need to make it happen. 

So you would have treatment, control and prevention in each one 

to be fine-tuned and explained, and now those labels would have 

to meet this new criteria before they could have that on them. 

Mrs. CHRISTENSEN. Thank you. 

Thank you, Mr. Chairman. 

Mr. PITTS. The chair thanks the gentlelady. And now recognize 

the gentlelady from North Carolina, Ms. Ellmers, for 5 minutes for 

questions. 

Mrs. ELLMERS. Thank you, Mr. Chairman. 

And thank you, Dr. Dunham. And a moment ago you were speaking with my colleague, Mr. Griffith, about the excellent veterinarian schools in the country. And being a member representing 

District 2, North Carolina, I have to speak up for the NC State 

School of Veterinary Medicine; excellent school. And I will just 

have to add, as I have told everyone that I have come in contact 

with over the last 2 weeks, that my son has been accepted to NC 

State in the agriculture business school. 

Dr. DUNHAM. Fantastic. 

Mrs. ELLMERS. So I am very excited about that. 

I am concerned. You know, in North Carolina, agriculture is the 

number one industry, and, you know, ag and our farmers, so important. Some of the larger farms, entities, you know, doing great 

and certainly have their issues to deal with. Some of the smaller 

farm entities, obviously any of these, you know, any more regulation or any more burden we put on them just makes it harder for 

them do what they need do. And, you know, I am particularly concerned about those farmers in the administration of any of these, 

you know, any of the jeopardy that we put them in. 

You know, how would you explain to them that they can use the 

FDA? And I will just talk about the veterinary feed directive. How 

can we speak to them and know that this is something that is 

going to be feasible for them, something that is going to be workable, that they will be able to take advantage of, but at the same 

time be able to afford cost-wise? 

Dr. DUNHAM. That is a great question. And I am actually able 

to tell you right now we are very pleased because we have just 

teamed up with the USDA. We are having five very special outreach listening sessions to address and listen from folks that are 

in either very remote locations or their concerns as to what this 

will do and mean for them. So right now we have our first one, 

which actually took place in Bowling Green, Kentucky today. 

100 

Mrs. ELLMERS. Great. 

Dr. DUNHAM. And then we will be doing Olympia, Washington, 

Fort Collins, Colorado, Pierre, South Dakota, and College Station, 

Texas. And it is for that whole purpose, both listening to veterinarians as we have been doing, but also the producers, what are some 

of the hurdles they think they will be facing and how will we help 

them move through this, because it is not one size fits all. And you 

are absolutely correct, a smaller group versus a big producer that 

has everything they need, how do we help them understand those 

issues and how can we work with them. 

The aspect of the veterinarian and how can they establish their 

veterinary patient-client relationship, they can set that up, and 

they have now a lot more latitude of what does that look like. And 

how you and I can set it up would be different to how I would set 

it up with somebody else. That is going to help. And the more that 

we dialogue them, that is going to bring us together to address 

their concerns so that we are not going to be adding further to 

their challenging days, because we need them, be they small or 

large, they are all a part of what we want with agriculture. And 

I am very pleased to know that we have been having some good 

feedback with them. 

And they share their concerns already. We have had a lot of 

meetings with different producers. They have come in or they have 

actually come into D.C. and they have come from different States, 

and we have had a chance to meet with them, explain what this 

all looks like, what will the veterinary feed directive be, and how 

a veterinarian now has the opportunity to fine-tune and be responsive for this and to work with them. And I have been really, really 

impressed with the willingness to say, well, I have this issue, 

maybe we could do this, what about this. That brings out the best, 

and the solutions are going to be terrific coming forward. 

Mrs. ELLMERS. Great. Well, thank you. And, you know, I am glad 

you mentioned coupling with the USDA, because my next question 

has to do with, you know, the veterinary shortages that of course 

across the country we are faced with. And, you know, one of the 

things that we are looking at here in Congress are the possibility 

of, you know, basically veterinarian medicine loan repayment programs. And, you know, from your perspective, I don’t want to put 

you on the spot, you know, but there is a high basically tax that 

is associated with that, as high as 39 percent of repayment. In your 

opinion, coming from the FDA and having to do with our farmers 

and agriculture across this country, to me, I mean, that is pretty 

straightforward. That is a pretty negative effect, especially when 

you are talking about trying to serve underserved areas. What is 

your opinion on that? And I mean, just in the 40 seconds you have 

left, if you can just give me a little idea of what you think. 

Dr. DUNHAM. That is definitely a challenge. I think all of our students, no matter where they are, are facing tremendous, tremendous burdens with the student loans. Any possible way we can assist is going to be welcomed, and they appreciate that. And yet 

when I meet with the students, they are absolutely dedicated and 

thrilled to be doing what they want to do, and yet they are willing 

to take on these loans. So anything we can do to help is what we 

have to do, and to show them that there is still a way to have a 

101 

career that is incredibly rewarding while, as you said, paying off 

these loans. 

So I do welcome that. I know all of the associations are trying 

to do something. We would like very much to even have a student 

loan repayment program ourselves. Haven’t quite got all the money 

for that, but I would love to do that. But anything that we can do 

and encourage would be a real positive, because we need them, it 

is a career that we have to have and sustain. Veterinary medicine 

is so important. I know many times we look at those as just being 

the ones that take care of the animals, but veterinary medicine 

crosses so many areas. 

Mrs. ELLMERS. Absolutely. 

Dr. DUNHAM. And they come with the most incredible dedication. 

And then their experience, maybe they will be members of Congress. It will be fantastic what they can continue to do. 

Mrs. ELLMERS. Great. I truly appreciate your testimony. Thank 

you. 

Dr. DUNHAM. Thank you. 

Mr. PITTS. The chair thanks the gentlelady. I know the gentleman just walked in. We are about to wrap up questions. 

Dr. Gingrey, do you have any questions you would like to ask? 

Dr. GINGREY. Mr. Chairman, I think I will just pass at this time. 

Thanks. 

Mr. PITTS. All right. 

All right, at this time, then, with unanimous consent, we will 

recognize Representative Gardner, 5 minutes for questions. 

Mr. GARDNER. Thank you, Mr. Chairman. And thank you, members of the committee. 

Dr. Dunham, thank you for your testimony today. And just a couple of quick questions for you. Everybody has bragged about their 

vet school, so I will throw in a word for Colorado State University 

and the aforementioned Fort Collins, Colorado, where you will be 

having a clinic here, at least a forum, very soon. So thank you for 

your participation in that. 

In your testimony you described the significant backlog on generic applications prior to the authorization of AGDUFA. What 

caused that backlog in the first place? And if you don’t mind maybe 

talking a little bit about the causes. Was it simply a matter of resources? Go into that a little bit. 

Dr. DUNHAM. It was actually resources and just not having the 

resources to have the dedicated people we need to do that review. 

And I can’t echo enough how appreciative we are of this program, 

because once you get a chance to fill the resources and have staff 

that can do the review, it is incredible what you can accomplish. 

And to have that sustained reliability, then, on not only keeping 

our FTEs, but you are able to then give back to the companies to 

know exactly what these performances are. And together we can 

enhance and get those drugs reviewed. And so that is why this program and its reauthorization is critical, because we have established so much, and I would hate to see us go back. And the success story exemplifies that. 

Mr. GARDNER. I think in your testimony, I believe you were talking about, was it was AGDUFA or ADUFA? I think you talked 

about hitting every single performance goal except for the one—— 

102 

Dr. DUNHAM. That was on AGDUFA. 

Mr. GARDNER [continuing]. By one day. And that was AGDUFA, 

correct, as a result of this? 

Dr. DUNHAM. Yes. 

Mr. GARDNER. And in your discussions with farmers and ranchers, I know you spoke with my colleague a little bit about this, can 

you describe the importance of having generic drugs on the market? 

Dr. DUNHAM. I think it is really important. As we all know, we 

always value what the cost factors are. And just like on the human 

side, it is an opportunity to have a safe and effective drug that 

would be able to give you some cost savings. And I think, as you 

said earlier, with the plethora of animals and species we have, you 

can see how much more diversity we are going to have to deal with 

all of that. 

So the more that we can have generic drugs come through and 

have their approval, it is going be helping everybody. We need so 

many drugs approved for so many different diseases in so many 

species, it is constantly challenging us. So this is another plus, and 

I have been very impressed with what they have done. 

Mr. GARDNER. About 2 months ago, Jennifer Johansson, who is 

the vice chair of the Generic Animal Drug Alliance, testified before 

the Senate HELP Committee stating that the number of generic 

new animal drug applications decreased after the implementation 

of AGDUFA. Are you aware of a reason for this? Do you feel at the 

present time that the submissions are adequate to provide available generics to producers? 

Dr. DUNHAM. I think we are seeing that. I think at the time we 

were also going through some economic turmoil and I think there 

was a little bit of hesitancy, we even saw that, as to how many applications were actually coming in, and that is something that goes 

along with what happens in the market. But that seems to have 

leveled out right now, and I would have to say that I think we are 

going to continue to see more coming forward. 

Mr. GARDNER. You mentioned some of the feedback, the forum, 

the information you are getting from stakeholders. We have talked 

about what you are getting from veterinarians, what you are talking about getting from people in the livestock industry. Could you 

describe the stakeholder process with other people who may be outside of the industry itself but who are interested in the pharmaceutical issues as it pertains to the animal side? 

Dr. DUNHAM. Yes. And we have a number of stakeholders, many 

of them are here actually today in the audience. We have a number 

of other activist groups, i.e., that are helping us across the board 

with anything on medicine, consumers, academics, association 

groups that you will see here trying again to see how can we work 

together to address whatever these challenging issues are. Working 

with other agencies as well brings us forward. The public at large. 

We often have calls, letters from the public with their issues and 

their concerns all the way from whatever it is with companion animal medicine to the issues du jour of how we can be more judicious 

in the use and protection of antimicrobials. I know we don’t do the 

biologics, that is done with USDA, but together those will help adVerDate Nov 24 2008 15:12 Jan 17, 2014 Jkt 037690 PO 00000 Frm 00108 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-25 CHRIS
103 

dress the health concerns that we face and the venues of how we 

can all come together. 

And what that also does is it brings some of the best scientists 

and the issues du jour and how fast science is advancing. And so 

there have been opportunities to further collaborate with groups. 

They have come in and suggested different things that we can do 

with them. The sharing of information has been absolutely fabulous on that end. 

Mr. GARDNER. Thank you, Dr. Dunham. I yield back my time. 

Mr. PITTS. The chair thanks the gentleman. That concludes our 

first panel. 

Thank you very much, Dr. Dunham, for coming, for all the good 

information and testimony you presented. The members may have 

additional questions. They will forward those to you if they do. 

We will now call the second panel to the witness stand and I will 

introduce them as they come. Dr. Richard Carnevale, Vice President of Regulatory, Scientific and International Affairs, Animal 

Health Institute. Secondly, we have Dr. Mike Apley, Professor and 

Section Head of Production Medicine and Clinical Pharmacology, 

College of Veterinary Medicine, Kansas State University. Thirdly, 

Dr. Lance Price, Professor in the Department of Occupational and 

Environmental Health, George Washington University. And that 

concludes the second panel. 

Thank you all for coming. You will each have 5 minutes to summarize your testimony. Your written testimony will be placed in 

the record. 

Dr. Carnevale, we will start with you. You are recognized for 5 

minutes. 

STATEMENTS OF DR. RICHARD A. CARNEVALE, VICE PRESIDENT, REGULATORY, SCIENTIFIC AND INTERNATIONAL AFFAIRS, ANIMAL HEALTH INSTITUTE; DR. MIKE APLEY, PROFESSOR AND SECTION HEAD, PRODUCTION MEDICINE AND 

CLINICAL PHARMACOLOGY, COLLEGE OF VETERINARY MEDICINE, KANSAS STATE UNIVERSITY; AND DR. LANCE B. 

PRICE, PROFESSOR, DEPARTMENT OF OCCUPATIONAL AND 

ENVIRONMENTAL HEALTH, GEORGE WASHINGTON UNIVERSITY 

STATEMENT OF RICHARD A. CARNEVALE 

Dr. CARNEVALE. Thank you, Mr. Chairman and members of the 

subcommittee. Thank you very much for holding this hearing on 

this important piece of legislation, as you have aptly described 

today, and for the opportunity to speak to you today about an important human and animal health benefit that results from using 

medicines to keep animals healthy. 

I am Dr. Richard Carnevale. I am a veterinarian by training 

with a degree from the University of Pennsylvania School of Veterinary Medicine, and I am here today on behalf of the Animal Health 

Institute, a trade association that represents companies that make 

medicines for animals. 

Our companies share a common mission. We contribute to public 

health by protecting animal health. Animal health products also 

give veterinarians and livestock and poultry producers the necVerDate Nov 24 2008 15:12 Jan 17, 2014 Jkt 037690 PO 00000 Frm 00109 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-25 CHRIS
104 

essary tools to protect the health and well-being of food-producing 

animals. Veterinarians work hard to prevent disease in animals, 

and it is important for them to have the medicines available when 

needed to treat a disease or disease threat. 

