I 

113TH CONGRESS 

1ST SESSION H. R. 1407 

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

fee programs relating to new animal drugs. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 9, 2013 

Mr. SHIMKUS (for himself, Mr. GARDNER, Mr. UPTON, Mr. PITTS, Mr. WAXMAN, Mr. PALLONE, Mr. BURGESS, Mr. GUTHRIE, and Mr. KINZINGER

of Illinois) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

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

reauthorize user fee programs relating to new animal drugs. 

1 Be it enacted by the Senate and House of Representa2 tives 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 ‘‘Animal Drug User Fee Amendments of 2013’’. 

6 (b) FINDING.—Congress finds that the fees author7 ized by the amendments made in this Act will be dedicated 

8 toward expediting the animal drug development process 

9 and the review of new and supplemental animal drug apVerDate Mar 15 2010 02:35 Apr 11, 2013 Jkt 029200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1407.IH H1407

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1 plications and investigational animal drug submissions as 

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

3 of subchapter C of chapter VII 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–11) is amended to read as follows: 

13 ‘‘SEC. 739. DEFINITIONS. 

14 ‘‘For purposes of this part: 

15 ‘‘(1) The term ‘animal drug application’ means 

16 an application for 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’ means— 

23 ‘‘(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 approve 

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 ingredient 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’ means— 

22 ‘‘(A) the filing of a claim for an investiga23 tional exemption under section 512(j) for a new 

24 animal drug intended to be the subject of an 


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1 animal drug application or a supplemental ani2 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 event of their filing. 

8 ‘‘(6) The term ‘animal drug sponsor’ means ei9 ther an applicant named in an animal drug applica10 tion that has not been withdrawn by the applicant 

11 and for which approval has not been withdrawn by 

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

14 been terminated or otherwise 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 includes animal drug products intended for 

21 mixing in animal feeds. 

22 ‘‘(8) The term ‘process for the review of animal 

23 drug applications’ means the following activities of 

24 the Secretary with respect to the review of animal 


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1 drug 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 which 

8 approve animal drug applications or supple9 mental animal drug applications or which set 

10 forth in detail the specific deficiencies in animal 

11 drug applications, supplemental animal drug 

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

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

16 ‘‘(C) The inspection of animal drug estab17 lishments and other facilities undertaken as 

18 part of the Secretary’s review of pending animal 

19 drug applications, supplemental animal drug 

20 applications, and investigational animal drug 

21 submissions. 

22 ‘‘(D) Monitoring of research conducted in 

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1 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) Review of advertising 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 expenses in connection with the 

19 process for the review of animal drug applications 

20 for— 

21 ‘‘(A) officers and employees of the Food 

22 and Drug Administration, contractors of the 

23 Food and Drug Administration, advisory com24 mittees consulted with respect to the review of 

25 specific animal drug applications, supplemental 


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1 animal drug applications, or investigational ani2 mal drug submissions, and costs related to such 

3 officers, employees, committees, and contrac4 tors, including costs for travel, education, and 

5 recruitment and other personnel activities; 

6 ‘‘(B) management of information and the 

7 acquisition, maintenance, and repair of com8 puter resources; 

9 ‘‘(C) leasing, maintenance, renovation, and 

10 repair of facilities and acquisition, maintenance, 

11 and repair of fixtures, furniture, scientific 

12 equipment, and other necessary materials and 

13 supplies; and 

14 ‘‘(D) collecting fees under section 740 and 

15 accounting for resources allocated for the re16 view of animal drug applications, supplemental 

17 animal drug applications, and investigational 

18 animal drug submissions. 

19 ‘‘(10) The term ‘adjustment factor’ applicable 

20 to a fiscal year refers to the formula set forth in sec21 tion 735(8) with the base or comparator month 

22 being October 2002. 

23 ‘‘(11) The term ‘person’ includes an affiliate 

24 thereof. 


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1 ‘‘(12) The term ‘affiliate’ refers to the defini2 tion set forth in section 735(11).’’. 

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

4 FEES. 

5 Section 740 of the Federal Food, Drug, and Cosmetic 

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

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

8 FEES. 

9 ‘‘(a) TYPES OF FEES.—Beginning in fiscal year 

10 2004, the Secretary shall assess and collect fees in accord11 ance with this section as follows: 

12 ‘‘(1) ANIMAL DRUG APPLICATION AND SUPPLE13 MENT FEE.— 

14 ‘‘(A) IN GENERAL.—Each person that sub15 mits, on or after September 1, 2003, an animal 

16 drug application or a supplemental animal drug 

17 application shall be subject to a fee as follows: 

18 ‘‘(i) A fee established in subsection (c) 

19 for an animal drug application, except an 

20 animal drug application described in sec21 tion 512(d)(4). 

22 ‘‘(ii) A fee established in subsection 

23 (c), in an amount that is equal to 50 per24 cent of the amount of the fee under clause 

25 (i), for— 