Mr. Chairman, the Center for Veterinary Medicine has a rigorous 

science-based approval process that provides to the American public the products necessary to protect public health by protecting 

animal health. Every year scientists uncover new diseases in animals, some of which pose a threat to human health. As more animals are raised to feed the planet and as animals are reared closer 

to people, we will continue to need new medicines to protect animal 

and human health. 

The reauthorization of ADUFA will continue to provide the agency the resources necessary to maintain and improve this approval 

process, provide new and innovative products to allow our pets to 

live longer and healthier lives, and contribute to food safety by 

keeping food animals healthy. 

The FDA animal drug approval process looks much like the 

human drug approval process. Animal drug companies submit data 

packages that demonstrate safety, efficacy, and the ability to meet 

the same stringent FDA manufacturing standards as human medicines. It is a costly process, requiring as much as $100 million and 

7 to 10 years to bring an animal drug to market. 

The market for animal drugs, however, is nothing like the market for human drugs. Our products are used to treat seven different major species of animals and many more minor species. A 

blockbuster animal drug will have sales of around $100 million, but 

the vast majority of animal health products have market sizes of 

around $1 million or less. There is no Medicare or Medicaid—excuse me. I am missing a page. Sorry. I will move right on. 

The reauthorization of ADUFA will continue to provide the agency the resources necessary to maintain and improve this approval 

process, provide new and innovative products to allow our pets to 

live longer and healthier lives, and contribute to food safety. Passage of this important legislation will have several benefits. FDA/ 

CVM benefits by having additional resources to meet its mission of 

protecting public health. Animal health sponsors benefit from a 

stable and predictable review process, allowing them to make informed decisions about the investment risks of research and development dollars. Veterinarians benefit from having new and innovative medical advances available to treat, control, and prevent diseases in their patients. Livestock and poultry producers and the 

veterinarians on whose advice they rely also have the tools to keep 

food animals healthy. Pet owners benefit by having their animals 

live longer and healthier lives, increasing their enjoyment of these 

companions. And consumers reap the food safety benefits that come 

as a result of the availability of additional tools to keep food animals healthy. 

AHI believes that the funding agreed to by the industry over the 

next 5 years is based on an objective assessment of agency resource 

needs and will allow the agency to maintain all current standards 

and also improve performance in key areas. The agreement calls 

for approximately $118 million in funding over the 5 years and 

uses a variable rather than fixed inflation factor, as was mentioned 

105 

today. The financial agreement seeks to reduce the impact that fees 

may have on small businesses and small product markets by reducing the total percentage of fees coming from new animal drug applications and supplemental applications from 25 percent to 20 percent. The agreement also includes a provision for FDA to make up 

potential fee shortfalls that may be experienced by allowing for adjustments to levied fees in the outyears of the program. 

FDA has consistently met timeframes for all sentinel submissions identified in the goals letter, as Dr. Dunham explained, and 

we are confident the agency will continue to do so over the next 

5 fiscal years. The new agreement continues all current submission 

review timeframes mandated in ADUFA II; however, the new 

agreement adds important enhancements to the review process. 

Animal drugs generally go through a phased review process, 

whereas each specific area, called technical sections, of the new 

animal drug application is submitted and reviewed independently. 

Once the technical sections for safety, efficacy, manufacturing, and 

environmental impact are completed, an administrative NADA is 

filed referencing those sections, and approval of the product occurs 

within 60 days. If technical sections can be completed more rapidly, 

it will lead to earlier filing of the administrative NADA and, therefore, reduce overall time to market of safe and effective animal 

medicines. 

Mr. PITTS. Could you wrap up, please? 

Dr. CARNEVALE. Yes. And that will be accomplished by significantly shortening the review times of the second pass submissions. 

There are other agreements that we have talked about today, 

and I will sum by saying that the new agreement commits the 

agency to work with the industry to examine some longer-term 

goals. First, AHI will enter into discussions about how to extend 

conditional approval process and also will take a look at how current animal drug combinations are approved. This could have significant future import with the advent of the FDA proposal to move 

more antimicrobials used in feed to the veterinary feed directive 

program, as was discussed. 

Mr. Chairman, I ask you to pass this legislation in a timely manner and reject any changes that would jeopardize this bill so this 

program can continue without interruption. Thank you very much. 

Mr. PITTS. Thank the gentlemen. 

[The prepared statement of Mr. Carnevale follows:] 

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80810.012

Testimony of Dr. Richard Carnevale 

Vice President, Scientific, Regulatory and International Affairs 

Animal Health Institute 

House Energy and Commerce Committee 

Subcommitee on Health 

April 9, 2013 

Mr. Chairman and members of the Subcommittee: 

Thank you for holding this hearing on this important piece of legislation, and for the opportunity to 

speak to you today about the important human and animal health benefits that result from using 

medicines to keep animals healthy. 

I am Dr. Richard Carnevale. I am a veterinarian by training with a degree from the University of 

Pennsylvania and I am here today on behalf of the Animal Health Institute (AHI), a trade association that 

represents companies that make medicines for animals. Our companies share a common mission: we 

contribute to public health by protecting animal health. With food animals in more demand from our 

growing global population, the importance of the nexus between animal health and human health has 

never been greater, and is one of the driving forces behind the Center for Disease Control's "One 

Health" initiative. As companion animals have become a more important part of our everyday lives 

they have moved from the backyard into our living rooms and bedrooms, increasing their importance to 

humans and requiring greater attention to their health needs. As medical breakthroughs from human 

medicine are adapted to animal medicine, our pets are living longer and healthier lives. 

Animal health products also give veterinarians, and livestock and poultry producers, the necessary tools 

to protect the health and well-being of food producing animals. More and more evidence demonstrates 

that a vital first step in producing safe meat, milk and eggs is keeping animals healthy. Veterinarians 

work hard to prevent disease in animals, but it is important for them to have medicines available when 

needed to treat a disease or disease threat. 

The statutory standard for FDA approval of animal drugs under the Federal Food, Drug and Cosmetic Act 

is the same as that for human drugs: they must be proven to be safe and effective. As a result, the 

animal drug approval process looks much like the human drug approval process: animal drug companies 

submit data packages to demonstrate safety, efficacy, and the ability to meet the same stringent FDA 

manufacturing standards. It is a costly process, requiring as much as $100 million and 7-10 years to 

bring an animal drug to market. In the case of food animals, the standard to ensure that meat, milk, and 

eggs are safe for human consumption adds an additional set of requirements that increases the cost and 

time to market. 
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80810.013

The market for animal drugs, however, is nothing like the market for human drugs. Our products are 

used to treat seven different major species of animals and many more minor species. A blockbuster 

animal drug will have sales of $100 million, and the vast majority of animal health products have a 

market size of around $1 million. There is no Medicare or Medicaid and, except in rare cases, no 

employer supported health insurance -- the cost of animal drugs is borne in full by the animal owner. 

One significant challenge we face in animal health is the declining number of new animal drug 

approvals. The data we collected in preparation for ADUFA III clearly showed that while we significantly 

increased the amount of user fees going to the agency in ADUFA II, the workload has substantially 

declined. There are likely many reasons for this, but a big reason is the ever-increasing regulatory cost 

and burden. In a market as fractured as the animal health market, this increased regulatory burden 

results in fewer live-saving and extending drugs being brought to market. We hope Congress will in the 

future conSider ways to incentivize animal health research and provide for a regulatory environment 

that increases the availability of animal health products. 

Animal health companies rely on a rigorous, efficient, predictable and science-based review process at 

the Food and Drug Administration's Center for Veterinary Medicine (CVM) to provide these products. 

That's why our companies supported the first authorization ofthe Animal Drug User Fee Act ten years 

ago. The Animal Drug User Fee Act of 2003 (ADUFA I) made it possible for our companies to bolster 

funding at CVM so that they could meet performance standards to improve the efficiency and 

predictability ofthe animal drug approval process and ADUFA II, passed in2008, continued that progress. 

Passage of this important legislation will have several benefits: 

1. FDA/CVM benefits by having additional resources to meet its mission of protecting public 

health. 

2. Animal health sponsors benefit from a stable and predictable review process, allowing them to 

make informed decisions about the investment risks of research and development dollars. 

3. Veterinarians benefit from having new and innovative medical advances available to treat, 

control and prevent diseases in their patients. 

4. livestock and poultry producers, and the veterinarians on whose advice they rely, also have the 

tools needed to keep food animals healthy. 

5. Pet owners benefit by having their animals live longer and healthier lives, increasing their 

enjoyment of these companions. 

6. Consumers reap the food safety benefits that come as a result of the availability of additional 

tools to keep food animals healthy. 

AHI believes that the funding agreed to by the industry over the next five years is based on an objective 

assessment of agency resource needs and will allow the agency to maintain all current standards and 

also improve performance in key areas. The agreement calls for approximately $118 million in funding 
108 


80810.014

over the five years, depending on inflation. The funding agreement going forward differs from the 

funding provided over the last five years. AHI has agreed to an annual fee level adjusted by a variable 

rather than the fixed annual inflation factor utilized in ADUFA II. The variable rate will be more closely 

aligned with actual cost increases that FDA might realize from year to year. 

The financial agreement seeks to reduce the impact that fees may have on small businesses and smaller 

product markets by reducing the total percentage of fees coming from new animal drug applications 

and supplements from 25% to 20%. This should result in a substantial reduction in an individual 

application fee in FY 2014 and beyond. The 5% reduction is then distributed among the three remaining 

fee areas - sponsor, product and establishment. Since smaller companies have fewer products and 

facilities, they are hit hardest by the application fee. The agreement also includes a provision for FDA to 

make up potential fee shortfalls that may be experienced by allowing for adjustments to levied fees in 

the out years of the program. 

FDA has consistently met timeframes for all sentinel submissions identified in the goals letter submitted 

to Congress and we are confident that the agency will continue to do so over the next five fiscal years. 

The new agreement continues all current submission review timeframes mandated in ADUFA II. 

However, the new agreement adds important enhancements to the review process. 

The process for reviewing and approving animal drugs has evolved over the years and is somewhat 

different than that for human medicines. Animal drugs generally go through a phased review process 

whereby each specific area called technical sections of the new animal drug application is submitted and 

reviewed independently. Once the technical sections for safety, efficacy, manufacturing, and 

environmental impact are complete an administrative NADA is filed referencing those sections and 

approval of the product occurs within 60 days. 

If technical sections can be completed more rapidly it will lead to earlier filing of the administrative 

NADA and, therefore, reduce overall time to market of safe and effective animal medicines. This will be 

accomplished under the new agreement by FDA agreeing to significantly shorten the review times of the 

second pass submissions that ordinarily are reviewed in the same time frame as the original or first pass 

submissions, when certain criteria in the goals letter are met. Depending on the type of submission this 

can result in up to a four month (120 day) decreased review time and could be critical in moving an 

important animal medicine to the market sooner. 

The new agreement also commits the agency to work with industry to examine longer term goals: 

AHI and FDA will enter into discussions on how to more broadly extend the conditional approval process 

currently available only to minor species to major species applications. The Minor Use/ Minor Species 

Act of 2004 provided a new mechanism for the approval of animal drugs. For minor species or minor 

uses, a sponsor can submit an application to FDA allowing the firm to market the product while 

continuing to collect effectiveness data to satisfy the "substantial evidence" requirement under the 

FD&C Act, as long as enough data has been submitted to allow the agency to determine there is a 

"reasonable expectation" of efficacy before it goes on the market. Of course, the application must still 

meet all requirements for animal, human, and environmental safety, manufacturing quality, and be 
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80810.015

properly labeled prior to marketing. The conditional approval lasts for five years after which time the 

product is fully approved or withdrawn from the market if the sponsor fails to demonstrate substantial 

evidence. 

AHI believes that a strong case can be made to extend this provision to certain drugs proposed for major 

species other than those specifically for minor use. This allows earlier marketing of important products 

that can be studied and thoroughly tested for effectiveness because the sponsor is adding revenue to 

fund such studies. The data gathered under a conditional approval will be much more robust and allow 

the agency to have better confidence in the safety and effectiveness of the product before it issues final 

approval. The advantage to FDA is that it can easily terminate the marketing of a product if the sponsor 

fails to complete the data commitment. There is no increased risk to animal for public health since 

safety will be assured prior to marketing. Additionally, conditional approvals are currently in place at 

USDA, which regulates animal vaccines and at EPA, which regulates flea and tick products for animals. 

Conditional approvals could be one mechanism to address the current decline in animal drug 

submissions and bring much needed new product development to the market for major species. 

The other policy issue that will be discussed under the new agreement will be the issue of combination 

medicated feed new animal drug approvals. It is common practice in the field to combine two or more 

drugs in a medicated feed being given to cattle, pigs, or poultry. For the past 40 plus years FDA has 

required that two or more approved drugs added to an animal feed must first also be approved by the 

agency before they can be mixed concurrently. There is a long history of FDA requiring this and dates 

back to a policy first established in the 1960's that considered animal feeds containing an animal drug to 

be a finished drug formulation. A producer or feed manufacturer can only combine approved animal 

drugs in feed if an application for that combination has been approved by FDA. Therefore, an animal 

drug sponsor obtaining an approval for a drug to be added to animal feed is responsible for filing 

additional new animal drug applications providing for the concurrent mixing in the feed of the newly 

approved drug with other approved drugs. These are essentially administrative NADA's that simply 

reference the approvals of the other products but still require submission of some limited data and new 

labeling. 

This has been an onerous requirement since it can significantly delay the ability of a sponsor to market a 

new product because the sponsor may not submit these other application for review and approval by 

FDA until the new drug is first approved. Some relief was realized in 1996 at the passage of the Animal 

Drug Availability Act, which lessened the requirements for the approval of these combination 

applications, but did not eliminate the need to submit an NADA for these combinations. Experience has 

shown since the ADAA that few problems can be identified by the mixing of two or more approved drugs 

concurrently in the feed in the way of interference with the active ingredients or with changes to animal 

safety or human food residues. 

FDA has agreed to enter into discussion with the animal drug and animal feed industry and state 

regulatory authorities overseeing animal feed manufacturers over the next 3 years to determine how 

these requirements might be modified. This could have significant future importance with the advent of 

the FDA proposal to move more antimicrobials used in feed to a Veterinary Feed Directive program by 
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80810.016

allowing for veterinarians to more efficiently write VFD orders for antibiotics to be mixed into feed with 

other non-VFD drugs. Eliminating the requirement for combination feed approvals could pave the way 

for a smoother implementation of the VFD program and ensure that antimicrobials added to feed are 

being use for therapeutic purposes only under the order of a veterinarian. 

Mr. Chairman, CVM has a rigorous, science-based approval process that provides to the American public 

the products necessary to protect public health by protecting animal health. Every year scientists 

uncover new diseases in animals, some of which potentially pose a threat to human health. As more 

animals are raised to feed the planet and as animals are reared closer to people, we will continue to 

need new medicines to protect animal and human health. 

The reauthorization of ADUFA will continue to provide the agency the resources necessary to maintain 

and improve this approval process, provide new and innovative products to allow our pets to live longer 

and healthier lives and contribute to food safety by keeping food animals healthy. I urge you to pass this 

bill in a timely manner and reject any changes that would jeopardize this bill so this program can 

continue without interruption. 

Again, thank you for holding this hearing and I would be happy to answer any questions. 
111 

Mr. PITTS. Recognize Dr. Apley, 5 minutes for opening statement. 

STATEMENT OF MIKE APLEY 

Dr. APLEY. Mr. Chairman and members of the committee, good 

afternoon, I am Mike Apley. I am a veterinarian—— 

Mr. PITTS. Is your mike on? Yes. 

Dr. APLEY. Got it. Thank you. 

I am Mike Apley. I am a veterinarian and a clinical pharmacologist at Kansas State University College of Veterinary Medicine, 

with friends at North Carolina and Colorado. 

Mr. SHIMKUS. What about Illinois? 

Dr. APLEY. Some up there, too. 

My specialty areas are food animal production and the use of 

drugs in these animals. Today I wanted to share with you a little 

bit about how drugs are used in food animals. 

The first thing I wanted to emphasize is that this use revolves 

around the relationship of veterinarians to food animal producers. 

Veterinarians are a vital part of the drug use decisions by food animal producers, especially for antibiotics. This relationship is described and promoted in programs such as beef quality assurance 

and pork quality assurance. The combination of close monitoring 

and knowledge of the animals by the producer with the training 

and experience of the veterinarian is the best possible approach to 

animal health. 

Antibiotics may receive approval by the FDA Center for Veterinarian for five indications: treatment of disease, prevention of disease, control of disease, improved feed efficiency, and improved rate 

of gain. Those last two indications are production uses, which may 

also be referred to as growth promotion claims. These claims are 

specifically referred to in FDA Guidance for Industry 209, which 

Dr. Dunham referred to, in which FDA/CVM refers to these indications as injudicious uses and asks for voluntary withdrawal of 

these indications. 

While the FDA has not released official definitions for indications 

2 and 3, which were prevention and control, that I am aware of as 

yet, as a clinical pharmacologist I wanted to share my working 

definitions of these applications. Prevention is the use of an antibiotic to prevent disease occurrence in a population of animals 

when experience suggests that this particular time in a production 

cycle is very likely to result in a disease outbreak in this population of animals. The need for prevention varies according to the 

current disease pressure and may change over time. Control, on 

the other hand, is use of an antibiotic to reduce the number of additional clinical cases in a population where clinical observation or 

recent stressors and exposure indicate that the disease process is 

clinically apparent or in development. 

The overarching goal of veterinarians and producers is to replace 

the need for prevention or control uses of antibiotics through practices such as biosecurity and vaccinations. The use of antibiotics for 

therapy and control are considered a therapeutic use by the American Veterinary Medical Association, the FDA Center for Veterinary Medicine, the World Organization for Animal Health, and 

Codex Alimentarius. 

112 

In my submitted testimony, I have included tables of labels for 

cattle and swine. My first table summarizes uses that are labeled 

for improvement of rate of gain or feed efficiency, with the emphasis on ones that would be affected by Guidance 209. For antibiotics 

in cattle with labels strictly for improvement of rate of gain or feed 

efficiency, there are four which are not classified as human medically important and five which are. There are some labels which 

have a rate of gain or feed efficiency claim and a prevention or control claim. In that category, there is one which is not medically important and three that are. These claims are examples of ones that 

would be affected by the removal of growth promotion claims. 

When we move to prevention or control of disease only, there are 

only three out of eight which are medically important. 

I would also like to emphasize the findings of a study in which 

I was lead author, which addressed the use of antibiotics in the 

feed for swine. In this study, it was found that approximately 15 

percent of the medically important antibiotic use in feed for swine 

was for growth promotion. The greatest use on a kilogram basis of 

the medically important antibiotics in swine was attributable to the 

tetracyclines, which are chlortetracycline and oxytetracycline in 

these cases. 

As for cattle, there are other antibiotics, which have an injectable 

or in-water route of application on the label. These include 

ceftiofur, ampicillin trihydrate, tulathromycin, penicillin G. This illustrates the complexity of this issue and the need to evaluate our 

discussion based on these different antibiotics and pathogens of interest. 

Lastly, if they are to be used other than according to the label, 

there must be a veterinarian involved, and this would include any 

changes in dose, duration, or disease indications. Provisions are 

available to allow some extralabel use in feed and minor food animal species, but for major food animal species, any extralabel use 

in the feed is illegal. 

Thank you for the opportunity to be here today, and I will answer questions as they come. 

Mr. PITTS. The chair thanks the gentleman. 

[The prepared statement of Mr. Apley follows:] 

113 


80810.017

Testimony to the House Energy and Commerce Committee 

Subcommittee on Health 

"Reauthorization of Animal Drug User Fees: ADUFA and AGDUFAIJ 

April 9, 2013 

Michael D. Apley, DVM, PhD 

Professor, Kansas State University College of Veterinary Medicine 
114 


80810.018

Note: In this testimony, the common term antibiotic is used to represent both antibiotics and 

antimicrobials. 

Summary: 

Uses of antibiotics in food animals are highly regulated, starting with specific indications on the label. 

Currently, the indications may include treatment, prevention, or control of disease, improved feed 

efficiency, and improved rate of gain. The FDA!CVM has indicated through Guidance for Industry #209 

that indications on labels for medically important antibiotics which include feed efficiency and rate of 

gain are to be removed from the labels. This guidance also indicates the intention to require veterinary 

authorization for all feed and water uses of antibiotics in food producing animals. The remaining label 

indications (treatment, prevention, and control) are therapeutic uses. 

Antibiotics labeled for administration in the feed must be used only for label directions, any other use is 

illegal. Any extralabel use of other food animal antibiotics must meet the strict requirements of the 

Animal Medicinal Drug Use Clarification Act regulations, including strict oversight requirements for 

veterinary involvement as well as standards for rationale for this use. 

Examples of antibiotic approvals for cattle and swine indicate that there is a wide variety of antibiotics 

approved for use with varying indications. A 2012 estimate of 2006 swine in-feed antibiotic use 

indicates that approximately 20% of in-feed antibiotic use of classes medically important in human 

therapy was attributable to growth promotion uses. 
115 


80810.019

The Relationship of Veterinarians to Food Animal Producers 

Veterinarians are a vital part of the drug-use decisions by food animal producers, especially for 

antibiotics. This relationship is described and promoted in programs such as beef quality assurance and 

pork quality assurance. 

Label Indications for Uses of Antibiotics in Food Animals 

Antibiotics may receive approval by the FDA Center for Veterinary Medicine for these indications 

1. Treatment of disease 

2. Prevention of disease 

3. Control of disease 

4. Improved feed efficiency 

5. Improved rate of gain 

Indications 4 and 5 are production uses, also referred to as growth promotion claims. These claims are 

specifically referred to in FDA Guidance for Industry #209, in which the FDA/CVM refers to these 

indications as injudicious uses and asks for voluntary withdrawal of these label approvals by the 

sponsors (GFI #209, 2012). The initial time frame for withdrawal of these indications is 3 years after the 

mechanisms for label revision are established in the form of FDA Guidance for Industry #213 (GFI #213, 

2012). Guidance for Industry #213 is intended to provide streamlined methods for removing these 

claims and adding veterinary oversight to all feed and water uses of antibiotics in food animals (which 

are also specified as an intended change in Guidance for Industry #209). The FDA/CVM has indicated 

that they may alter this time frame if necessary, but will take regulatory action to remove these label 

claims if voluntary removal does not occur. 
116 


80810.020

While the FDA/CVM has not released official definitions for indications 2 and 3, as a clinical 

pharmacologist, my working definitions in the field are as follows. 

• Prevention: Use of an antibiotic to prevent disease occurrence in a population of animals when 

experience suggests that this particular time in the production cycle is very likely to result in a 

disease outbreak in a population of animals. The need for prevention varies according to the 

current disease pressure in the population, therefore the need for this preventive practice may 

vary over time. 

• Control: Use of an antibiotic to reduce the number of additional clinical cases in a population 

where clinical observation or recent stressors and exposure indicate that the disease process is 

clinically apparent or in developmental stages in some ofthe animals. Treatment at this time 

will interfere with advancement from the incubatory stage to the clinical stage of disease. 

The overarching goal of veterinarians and producers is to replace the need for prevention or control 

uses of antibiotics through practices such as biosecurity and vaccination. Uses of antibiotics for therapy 

and control are considered a therapeutic use by the American Veterinary Medical Association, the FDA 

Center for Veterinary Medicine, the OlE (World Organization for Animal Health), and Codex Alimentarius 

(International Food Standards). 

Cattle antibiotic labels include a wide variety of indications. Table 1 summarizes in-feed labels by type 

of indication. These indications are for different diseases and represent different dosing regimens 

intended for different ages use classes of cattle. This table is for summary purposes only. Summaries of 

label inclusions for FDA/CVM-approved drugs for all veterinary species may be accessed through a 

search engine on the FDA/CVM website (Animal Drugs @ FDA, 2013). 
117 


80810.021

Table 1. Examples of in-feed approvals for antibiotics in cattle. These approvals are not ranked by 

frequency or amount of use. Shaded drugs indicate individual antibiotics or antibiotic combinations 

which contain a medically important antibiotic as defined in Food and Drug Administration Guidance for 

Industry #152, Appendix A (GFI #152, 2003) for which the rate of gain and/or feed efficiency label 

indication will be affected by FDA/CVM GFI #209. 

Bacitracin Zinc 

Prevention or control of disease only 

Amprolium 

Bacitracin methylene disalicylate 

Chlortetracycline 

Decoquinate 

lasalocid 

Monensln 

Tylosin 

Virginiamycin 
118 


80810.022

Table 1 (continued): 

Treatment of disease and prevention or control 

Neomycin 

Neomycin / oxytetracycline 

Oxytetracycline 

Sulfaquinoxaline 

Tetracycline 

Treatment of disease only 

Amprolium 

Chlortetracycline 

Oxytetracycline 

Sulfachlorpyridazine 

Sulfamethazine 

Sulfadimethoxine 

Table 2 gives examples of antibiotics labeled for cattle which may be administered by the water 

(individually or to a group) or which are administered individually to cattle either by injection or by 

administration in the mammary gland for mastitis (lMM). As for Table 1, the list does not imply extent 

or amount of use. 
119 


80810.023

Table 2: Injectable, intra mammary, and water antibiotics for cattle. The vast majority of these require a 

veterinary prescription. 

Class Antimicrobial Route 

Thiamine analog Amprolium 

Oral in water or as a 

drench 

Amoxicillin IMM 

Ampicillin trihydrate Injectable 

Penicillins 

Cloxacillin IMM 

Hetacillin IMM 

Penicillin G procaine Injectable,IMM 

Penicillin G procaine / Benzathine Injectable 

Cephalosporins 

Ceftiofur Injectable and IMM 

Cephapirin IMM 

Oxytetracycline Injectable and in 

Tetracyclines water 

Chlortetracycline Oral as bolus 

Fluoroquinolones 

Danofloxacin Injectable 

Enrofloxacin Injectable 

Phenicols Florfenicol Injectable 

Dihydrostreptomycin IMM 

Aminoglycosides Gentamicin Ocula r spray 

Neomycin Oral In water/milk 

Sulfachlorpyridazine Injectable 

Sulfamethazine Oral as bolus 

Sulfas (all non- Sulfamethazine Injectable 

potentiated) Injectable, oral as 

Sulfadimethoxine drench, in water, or 

bolus 

Gamithromycin Injectable 

Tildipirosin Injectable 

Macrolides Tilmicosin Injectable 

Tulathromycin Injectable 

Tylosin Injectable 

Aminocoumarin Novobiocin IMM 

Lincosamides Pirlimycin IMM 
120 


80810.024

An estimate of in-feed use of antibiotics in swine was recently published, in which I served as lead 

author (Apley, et aI., 2012). This estimate utilized the USDA National Animal Health Monitoring System's 

Swine 2006 Survey data in conjunction with a veterinary swine practitioner survey to estimate the 

amount of antibiotics use in swine feed for the year 2006. The following table is reproduced from this 

publication. 

I ABU;:; :\JATlO"':.:"l r~jT\t..~H SWl'\T h:-f ffD A,Tl\H(ftOBlA, c:; 

fOR Au. rfWIJLCTIO:\ ClOP, I.' A \!",AR U\ ASII~U(,rKHJlAt AX" RL!>"'O~ 

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':;.:;:;1 '112 14,07:; 

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From this table it is evident that of the antibiotics listed as either highly important or critically important 

in FDA/CVM GFI #152, Appendix A, the estimate indicates that 15% was used for growth promotion 

purposes. The greatest use, on a kg basis, was attributable to the tetracyclines (chlortetracycline and 

oxytetracycline). 
121 


80810.025

As for cattle, there are other antibiotics which have an injectable or in-water route of application on the 

label. These include ceftiofur, ampicillin trihydrate, tulathromycin, Procaine penicillin G, oxytetracycline, 

chlortetracycline (water only), tetracycline (water only), and enrofloxacin. 

Use Other than According to the Label 

Use of antibiotics in the feed for major food animal species in any manner other than specified on the 

label is illegal. This would include any changes in dose, duration, or disease indication. Provisions are 

available to allow some extra label use in minor food animal species (e.g., sheep and goats) (FDA, 2007). 

Any other extralabel use of antibiotics in food animals must be done in compliance with the Animal 

Medicinal Drug Use Clarification Act regulations (AMDUCA, 1994). These regulations require that a 

veterinarian prescribes the use within the confines of a valid veterinarian-client-patient relationship and 

that an extended withdrawal time be used as specified by the veterinarian. 

Extralabel use of fluoroquinolones in food animals is prohibited by the FDA/CVM, along with other drugs 

on a list which is a standard knowledge base for all veterinarians (CFR 530.41,2012). This extralabel use 

prohibition includes cephalosporins, with the exception of cephapirin, which may be used in an 

extra label manner only for disease indication, with no allowable alteration of the dosing regimen (dose 

and route, duration, or frequency of administration). 

References 

AMDUCA 1994. Animal Medicinal Drug Use Clarification Act of 1994. Accessed 4-8-2013 at 

http:Uwww.fda.gov/AnimaIVeterinary/GuidanceComplianceEnforcement/ActsRulesRegulations/ucm08 

5377.htm 

Animal Drugs @ FDA, 2013. Accessed 4-8-2013 at http://www.accessdata.fda.gov/scripts/ 

animaldrugsatfda/. 

Apley MD, Bush EJ, Morrison RB, Singer RS, Snelson H. 2012. Use estimates of in-feed antimicrobials in 

swine production in the u.s. Journal of Foodborne Pathogens and Disease, 9:272-279. 

CFR 530.41, 2012. Code of Federal regulations Section 530.41- Drugs prohibited for extra label use in 

animals. Accessed 4-8-2013 at http://www.gpo.gov/fdsys/pkg/CFR-2012-title21-voI6/xmI!CFR-2012-

title21-voI6-sec530-41.xml. 

FDA 2007: Food and Drug Administration Center for Veterinary Medicine. "FDA Clarifies Extra-label use 

of medicated feed in minor species per CPG #615.11" Accessed 4-8-2013 at http://www.fda.gov/ 

AnimaIVeterinary/NewsEvents/CVMUpdates/ucm048037.htm. 

GFI #209, 2012. Food and Drug Administration Center for Veterinary Medicine, Guidance for Industry # 

209. The Judicious Use of Medically Important Antimicrobial Drugs in Food-producing Animals. April 19, 

2012. Accessed 4-8-2013 at http://www.fda.gov/downloads/AnimaIVeterinary/ 

GuidanceComplianceEnforcement/Guidanceforlndustry/UCM216936.pdf. 
122 


80810.026

GFI #152, 2003. Food and Drug Administration Center for Veterinary Medicine, Guidance for Industry # 

152. Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological 

Effects on Bacteria of Human Health Concern. Accessed 4-8-2013 at http://www.fda.gov! 

downloads!AnimaIVeterinary!GuidanceComplianceEnforcement!Guidanceforlndustry!UCM052519.pdf. 

GFI #213, 2013. Food and Drug Administration Center for Veterinary Medicine Guidance for Industry 

#213, Draft Guidance, April 13, 2012. New Animal Drugs and New Animal Drug Combination Products 

Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations 

for Drug Sponsors for Voluntarily Aligning Product Use conditions with GFI#209. Draft Guidance for 

comment purposes only. Accessed 4-8-2013 at http://www.fda.gov/downloads/AnimaIVeterinary( 

GuidanceComplianceEnforcement/Guidanceforlndustry/UCM299624.pdf. 
123 

Mr. PITTS. And now recognizes Dr. Price 5 minutes for an opening statement. 

STATEMENT OF LANCE B. PRICE 

Dr. PRICE. Chairman Pitts, Ranking Member Pallone, and the 

members of the Health Committee, thank you for this opportunity. 

My name is Lance Price. I am a professor of occupational and environmental health at George Washington University here in D.C., 

where I study the connection between antibiotic use in food animal 

production and antibiotic-resistant infections in people. As such, I 

am here to testify that we need to know more about the antibiotics 

that we are using in food animal production. 

First, let me thank you for giving us the 2008 ADUFA amendments that have shed some light on the gross quantity of antibiotics being sold through food animal producers. However, today’s 

antibiotic resistance crisis forces me to ask you for even more detailed information in the 2013 reauthorization. 

Antibiotic resistance is one of the greatest threats that we face 

as a Nation. Tens of thousands of Americans’ lives are lost each 

year due to antibiotic-resistant infections, and we have no choice 

but to act swiftly and aggressively to meet this enormous public 

health challenge. The victims of this crisis have names, like Carlos 

Don, a boy who died 2 weeks before his 13th birthday of a drugresistant infection. The victims are also the parents who pace helplessly in hospital rooms while doctors struggle and eventually fail 

to find an antibiotic to treat their sick children. 

Sadly, we fail these victims even now, because we know how to 

control resistance, but we have taken insufficient action to do so. 

We control resistance by reducing antibiotics in hospitals and in 

clinics, but also, and importantly, we control resistance by reducing 

antibiotic use on our industrial farms. For as long as we have 

known about antibiotics, we have known that the more we use 

them, the more likely we are to have resistance, but despite this 

knowledge, we continue to use antibiotics as cheap production tools 

on our industrial farms. And I would like to be clear: We do need 

antibiotics to treat sick animals, but using them routinely for nontherapeutic purposes threatens animal and human health alike. 

Our own FDA, the agency that is charged with protecting human 

health and charged with regulating antibiotics in food animals production, tells us that our food supply is riddled with antibiotic-resistant bacteria. Let me show you what the FDA tells us about 

drug-resistant bacteria in our food supply. These are the ADUFA 

reports since 2009. And what they tell us is that our food supply 

is full of drug-resistant bacteria. They show that half of the ground 

turkey products on our grocery store shelves are contaminated with 

multidrug-resistant E. coli, including some strains that are resistant to our most important antibiotics, such as cephalosporin. In the 

2010 report, they showed a strain of salmonella that was resistant 

to all the antibiotics that they tested. 

Now let me show you what we know about antibiotic use in food 

animal production. Here are the ADUFA reports. So here are the 

drug-resistant bacteria in our food supply, here are the ADUFA reports reporting on the drugs that are used in food animal production. The ADUFA reports tell us that 30 million pounds of antiVerDate Nov 24 2008 15:12 Jan 17, 2014 Jkt 037690 PO 00000 Frm 00129 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-25 CHRIS
124 

biotics are being used in food animal production each year, but 

they tell us little else. They don’t tell us how antibiotics are being 

divided up among the major animal species, whether they are sold 

over the counter or under veterinary order, or the proportion of 

antibiotics sold for nontherapeutic purposes. We need this information and we need our FDA to give us more. 

The FDA has offered only voluntary guidelines to eliminate the 

most egregious use of antibiotics: growth promotion in food animal 

production. In response to criticisms that these voluntary guidelines are weak, the FDA Deputy Commissioner, Mike Taylor, said 

that the FDA would trust, but verify compliance. Unfortunately, 

without more detailed data collection, the FDA will lack the information it needs to verify, leaving them only to trust. The time to 

verify is now and the time for more detailed data collection is now. 

ADUFA is the perfect bill for requiring additional data collection 

for three reasons: ADUFA is now, ADUFA is about drugs used in 

food animal production, and ADUFA already authorizes the FDA 

to collect some high level data via Section 105. With these data, we 

can assess the impact of FDA’s voluntary guidelines, we can identify places where improvements can be made, and hopefully we can 

confirm industry claims that antibiotics are being used more sparingly. 

This is an issue about transparency, it is about accountability, 

but most of all it is about public health. We need to act now to protect American lives. So as a public health researcher, a microbiologist, and a citizen of this country, I implore you to require more 

detailed data collection and reporting from the FDA, including how 

the antibiotics are being used divided up among those major animal species, whether they are sold over the counter or under veterinary control, and the proportion of antibiotics sold for growth 

promotion, disease prevention, control and treatment, such as the 

provisions included in the DATA Act, H.R. 820, sponsored by Ranking Member Waxman and Congresswoman Slaughter. 

In closing, I would like to thank you for your time and for giving 

me the opportunity to testify on such a critical issue. 

Mr. PITTS. The chair thanks the gentleman. 

[The prepared statement of Mr. Price follows:] 

125 


80810.027

Testimony before the 

House Committee on Energy and Commerce, Subcommittee on Health 

United States House of Representatives 

April 9, 2013 

Lance B. Price, Professor, Department of Environmental and Occupational Health, 

The George Washington University 

Chairman Pitts, Ranking Member Pallone and members of the Health Subcommittee, thank you 

for the opportunity to give testimony about the steps Congress must take to shine a light on antibiotic use. 

I am grateful that today's hearing on the Animal Drug User Fee Act (ADUFA) will include a 

discussion of the issue of antibiotic resistance and, more specifically, Section 105 of the 2008 ADUFA 

amendments, which requires the Food and Drug Administration (FDA) to collect and report data from 

animal-drug manufacturers on the sale of antibiotics intended for use in food animal production. As a 

public health researcher with years of experience examining the relationship between antibiotic use in 

food animals and antibiotic-resistant infections in people, I strongly believe the public needs to know 

more about how and why antibiotics are used on food animals to produce meat and ponltry. For this 

reason, I support the Delivering Antimicrobial Transparency in Animals (DATA) Act (H.R. 820), 

introdnced by Representatives Waxman and Slaughter, to broaden and deepen understanding regarding 

this public health threat, and to inform the policymaking process at FDA and in Congress. 

As a microbiologist, I have dedicated my career to studying bacteria. I'm fortunate to be doing so 

during a golden age of DNA sequencing technology. Quickly and cheaply, we can now map the entire 
126 


80810.028

genomes of bacteria that infect people and use that information to determine where they are coming from. 

And the results tell us conclusively that using antibiotics on industrial farms is a danger to human health. 

My colleagues and I have published numerous journal articles showing that exposing bacteria to 

antibiotics breeds drug-resistant superbugs, that these bacteria are prevalent on our meat and poultry, and 

that the germs do in fact spread from animals to people where they cause infection. 

It is undisputed that using antibiotics-appropriately or inappropriately-is the single most 

powerful force leading to the development of antibiotic-resistant bacteria that poses an immediate threat 

to the public's health. We cannot stop using antibiotics altogether because we need them to treat 

infections. What we can do, however, is reduce inappropriate use and slow the evolution of resistant 

bacteria. Hospitals across the country are implementing stewardship programs with the goal of reducing 

antibiotic use and curbing resistancc. For years, thc Centers for Disease Control and Prevention (CDC) 

has been undertaking a campaign called Get Smart About Antibiotics to promote more responsible 

prescribing and use among people. A key component of these programs is data collection. Doctors, 

pharmacists and hospital administrators are tracking antibiotic use prescription by prescription, noting 

when, where and for what diseases these drugs are being nsed. Because there is good data in human 

medicine, they know how antibiotic use is changing, how use contributes to resistance, where problems 

persist, and what targeted interventions will work best to address remaining issues. According to the CDC 

National Center for Emerging and Zoonotic Infectious Diseases, in 2011, there was a 25 perccnt reduction 

in the number of people developing healthcare-associatcd invasive MRSA infections'. And the American 

Academy of Pediatrics recently reported on a 40 percent reduction in cephalosporin-resistant Klebsiella 

infection and a 70 percent reduction in intensive care units. 

But even if every hospital and every doctor participated in a stewardship program and tracked the 

usc of all human antibiotics, we still would fail to understand the vast majority of antibiotic use taking 

place in this country-that is, the use of these drugs on industrial farms. 
127 


80810.029

About two months ago, the Food and Drug Administration reported that, in 2011, drug companies 

sold nearly 30 million pounds of antibiotics for use in food animal production-the highest amount the 

agency has reported. The agency broke down these sales into eight drug classes and an "other" category 

aggregating the sales of several additional classes. While this infonnation is helpful in illustrating the 

overall scope of antibiotic sales for meat and poultry production, it does not provide enough detail. In 

order to protect public health and animal well-being, we must also know why, how and in what animals 

these vital drugs are used. 

First, we need to know to which animals antibiotics are being administered. Each year, the FDA 

measures the prevalence of superbugs on retail meat and poultry and finds considerable differences 

between what's on ground turkey, retail chicken, pork chops and ground beef. Bacteria on some products 

exhibit much higher rates of resistance than the same kinds of bacteria on other products. Understanding 

how antibiotics are intended to be used in each species can shed light on the superbugs that vary so 

significantly by product. 

Second, we need to know why antibiotics are being used-that is, how often they are sold for 

non-therapeutic production purposes like growth promotion and disease prevention or for therapeutic 

purposes like disease control and treatment. Last April, the Food and Drug Administration issued a draft 

set of voluntary guidelines designed to eliminate the use of antibiotics to accelerate the growth of healthy 

animals. The agency's deputy commissioner for food, Mike Taylor, said in a USA Today op-ed to critics 

who thought this voluntary approach had no teeth that the FDA would "trust, but verify" that these 

policies are working. But if the FDA does not know how often antibiotics are being used to promotc 

growth or compensate for overcrowded and unsanitary living conditions, it cannot verify progress. 

Complicating matters, the animal-drug industry has stated explicitly that it would seek replacement 

indications for product labels, essentially swapping "growth promotion" indications for "disease 

prevention," which could be virtually identical in practice. These practices pose a particular threat to 

human health because they involve low-dose antibiotics, which can do more hann than therapeutic doses. 
128 


80810.030

They create an environment for bacteria that is just hostile enough to prompt them to develop resistance 

but not so harsh that they are killed off. Only with more data can the FDA truly verify that its policies are 

having a real effect on actual usage and not just on labeling. 

Drug manufacturers should have some estimates of this species and intended use information. 

But the best information might come from feed mills, which are responsible for mixing antibiotics into 

animal feed for various purposes, either by order of a veterinarian, or per the request of producers or 

large-scale meat production companies. Congrcss should explicitly authorize FDA to require uniform 

annual rcporting of these data from the largest feed mills or, if easier, from top meat production 

companies who are purchasing the antibiotics to be distributed to their growers in feed. 

Third, we need more precise data that provides details on antibiotics important in human 

medicine. In the FDA's reports, it includes an "other" category that aggregates sales of antibiotic classes 

in which there are fewer than three companies selling products. This is intended to protect proprietary 

data, but it is unnecessarily broad. The FDA should divide this category into two components--one 

tallying sales of antibiotics used only in animals and another for sales of drugs used in humans and 

animals. 

Fourth, the FDA should report how antibiotics are intended to be administered-such as, in feed, 

in water or by injection-both in total and by drug class. The FDA provided this infonnation at the 

request of Representative Slaughter after the agency released its 2009 sales report and it should become a 

standard element of the agency's annual sales summary. It was from this information that we learned that 

74 percent of antibiotics are administered in feed and 16 percent in the water. Route of administration 

does not definitively indicate why drugs are used, but the widespread administration of antibiotics in feed 

suggests that large groups of animals are routinely and indiscriminately being fed antibiotics they may not 

need, which may indicate that there are deeper, underlying production problems needing to be addressed. 
129 


80810.031

As a microbiologist who is committed to public health, I must express deep frustration with the 

Food and Drug Administration. The agency's core mission is to protect the public's health, yet it is not 

doing nearly enough to monitor antibiotic practices that it knows are dangerous and injudicious. It 

negotiated an agreement to collect fees from drug makers in exchange for expediting drug approvals, 

while missing a prime opportunity to seek some common-sense provisions to simply measure-not 

restrict, just measure-the use of antibiotics. The agency has been in possession of data that would shed 

more light on how antibiotics are being used on industrial farms, but it has declined to share it in 2010 

and 2011. FDA notes that it has the authority to collect more data but has not exercised it. Instead, the 

agency has initiated a years-long potential rulemaking process to further explore the question of data 

collection, a process that, unfortunately, will keep the public in the dark for at least a few more years, 

with no clear light at the end of the tnnne1. Congress has the opportunity to direct FDA to do a better job, 

and to prioritize data collection and stewardship of antibiotics the agency approves. 

I am grateful to this committee for considering the issue and I ask you to hold the FDA 

accountable. As this committee did five years ago, please seize this opportunity and allow the public to 

know more about how our food is produced and how antibiotics needed to safeguard human and animal 

health are being used on industrial farms. Please include additional antibiotics data collection provisions 

in the Animal Drug User Fee Act. 

Thank you. 

i h,tp:i/myw.cdc.gQVlnrez;!:l/pdflanmml:reP9[t.pdf; accessed 3/3/13. 
130 

Mr. PITTS. That concludes the opening statements of the panelists. I will begin the questioning and recognize myself 5 minutes 

for that purpose. 

Dr. Carnevale, what are some of the benefits of ADUFA and 

AGDUFA to livestock, poultry producers, veterinarians, pet owners, 

consumers? And why have ADUFA and AGDUFA been so successful? 

Dr. CARNEVALE. Well, as you heard today, there is a really great 

need for new products for both livestock and pets and horses and 

other species as well. Getting a drug approved is a very expensive 

process, as I mentioned in my testimony. What ADUFA and 

AGDUFA does is allows the company to have more certainty with 

the agency about how the product will be reviewed and the timeframes for that approval. 

It doesn’t give any certainty that the product will be approved. 

All the standards for safety and efficacy are still maintained. It 

simply gives the manufacturer a better idea of, if they invest the 

amount of money it takes to get a product approved, they will have 

the FDA do an efficient job of reviewing that product, and if the 

data supports it, it will be approved. 

So it helps to have these drugs out there faster for the livestock 

owner that needs those treatments. ADUFA will help get those 

products to market faster. It will help the pet owner as well to get 

products in the hands of his small animal veterinarian faster so 

that these products can be used. And it just enhances the whole efficiency of getting these products on the market. 

Mr. PITTS. What are, in your opinion, the most important improvements in the user fee agreements that we are talking about 

today? 

Dr. CARNEVALE. I think the important improvement is that we 

have maintained a reasonable cost basis. I think one of the things 

that we were concerned about going into ADUFA III was the cost 

of the program, the escalating cost of the user fee program, in addition to the cost of development. 

We were able to do a very good objective assessment of what the 

costs should be, and I think we are compensating FDA for the 

needed costs that they have in running the program, but not overpaying. So I think that is one of the benefits that came out of the 

negotiation. 

Also, we were able to get them to enhance the process. I mentioned second pass reviews. It will allow those second pass, the second time the submission comes into the agency to maybe have a 

shorter timeframe, to speed that administrative approval process. 

So there are some significant benefits. We also got the agency to 

agree to look at some long-term changes in the process that might 

help to get products to the market sooner. 

Mr. PITTS. Do you feel, in light of the testimony we have heard 

today, that the FDA review process as it exists today protects animal and public health? 

Dr. CARNEVALE. There is no question it does. It is a very rigorous 

process. I used to work at the agency a number of years ago. I 

know how rigorous the process is that takes place at the Food and 

Drug Administration. As I mentioned, the data requirements are as 

great, if not more, for animal drugs, particularly food animal drugs, 

131 

than they are for human medicine. FDA protects animal health to 

the utmost extent. 

Mr. PITTS. Thank you. 

Doctor—— 

Dr. CARNEVALE. Human health as well. 

Mr. PITTS. Dr. Apley, can you please elaborate on the role of veterinarians in animal drug development and drug use decisions? 

Dr. APLEY. In animal drug development, as a practicing veterinarian, previously I had the opportunity to interact with companies 

and interact on needs that drove research and development, which 

was very valuable for all of us. 

As a veterinarian that guides use, one of our most important 

things we do is work with producers to develop protocols and establish those protocols. And to show you how far that goes, in my days 

as a feedlot consulting veterinarian, we actually had computerized 

records, and each animal that was treated was individually identified. And one of the first things I did each time I visited, twice a 

month, to train and monitor records was to go through the individual animal treatment records and determine what our treatment response was, if we were doing things appropriately. And we 

had a protocol that could change, but the only way it could change 

was if we all agreed on it. 

Mr. PITTS. In your opinion, does the FDA have the authority to 

appropriately address antibiotic issues? 

Dr. APLEY. In my opinion, they do. I have worked with them as 

a veterinarian and as a member of both producer and veterinary 

organizations. They are very good, in my opinion, about seeking 

our input and also evaluating what is going on out in the field. 

Mr. PITTS. And do you think the reauthorization of these user fee 

programs will foster animal drug development? 

Dr. APLEY. I do, yes. 

Mr. PITTS. My time has expired. Thank you very much. Recognize the ranking member of the subcommittee, Mr. Pallone, 5 minutes for questions. 

Mr. PALLONE. Thank you, Mr. Chairman. 

I wanted to ask Dr. Price about your testimony regarding antibiotic resistance. Although this committee has looked at this issue 

repeatedly in the past, we do have some new members who did not 

get to participate in our prior hearings, and for those of us who 

were around, it might help to get a refresher. First of all, can you 

describe how resistance develops for us? 

Dr. PRICE. Sure. So what we are talking about are bacteria that 

are resistant to the effects of antibiotics, right, and those bacteria 

can cause infections in people and those infections are harder to 

treat. 

The way bacteria become resistant to antibiotics are through 

mutations in the DNA, but also by picking up genes from other 

bacteria. And these things are promiscuous, you know, the 

Berlusconis of the biological world, and they pass these genes 

around. And when you use an antibiotic, you select for those resistant ones, those that have picked up these resistance genes, to proliferate, and they grow and they multiply. 

And bacteria multiply. I mean, you can go from, seriously, one 

bacterium to billions in 24 hours. These are fast growing bacteria. 

132 

And so wherever you are using antibiotics, you are selecting for 

these drug-resistant bacteria, whether it be in a hospital or on a 

farm where you have thousands of animals crammed together and, 

you know, among each others’ feces and sharing bacteria constantly. And so when you add in these antibiotics, that is the magic 

ingredient for creating drug-resistant pathogens. 

And then when you butcher those animals, you almost inevitably 

contaminate the carcass with the bacteria from those animals, and 

now you have meat products that are contaminated with drug-resistant bacteria that then are distributed to every grocery store in 

the country. And the NARMS reports tell us that the drug-resistant bacteria are there, that our food supply is riddled with drugresistant bacteria. 

And then there are the food animal producers, the people working in the industry that can pick up these resistant bacteria, bring 

them to their homes, bring them into our hospitals. 

Mr. PALLONE. And then what is the harm to humans at that 

point? Because now they become resistant as well? What is the 

harm to humans? 

Dr. PRICE. So the harm to humans is that we get infected with 

these drug-resistant bacteria, and the best defense against a bacterial infection is an antibiotic. So if you go into a doctor with a 

bacterial infection, they are going to try to treat you with an antibiotic, but if that bacteria is resistant to antibiotics, you could die 

of that infection, that treatment is going to fail. 

And so every time we use antibiotics, every drug that we waste 

for nontherapeutic purposes in food animal production is creating 

resistance to those drugs, so those are taken off the shelf for therapy. So the physician has to reach higher and higher on that shelf 

for those last drugs. 

Mr. PALLONE. And what you are saying is that the very nature 

of farm production with this bacteria causes that environment 

where the resistant bacteria thrive, essentially? 

Dr. PRICE. Exactly. So when I look at a modern food animal production setting, I see the perfect setting for disease proliferation, 

for bacteria to spread among animal hosts, right. So we know if we 

cram people together in unsanitary conditions, they are going to 

spread bacteria among one another. And then we add the magic ingredient, which is antibiotics, which is going to force those bacteria 

to become resistant to those antibiotics. You know, people call 

these factory farms, but I don’t see factories making meat, I see 

factories making drug-resistant bacteria. 

Mr. PALLONE. All right. Thank you very much. 

Mr. PITTS. The chair thanks the gentlemen. Now recognize the 

gentleman from Illinois, Mr. Shimkus, 5 minutes for questions. 

Mr. SHIMKUS. Thank you, Mr. Chairman. 

And, Dr. Carnevale, you have heard Dr. Price and some of his 

answers. Can you explain to us why there are logistical difficulties 

and expenses for your members in reporting sales by animal species, dose, intent of use, and for the growth promotion, disease control, or treatment? 

Dr. CARNEVALE. Yes. Well, as you know, since 2008, our companies have been providing sales data. Sales data is not an indicator 

of use. The problem with our companies trying to refine exactly 

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how those products are being used in the field is because when our 

companies sell their product, particularly feed use products, they 

will sell them to a distributor, to a veterinarian, to other sources. 

They may get used at that level or they may be sold to other distributors. 

So once the product is out in the field and being used our companies don’t know what the product was sold for, because many of 

these products have multiple species on the label and multiple indications. So they are frequently fairly long labels for many of these 

products. And once the product is sold in the marketplace our companies simply don’t know exactly what species it has been used in 

or what is the purpose it was used for. 

Mr. SHIMKUS. Thank you. 

Dr. Apley, what is the relationship, if any, between the most serious human antibiotic-resistant concerns and antibiotic use and resistance in food animals? 

Dr. APLEY. I think that relationship is discussed on the basis of 

specific organisms of concern. One of the things I want to make 

clear is that I think engaging in this conversation is critical and 

support that. I think if we start to assume that all resistance is 

due to this, we go down a road where we are going to end up with 

consequences that aren’t appropriate. If you look at organisms such 

as salmonella, it is quite appropriate to have these discussions. 

There are others for which I think the evidence is much less apparent, at least in my evaluation of it. 

Mr. SHIMKUS. So, I mean, you mean consequences that are not 

appropriate. What do you mean by that statement? 

Dr. APLEY. We do good in animals with antibiotics when we 

apply them judiciously. We can have benefits for their health. And, 

you know, we talk about in the environments they are in. Well, if 

you take modern swine production, you know, you shower in, you 

shower out. They take a group of animals completely out, it is 

steam cleaned, it is sanitized, they come back in, and still—— 

Mr. SHIMKUS. So versus this walking around in each others’ feces 

and—— 

Dr. APLEY. At times during the production period, like with a 

slatted floor, they will have some there, they track it through, so 

there is some present, but it isn’t like they are wallowing in a cesspool. It is designed so that it is tracked through, goes into a pit and 

then is removed. 

Mr. SHIMKUS. And you have operated major feed operations, or 

you have observed all this process—— 

Dr. APLEY. Yes. 

Mr. SHIMKUS [continuing]. In the field? 

Dr. APLEY. Yes. But we do have beneficial effects on creating 

healthy animals. And I am a believer that healthy animals create 

healthy food. 

Mr. SHIMKUS. And that was my follow-up, too. It would be better 

to have a healthy animal that goes through the food process than 

an unhealthy animal for human consumption? 

Dr. APLEY. Correct. And I want to emphasize that our goal in the 

food animal industries is to prevent disease. Sometimes we get the 

impression that we are throwing these things around and just flying them in. They are an expense to us, and when we have to use 

134 

them, we have an animal that is ill or on the verge of being ill, and 

it is in everyone’s best interest, the animal, the producer, the consumer, that we do everything we can, vaccines, animal flow, to 

produce that. So it is important we realize that we don’t use antibiotics because we are lazy and don’t want to try to prevent disease, we use them as a tool. 

Mr. SHIMKUS. Let’s follow up on the collection of data and the responses that you have heard here. Will use data provide us the information we need to understand the epidemiology or the risk of 

antibiotic resistance? It is hard for me to say; easy for you all. 

Dr. APLEY. I think we have to carefully define between use date 

and sales data. There is a recent paper by Jensen that was conducted in Denmark, in the Netherlands, that showed very clearly 

that sales data does not correlate well with use data. 

And then the other important thing we ask is how are we going 

to use these data. It is very important that when we have these 

data we actually apply them to something that is related. If we collect use data over here and have resistance data over here and 

marry them together, we will get lines on a graph which we may 

try to interpret, but they may be, in fact, not be related. 

I am not saying we shouldn’t look, but we need to put very careful thought into how we are going to collect and interpret the data 

first. 

Mr. SHIMKUS. Thank you very much. 

Thank you, Mr. Chairman. 

Mr. PITTS. The chair thanks the gentlemen. And now recognize 

the ranking member of the full committee, Mr. Waxman, 5 minutes 

for questions. 

Mr. WAXMAN. Thank you very much, Mr. Chairman. 

Dr. Price, thank you very much for being here today. Some in the 

animal production industry have recognized the overwhelming scientific evidence and acknowledge that routinely giving antibiotics 

to animals in their feed or water can lead to the growth of resistant 

bugs. However, they claim there are too many steps between raising those animals on the farm and buying their meat at the grocery 

store, and that the risks of a consumer contracting an antibioticresistant pathogen from that meat is remote. 

Could you describe the steps by which the uses of antibiotics on 

the farm lead to these human illnesses? 

Dr. PRICE. Well, I think it is very clear with the classic foodborne pathogens, like salmonella, for instance, that when we use 

antibiotics in food animal production, there is a direct line. We create the drug-resistant strains of salmonella in food animals that 

then make a direct line to humans through the food supply. 

But the research that we have been doing in my lab and around 

the world now is looking beyond those classic food-borne pathogens, 

and now we are looking at the two biggest killers: we are looking 

at staph aureus and we are looking at E. coli. And every time we 

look now we are seeing more and more evidence that those bacteria, some burden of those—let me give you a case of the burden. 

Mr. WAXMAN. Well, let me interrupt you, because I only have 5 

minutes. In other words, isn’t it a mistake to say that you give an 

antibiotic to an animal for whatever reason and the consumer that 

eats the meat from that animal is not exposed? Isn’t it that by 

135 

using antibiotics for whatever purpose we are engendering the development of bacteria that are resistant to the antibiotics that we 

have now available? 

Dr. PRICE. Exactly. Whenever we use antibiotics on the farm, we 

are creating drug-resistant bacteria that could possibly cause—— 

Mr. WAXMAN. And obviously antibiotics are appropriate under 

some circumstances, but there is such a large use of antibiotics for 

animals that we don’t know if they are being used for therapeutic 

purposes or just being used to generally keep the animal healthy 

and in better commercial shape. Isn’t that what the problem is? 

Dr. PRICE. It is. 

Mr. WAXMAN. Now, Dr. Apley seemed to talk about healthy animals are better, so that means we want to keep animals healthy. 

But is there a problem in trying to keep animals healthy if they 

don’t have a disease, if we are just giving them antibiotics as a preventative for a disease? 

Dr. PRICE. I see a major problem with using antibiotics to try to 

keep animals healthy as a preventative tool. If we have created a 

food animal system that makes animals sick routinely, then we 

have created a faulty system, we need to change the system. We 

need to prevent infections other ways than using antibiotics. That 

only invites resistance. And so I will say again, I think we should 

treat sick animals, but if we see that animals are getting sick all 

the time, we should change the way we are doing it. 

Mr. WAXMAN. Now, we don’t have the data, and I have introduced a bill called the DATA Act to require industries to provide 

FDA with more detailed information on which drugs are sold and 

in what quantities for which animals and report to FDA to provide 

more detailed public reports on that information. 

Now, Dr. Carnevale said they don’t keep track of this information. Of course they can make some estimates about it. They can 

know details. But they certainly have a lot more information than 

anybody else about the use of their antibiotics. 

How would public health researchers such as yourself make use 

of this information and why is getting this information so important? 

Dr. PRICE. Well, we need to look at the relationship between antibiotic use and antibiotic resistance, especially for the newer 

drugs. You know, the emergence of cephalosporin-resistant E. colis. 

You know, ask an infectious disease doc what they would use if 

they got a cephalosporin-resistant E. coli, and many would probably tell you they would use a carbapenem. And carbapenem-resistant E. colis are the CREs, the nightmare super bugs that the CDC 

hasbeen talking about. 

So we need to understand how these antibiotics are being used, 

but also, as I said before, I think we need to be able to celebrate 

the food animal producers who are using them less. 

Mr. WAXMAN. If we don’t have every bit of information to show 

the link between the sale of an antibiotic and the use of the antibiotics, aren’t estimates important rather than just say, we don’t 

know, and therefore we don’t want to know? I mean, if we recognize, for example, that drug companies don’t have firsthand knowledge of how the drugs are actually used, if we ask them to give an 

estimate of which animals they are sold for, if they have good sales 

136 

departments, they should have at least a basis for these estimates. 

Isn’t that important and helpful information? 

Dr. PRICE. It is certainly important. And I hear people say that 

it is hard to get those data, it is so hard, it is going to be hard to 

do this. But I say what is hard is trying to treat a kid with a 

multidrug-resistant infection, watching them die of these drug-resistant infections, or trying to find new antibiotics to replace the 

ones that we have blown out through growth promotion and routine disease prevention. 

Mr. WAXMAN. And if you will permit, Mr. Chairman. And the bill 

does ask for requirements by people who use the antibiotics, so we 

can get a pretty good picture overall even if the drug companies 

don’t have detailed information about how their drug is being used 

after they sold it. But they don’t know who the customers are and 

what it is used for. Thank you. 

Dr. PRICE. That is why I am supportive of your bill. 

Mr. WAXMAN. Thank you. 

Mr. PITTS. The chair thanks the gentleman. And now recognize 

the gentlelady from North Carolina, Ms. Ellmers, 5 minutes for 

questions. 

Mrs. ELLMERS. Thank you, Mr. Chairman. 

And thank you to our panelists for being here today. 

Dr. Apley, we are talking about tools and we are talking about 

antibiotics being used by veterinarians and farmers for their livestock to keep animals healthy. What other tools are there besides 

antibiotics that can be used if we are trying to get away from the 

use of antibiotics? 

Dr. APLEY. Sure. And I mentioned pig flow strategies, for example, for the swine industry, which involves very precise control of 

where the pig is produced, where they move next, and monitoring 

disease upstream, if you will, say, in the actual pig production facility or in the farrowing facilities so that they can nip it in the bud 

before it goes further. An example in cattle is preconditioning, 

where instead of shipping them straight to the feedlot, as in the 

past, we give them an intermediate stage maybe closer to where 

they originally were, of altering weaning ages. One of the things 

we have discovered in cattle is called the Sandhills calving system, 

where we move them to fresh pastures; fence line weaning of 

calves, genetic selection. The list goes on and on, and there is a 

real, real huge focus on that type of disease prevention. 

Mrs. ELLMERS. So it is more the process of the livestock farmer 

really taking care of the animals and making changes necessary. 

I also want to ask you, and just in some of the other testimony 

and questioning that you had, to my understanding just listening 

to you, you feel that the data collection as far as antibiotic usage 

is adequate? Is that a correct assumption on my part? 

Dr. APLEY. If I could really know a few more things, I would like 

to know out of interest. I think the question becomes, how would 

we work it so that it is practical and doable? And then as a scientist, I always want to know that the data I have collected here, 

how it is confounded, what differs in how it was collected to something I am going to compare it to. 

So data estimates are good, but if we are going to make real conclusions as X is causing Y—— 

137 

Mrs. ELLMERS. Right. 

Dr. APLEY [continuing]. Then we have to be incredibly careful on 

how we interpret that. What I am waiting to hear is, as we move 

forward on methods for collecting the data, is how do we anticipate 

interpreting it and then moving from interpretation to regulatory 

or other uses. 

Mrs. ELLMERS. Perfect. Thank you. I appreciate your approach. 

I think that is very effective. 

Dr. Price, I have got some questions. I was just going over some 

of your testimony here. You are critical, I think that is an accurate 

assessment, of the FDA on the use of antibiotics and the treatment 

of use of antibiotics. And one of the quotes that I am just going to 

point out here, it says, the FDA, I am paraphrasing there, negotiated an agreement to collect fees from drug makers in exchange 

for expediting drug approval, while missing a prime opportunity to 

seek some commonsense provisions to simply measure, not restrict, 

just measure the use of antibiotics. 

But in all honesty, isn’t that really what you are looking for? I 

mean, you really are looking to restrict. And you have pointed out 

a number of situations. And, look, I am a nurse, I totally understand the idea and concept, and I think we are all well aware of 

overuse of antibiotics, but I am not necessarily sure that the farming community is where we need be focusing and not on just the 

over-prescription made on antibiotics, you know, out there in the 

medical world. 

You named a few forms of bacteria—staph aureus, MRSA—you 

also mentioned cephalosporin-resistant E. coli. Now, E. coli I know 

are being found on farms, obviously. But are those found on farms? 

Are these particular bacteria strains there and something that we 

should be issuing? 

And I would further that, and we have only got 30 seconds, so 

I apologize, my time will be running out, but we do cook food, I 

mean, and so the assumption that food is being eaten that is, you 

know, filled with bacteria, it does get cooked. So I would like you 

to comment on that as well. 

Dr. PRICE. OK. I will go quickly. We see the same E. coli that 

cause urinary tract infections, kidney infections, blood infections on 

the farm, we see them in the animals, we see them in the meat. 

We see staph aureus, we see multidrug-resistant staph aureus, and 

we see MRSA on the farms. And there is a difference on the farms 

that use antibiotics and those that don’t. We see more antibiotics 

on the conventional farms than those antibiotic-free farms. That is 

very clear. 

You said we should cook the meat. It is true. We should cook the 

meat. I don’t want anybody to think we shouldn’t. But do you cook 

chicken? When you open that package, you know that liquid that 

is in there? Think about drug-resistant bacteria on your hands. So 

you open that up. Now your hands are contaminated. But we have 

spoken, so you are going to be really careful. And you are going to 

put that chicken right in the hot frying oil, right? And then you are 

going to take that package and you are going to open up the cabinet and you are going to throw it away. You have just contaminated your cabinet. You are going to go wash your hands. You are 

going to contaminate your faucet, you are going to pump the soap 

138 

and contaminate that. And you are going wash your hands and you 

are going to sing ‘‘happy birthday’’ and get them really clean, and 

you are going to rinse them off and you are going to recontaminate 

and you are going to make a salad, and that salad can get drugresistant bacteria in it. And that is how those things can spread. 

And you still have them on your cutting board, on your countertop. 

These things spread around. We don’t think it is that people are 

eating chicken sushi. That is gross, right? It is cross-contamination 

and that happens. 

Mrs. ELLMERS. OK. And I appreciate that. And I realize I have 

run out of time, so I appreciate the indulgence. But I would say 

there again, it is an issue of process and efficiency. So thank you. 

Mr. PITTS. The chair thanks the gentlelady. And now recognize 

the gentlelady from Virgin Islands, Dr. Christensen, 5 minutes for 

questions. 

Mrs. CHRISTENSEN. Thank you, Mr. Chairman. And good afternoon to the panel. 

Dr. Price, it is nice to welcome a fellow Colonial here today. And 

my first question, you may have already answered, because the 

first question I had was, is there more that the FDA and industry 

should be doing to address the problem of antibiotic resistance 

stemming from the use of these drugs on the farm? And you have 

about four or five recommendations regarding reporting and data. 

Is there anything further that you would add? 

Dr. PRICE. Well, I just want to emphasize that prudent use goes 

beyond just growth promotion. So that is, as I said, the most egregious use. But I think routine disease prevention. So I am not talking about, you know, for a short period of time you see that there 

is a problem and you have to use preventative antibiotics, but I am 

saying when you time it for a flock cycle or a herd cycle and you 

are going to say every time we are going to give antibiotics at this 

time, that is a problem and that is going to select for drug-resistant 

bacteria, and it does select for drug-resistant bacteria, and we have 

to get past that. You know, control I am OK with, therapy I am 

definitely OK with, but this routine disease prevention is, I think, 

insane. 

Mrs. CHRISTENSEN. I am sure you are just passionate about the 

overuse of antibiotics in human beings. 

Dr. PRICE. I am. I am. And they work hand in hand, and I wanted to say that earlier. It is not just antibiotic use in food animal 

production. I don’t want anybody to walk away from here thinking 

that. You know, we have abused antibiotics in the hospitals and we 

have abused them on the farms. And the thing is, as I think about 

this environmental health paradigm where they say, with cancer, 

they say, you know, the genes load the gun and the environment 

pulls the trigger. So you are born with this propensity for cancer 

and then you get exposed to a carcinogen, and that can pull the 

trigger. But I think about the food loading the gun. So you are ingesting drug-resistant bacteria that is loading your system. 

Most of us probably have some of these drug-resistant bacteria 

in our guts. Most of the time it is no problem. But then we get sick, 

we go into the hospital, we get treated with antibiotics, and then 

those bacteria have a selective advantage, and they proliferate and 

139 

they get disseminated, and then they get disseminated into the 

hospital. 

Mrs. CHRISTENSEN. Thank you. And I had asked Dr. Dunham a 

question I wanted to ask you also. As we finalize the guidance that 

recommends the phasing out of animal production uses like growth 

promotion and feed efficiency, do you think it is possible for industry to essentially switch a growth promotion claim to a disease prevention claim with just some data showing that the same dose of 

a drug that promotes growth would also prevent disease? 

Dr. PRICE. I am very concerned about this. I am very concerned 

that if we don’t collect very detailed data, that if we don’t get the 

data that I am asking for, that Congressman Waxman’s bill would 

collect, that people are just going to change what they are doing. 

We need to be collecting data on how much are being used so we 

can see hopefully that they come down. But if they just switch the 

names of it, the bacteria don’t care. The bacteria don’t think about 

names of antibiotic use. 

Mrs. CHRISTENSEN. Thank you. I yield back the balance of my 

time. Thank you. 

Mr. PITTS. The chair thanks the gentlelady. And now recognize 

the gentlemen from Colorado, Mr. Gardner, 5 minutes for questions. 

Mr. GARDNER. Thank you, Mr. Chairman. And thank you to the 

witnesses today for joining this hearing. 

And, Dr. Price, you mentioned factory farmers earlier. What is 

your definition of a factory farm? 

Dr. PRICE. Well, as I said, other people use this term. I rarely 

use that term. I think when I see these farms, I see factories making drug-resistant bacteria. I see an industry—— 

Mr. GARDNER. Just to be clear—— 

Mr. PRICE [continuing]. That is breaking all the rules. 

Mr. GARDNER. Just to be clear, you are not talking about a feedlot in and of itself being a factory farm? 

Dr. PRICE. No. I am talking about any kind of CAFO where you 

have animals packed together that are part of an industrial system 

where you are bringing the animals all in, you are cramming them 

together, and you are feeding them feed that is laced with antibiotics. 

Mr. GARDNER. And I want to be very clear here. I am not trying 

to put words in your mouth. 

Dr. PRICE. Please. 

Mr. GARDNER. You don’t like feedlots? 

Dr. PRICE. I don’t like putting thousands of animals together 

under unsanitary conditions and giving them antibiotics. I do not 

like this. 

Mr. GARDNER. OK. So just the way we keep feedlots, you don’t 

like that? 

Dr. PRICE. I do not like situations where we feed animals 

crammed together antibiotics, because I know what it does. It creates antibiotic-resistant bacteria. 

Mr. GARDNER. Right. 

Dr. PRICE. My family owns a cattle ranch in Texas. I was raised 

working work on a cattle ranch. I am not against meat production. 

140 

There is not a person in this room that loves a hamburger more 

than me, I can tell you that. 

Mr. GARDNER. Thank you. 

Dr. Apley, it is not often that I get somebody from Kansas before 

this committee, so I thought we would spend the rest of the time 

talking about water. Just kidding, just kidding. 

Dr. Apley, as a veterinarian you are obviously trained in a different way than a doctor is in how to assess—than an M.D., a medical doctor that treats humans, is trained to communicate with 

something that can’t talk back to you to tell you where it hurts, 

to tell you what is wrong. And because of that you have a different 

relationship with the people that you see, the herd that you oversee, your—the people, the ranchers that you are dealing with. 

Can you tell me a little bit about how you interact with the people who are managing a herd, because you have a relationship with 

them, right? It is not just, you know, distributing a drug, here it 

is, and you don’t see them again, and they walk away, and they 

are gone. 

Dr. APLEY. Well, probably the best way to describe a day, show 

up, look at the records, see the manager, and then the rest of my 

day was spent with the people that took care of the animals. The 

hardest thing as a veterinarian is to just stand back and not do, 

but to watch and observe. So we observed what they were doing, 

and we used protocols and standard operating procedures as the 

basis for our training. 

Mr. GARDNER. And what would happen—if we talked about some 

of the preventative efforts to make sure that our herds are healthy, 

what would happen? What would the economic impact be on our 

food supply if we did not prevent disease in our herds? 

Dr. APLEY. Well, it would be dramatic and catastrophic if we 

weren’t able to prevent disease, and that goes back to all the different ways we are summing together to try to prevent that disease. 

Mr. GARDNER. Would it impact the supply available to consumers 

around the world? 

Dr. APLEY. It would definitely have a negative impact on what 

we are able to produce, yes. 

Mr. GARDNER. Could you talk a little bit about some of the—and 

you mentioned it before, but go over again some of the key points 

of public and animal health safeguards that are in place from a 

regulatory standpoint and industry standpoint. 

Dr. APLEY. Well, for example, in feed use we are not able to use 

that off label at all. That is strictly by the label. For injectable 

uses, uses we can use on individual animals like that, there is the 

ability to use that off label, but only under very strict Animal Medicinal Drug Use Clarification Act regulations, which require veterinarians involved, has a valid rationale, assigns an extended 

withdrawal period to make sure the animals are properly identified. 

Mr. GARDNER. And is there anything the FDA could be doing 

more to establish appropriate guidelines, regulations regarding the 

administration of animal drugs? 

Dr. APLEY. I think one of the biggest things, and Dr. Dunham 

mentioned this, is there are listening sessions out there as we look 

141 

at moving towards all of the feed and water uses being under veterinary control, that we come up with a system with limited veterinary availability in some areas that makes that workable for all 

parties. We appreciate them have those listening sessions, and I 

think right now that is one our biggest goals to get that done correctly. 

Mr. GARDNER. Thank you. And just appreciate your work with us 

today and look forward to working with you through the process. 

Yield back my time. 

Mr. PITTS. The chair thanks the gentlemen. 

We have a UC request. 

Mr. PALLONE. Mr. Chairman, I would ask on behalf of Mr. Waxman unanimous consent to enter into the record some letters that 

were sent to him and you with regard to the DATA Act. 

Mr. PITTS. Without objection, so ordered. 

[The information appears at the conclusion of the hearing.] 

Mr. PITTS. I want to thank the witnesses for your testimony. It 

has been a very important hearing; excellent, excellent testimony. 

Members may have questions that they will send to you. I remind 

Members they have 10 business days to submit additional questions for the record, and I ask the witnesses to respond to the questions promptly. And Members should submit their questions by the 

close of business on Tuesday, April 23rd. 

Without objection, the subcommittee is adjourned. 

[Whereupon, at 6:05 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

142 


80810.032

Center for Science in the Public Interest· Food Animal Concerns Trust· Health Care Without Harm 

Keep Antibiotics Working· Natural Resources Defense Council· Union of Concerned Scientists 

April 5, 2013 

The Honorable Fred Upton 

Chairman 

Committee on Energy and Commerce 

U.S. House of Representatives 

2125 Rayburn Building 

Washington, DC 20515 

The Honorable Joe Pitts 

Chairman, Subcommittee on Health 

Committee on Energy and Commerce 

U.S. House of Representatives 

2125 Rayburn Building 

Washington, DC 20515 

The Honorable Henry Waxman 

Ranking Member 

Committee on Energy and Commerce 

U.S. House of Representatives 

2322A Rayburn Building 

Washington, D.C. 20515 

The Honorable Frank Pallone 

Ranking Member, Subcommittee on Health 

Committee on Energy and Commerce 

U.S. House of Representatives 

2322A Rayburn Building 

Washington, D.C. 20515 

Re: Public Health Enhancements to the Animal Drug User Fee Act 

Dear Chairmen Upton and Pitts and Ranking Members Waxman and Pallone: 

We write on behalf of a broad coalition of medical, public health, scientific, consumer, and environmental 

organizations, to urge that the reauthorization of the Animal Drug User Fee Act (ADUFA) include 

provisions to help preserve the efficacy of antibiotics vital to protecting public health. Specifically, we 

urge you to enact the data collection and reporting requirements in the Delivering Antimicrobial 

Transparency in Animals (DATA) Act (H.R. 820), introduced by Representatives Waxman and Louise 

Slaughter, as part of the Animal Drug User Fee Act (ADUFA). 

Antibiotics, the miracle drugs of the last century, are losing their effectiveness as a result of misuse and 

overuse in human medicine and food animal production. We must continue to pursue efforts to address 

resistance related to human use of antibiotics, but antibiotic use in animal agriculture constitutes the 

overwhelming majority of antibiotic use (accounting for over 70% of total sales of medically important 

antibiotics in the United States) and must also be addressed. A focus on human use alone cannot address 

the problem. 

Antibiotic resistance is an expensive and critical public health threat - one ofthe Centers for Disease 

Control and Prevention's "top concerns." Each year an estimated 900,000 cases of antibiotic-resistant 

infection cost society up to $26 billion in additional healthcare costs, and lead to tens of thousands of 

deaths as well. The Director General ofthe World Health Organization has warned that we face a "postantibiotic era ... in effect, an end to modem medicine as we know it" and that "'[tjhings as common as 

strep throat or a child's scratched knee could once again kill." 
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As the CDC and others note, strong science - more than 147 studies to date -links antibiotic use in 

animals to antibiotic resistance and risks to human health. Leading medical, public health, and scientific 

organizations have called for an end to the unnecessary use of antibiotics in animals that are not sick-a 

key contributor to the rising tide of antibiotic resistance-and for better tracking and reporting of data on 

antibiotic sales and use to address the threat. 

We need action to curb the overuse of antibiotics in food producing animals. We also need the Food and 

Drug Administration (FDA) to better track and publicly report data that can be used to track trends in 

antibiotic resistance, design appropriate interventions, and fine-tune those efforts if they have not been 

effective. 

In 2008, Congress through ADUF A reauthorization required drug manufacturers to report antimicrobial 

sales to FDA and directed FDA to release a summary of these data to the public. The FDA's Summary 

Reports for 2009,2010 and 2011 report only total antimicrobial sales volumes by drug class, aggregated 

to the national level, without any information on animal species in which antibiotics are used or the nature 

and purpose of their use. Scientists need this data to better understand geographic and temporal trends in 

antibiotic resistance. Unfortunately, standalone summary sales data, without more detail, are insufficient 

to track these trends and develop appropriate interventions. To effectively control the antibiotic 

resistance epidemic, both governmental and non-governmental animal health and infectious disease 

experts need ongoing access to reliable data on the scope of antibiotic consumption in animals, by 

species, and in a unit of measure that can be compared across species and localities. 

Therefore, during the current reauthorization, we ask the committee to enhance ADUF A further with the 

DATA Act's provisions to: 

• Require large-scale live poultry dealers, swine contractors, and feed lot operators to 

report to the FDA information on the amount of antibiotics used by animal species and 

require drug sponsors to report antibiotic sales broken down by animal species 

Require FDA to include in its public summaries information on amounts of antibiotics 

sold (including for feed sold pursuant to a Veterinary Feed Directive) 

o by different dosage forms (i.e. in feed, in water, or by injection), 

o by different marketing status (e.g. over-the-counter or prescription), 

o by percentages sold for different approved purposes (i.e. growth promotion, 

disease prevention, disease control, and treatment), 

o by differing medical importance, and 

o by each food-producing animal species 

• Require FDA to include in its public summaries information on quantities of antibiotic 

sold and distributed by state. 

Again, we urge you to support stronger data collection and reporting for agricultural antibiotic sales and 

distribution by amending ADUF A to include these requirements. These provisions will help scientists 

better understand and track current use patterns, explain resistance trends, and monitor progress in 

reducing antibiotic use and resistance. This information can help ensure that these essential medicines 

continue to be effective and to protect children and families well into the future. 
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Thank you for considering our views. 

Sincerely, 

Center for Science in the Public Interest 

Food Animal Concerns Trust 

Health Care Without Hann 

Keep Antibiotics Working 

Natural Resources Defense Council 

Union of Concerned Scientists 
145 


80810.035

April 5, 2013 

The Honorable Fred Upton 

Chainnan 

Committee on Energy and Commerce 

U.S. House of Representatives 

2125 Rayburn Building 

Washington, DC 20515 

The Honorable Joe Pitts 

Chainnan, Subcommittee on Health 

Committee on Energy and Commerce 

U.S. House of Representatives 

2125 Rayburn Building 

Washington, DC 20515 

The Honorable Henry Waxman 

Ranking Member 

Committee on Energy and Commerce 

U.S. House of Representatives 

2322A Rayburn Building 

Washington, D.C. 20515 

The Honorable Frank Pallone 

Ranking Member, Subcommittee on Health 

Committee on Energy and Commerce 

U.S. House of Representatives 

2322A Rayburn Building 

Washin!:,rton, D.C. 20515 

Dear Chainnen Upton and Pitts and Ranking Members Waxman and Pallone: 

On behalf of the undersigned organizations representing medical, public health, scientific, 

agricultural, environmental, animal protection, and other organizations, we urge you to include 

H.R. 820, the Delivering Antimicrobial Transparency in Animals (DATA) Act, as part of the 

final Animal Drug User Fee Act (ADUFA). This legislation provides a reasonable, commonsense approach to better understanding antibiotic use in agriculture. 

There is substantial scientific evidence supporting the claim that non-judicious use of 

antimicrobials in both humans and food animals leads to development of antimicrobial resistance 

in human pathogens. Given the increasing proportion of highly-resistant pathogens that are 

causing human disease today, improved antimicrobial stewardship will have a significant 

positive impact on human health. Unless we are able to significantly change the way we use 

antimicrobials in both clinical medicine and in agriculture, we risk entering a "post-antibiotic" 

era, where people die of common infections that previously had been treatable. 

The DATA Act would provide the Food and Drug Administration (FDA) and the public with 

better infonnation on the use of antimicrobial drugs in food animals. Such data will enable 

public health officials and scientists to better understand and interpret trends and variations in 

antimicrobial resistance, to improve the understanding of the relationship between animal uses of 

these drugs and antimicrobial resistance in animals and humans, and to identiJY interventions to 

prevent and control resistance. 

FDA's current data collection efforts are insufficient to detect correlations between antibiotic 

use and the development of resistance. 

The Animal Drug User Fee Act of2008 (ADUFA) authorized FDA to collect and publish data 

from phannaceutical companies on antibiotics sold for use in food animals, but unfortunately it 

stops short of requiring public reporting of critical details that would be needed to effectively 

interpret trends in resistance. ADUF A requires drug sponsors to report to the FDA basic 
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PAGE TWO-DATA Act: 15 Organization Support Letter 

information about their antimicrobial products, including I) the amount of each antimicrobial 

active ingredient by container size, strength, and dosage form; 2) quantities distributed 

domestically and outside the United States; and 3) dosage form, including a listing of the target 

animals, indications, and approved production classes. Despite being collected by the FDA, data 

publicly reported under ADUFA have been substantially limited. The Summary Reports for 

2009, 20 I 0 and 20 II report only total antimicrobial sales volumes by drug class, aggregated to 

the national level, without any information on animal species in which antibiotics are used or the 

purpose of their use. Unfortunately, standalone summary sales data, without additional 

granularity, is insufficient to effectively study and understand the relationship between antibiotic 

use and the development of resistance and to consider appropriate interventions. 

In September 201 I, the Government Accountability Office (GAO) published a report titled 

Antibiotic Resistance: Agencies Have Made Limited Progress Addressing Antibiotic Use in 

AnimaZ/, which highlighted shortcomings in the current FDA regulations on antimicrobial 

animal drug sales and distribution reporting. Indeed, the current lack of adequate U.S. antibiotic 

consumption data impedes our understanding of geographic and temporal trends in antibiotic 

resistance. In the agricultural context, a more complete and accurate dataset on antibiotic 

consumption will make information currently collected under the National Antimicrobial 

Resistance Monitoring System (NARMS) more effective, because it could be used to show 

possible correlations between antibiotic use and the development of resistance. 

The DATA Act will ensure that U.S. experts have access to reliable, standardized data on the 

scope of antibiotic consumption in animals by species. 

To effectively control the antibiotic resistance epidemic, both governmental and nongovernmental animal health and infectious disease experts need ongoing access to reliable data 

on the scope of antibiotic consumption in animals, by species, and in a unit of measure that can 

be compared across species and localities. The DATA Act accomplishes this goal by requiring: 

• drug sponsors to include in their annual FDA reports the dosage fonn and the known or estimated 

amounts of the antimicrobial ingredients in new animal drugs sold or distributed for use in each 

food-producing animal species for which the new animal drug is approved. 

large-scale live poultry dealers, swine contractors, and feed lot operators to submit annual reports 

to FDA on the antimicrobials used in their animal feed. For antimicrobials in feed under a 

Veterinary Feed Directive (VFD), the reports would be required to include infonnation on 

quantities, dosages, and duration oftime that the feed may have been provided to the animals. 

• FDA to report data on the percentage of antimicrobials sold for growth promotion/feed efficiency, 

disease prevention, disease control, and disease treatment. 

I U.S. Government Accountability Office, Agencies Have Made Limited Progress Addressing Antibiotic Use in 

Animals, GAO-I 1-801, September 7, 201 l. 
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PAGE THREE-DATA Act: 15 Organization Support Letter 

• FDA to provide the quantity of drugs sold or distributed state-by-state, as well as the quantity of 

drugs sold or distributed for each type of animal. 

• for feed sold pursuant to a VFD, FDA to provide data on the indication for which the feed was 

sold or distributed, the quantities of feed sold or distributed for each such indication, the number 

of individual animals to which the feed was intended to be given, and the dosage and length of 

time for which such feed was intended to be given. 

Again, we urge you to support stronger reporting requirements for agricultural antibiotic sales 

and distribution by amending ADUF A to include the DATA Act. This important legislation will 

help illustrate current use patterns, explain resistance trends, and monitor progress in assuring 

responsible animal antibiotic use. The American public needs assurance that these essential 

medicines will be effective in protecting children and families well into the future. Should you 

have any questions, please contact Amanda Jezek at 703-740-4790 or ajezek(a)idsociety.org. 

Signed, 

Alliance for the Prudent Use of Antibiotics 

American Academy of Pediatrics 

American Public Health Association 

Association for Politics and the Life Sciences 

Food & Water Watch 

Humane Society Veterinary Medical Association 

Infectious Diseases Society of America 

Institute for Agriculture and Trade Policy 

Johns Hopkins Center for a Livable Future 

Pediatric Infectious Diseases Society 

School Food FOCUS National Office 

Society of Infectious Diseases Pharmacists 

The Humane Society of the United States 

Trust for America's Health 

The Pew Charitable Trusts 

cc: Members ofthe Committee on Energy and Commerce 

Rep. Louise Slaughter 
148 


80810.038

April 2, 2013 

The Honorable Henry A. Waxman, Ranking Member 

Energy and Commerce Committee 

U.S. House of Representatives 

2204 Raybum 

Washington, DC 20515 

Dear Ranking Member Waxman, 

The Patient, Consumer, and Public Health Coalition strongly supports H.R. 820, the 

Delivering Antimicrobial Transparency in Animals (DATA) Act. Thank you for 

introducing this legislation, which would enhance the reporting requirements for 

antimicrobial drugs used in food animals. 

The growing risk of drug-resistant bacteria infections will only be solved by responsible 

use of currently available therapeutics. With approximately 80% of antibiotics sold in the 

United States being used in food animals, we need to better understand how antibiotic use 

in food animals is contributing to the increase in drug resistant microbes that affect both 

animals and humans. 

The DATA Act would make it easier for public health officials to track how antibiotics 

administered to food animals contribute to the development of microbial resistance to 

specific drugs. It would also provide much needed information for drug manufacturers, 

food-animal producers, and medical providers to design adequate strategies for 

responsibly using antibiotics. 

H.R. 820 would standardize reporting of how antibiotics are used in food animals and 

require this information to be distributed in a timely manner. The Act would foster 
149 


80810.039

interagency efforts at the Food and Drug Administration and the Department of 

Agriculture in tackling the growing problem of antibiotic resistance. The FDA's Draft 

Guidance 213 should help in reducing antibiotic use, and the DATA Act requires that the 

Final Guidance be published no later than six months after the enactment of the Act. 

Reporting requirements in H.R. 820 would still permit poultry dealers, swine contractors, 

and feed lot operators to maintain healthy animals. At the same time, your bill would 

help to ensure that antibiotics continue to be life-saving therapeutics for humans, 

companion animals, and all other animals. We thank you for your leadership in 

addressing this growing public health problem. 

Annie Appleseed Project 

Connecticut Center for Patient Safety 

Consumers Union 

Jacobs Institute of Women's Health 

National Consumers League 

National Physicians Alliance 

National Research Center for Women & Families 

National Women's Health Network 

U.S. PIRG 

W oodyMatters 

For more in/ormation, contact Jennifer Yttri atjy@center4research.orgor Paul Brown 

at pb@center4research.org or (202) 223-4000. 
150 


80810.105

The Honorable Joseph R. Pitts 

Chairman 

Subcommittee on Health 

Committee on and Commerce 

IIouse of Representatives 

Washington, D.C. 20515-6115 

Dear l\1L Chail1uan: 

24 

Thank you for providing the Food and Drug Administration (FDA or the Agency) with 

the opportunity to testify at the April 9, 2013, hearing emilled "Reauthorization of 

Animal Drug User Fees: ADUFA and AUDUFA." This letter provides the response to 

Representative Frank Pallone's request at the hearing for infmmation about when a 

proposed rule entitled "Electronic Distribution of Prescribing Inlbl1nation for Human 

Drugs Including Biological Products" >vill be issued. The eurrent Unified Agenda notes 

that the Food and Drug Arullini1'tration '5 (FD/\ or t.he Agency) targd date jor issuing the 

proposed rule is June 2013. Mr. Pallone also asked for an update on the process moving 

forward. 

While we can not provide a specific timeline or details ofthe proposed rule's contents 

prior to the issuance of the proposed rule, lhis is an issue of importance, and FDA 

continues to move fbnvard on this proposed rule. Once the proposed rule is published, 

there will be a public comment period, during which lime all intercsted stakeholders and 

the public will have the opportunity to provide FDA with their views on the substance of 

the proposed rule. Public comments are carefully reviewed by FDA and taken into 

account when drafting a final rule. 

FDA agrees that electronic distJ'ibution of pHJfessional prescribing information will allow 

for more rapid distribution to health care professionals of the most up-tn-date infnnnation 

about a prescription drug, including new warnings, contraindications, and directions for 

use, ,vhich would contribute to better care for patients, reduction in medication crrors, 

and improved public health. Currently, the professional prescribing intbl1nation 

containing the information for the safe and effective use of the product is distributed in 

the fOl1n of paper leaflets. Although the infol1nation in the professional prescribing 

infol111ation is a valuable resource, it may not contain the most current information 

because the paper leaflets accompanying a drug during distribution may have been 

printed and distributed prior to more recent labeling changcs. The most common reasons 

for the printed professional prescribing information that is in the package on pharmacy 

shelves to be out of date are changes related 10 new approved uses tor a drug already on 
151 

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80810.106

Page 2 The Honorable Joseph R. Pitts 

the market and new safety infhrmation detected from post-market use of the drug or from 

ongoing clinical trials. 

FDA seeks to establish a modem and el1icient proeess to distribute professional 

prescribing infi:lnl1ation to health carc professionals, Because it takes lime 10 prepare 

revised paper professional prescribing info1111ation, include it in the drug packages, and 

get those packages into distribution, the electronic distribution of proiessional prescribing 

infbnnation would help ensure that health care professionals have more rapid access to 

the most up-to-date information about the safety ofmarketed drugs, 

Please let us know if you have any further questions, 

cc: The Honorable Frank Pallone, Jr. 

Ranking .Member 

Subcommittee on Health 

Sincerely. 

I'vlichele Mital 

Acting Associate Commissioner 

for Legislation 

Committee on Energy and Commerce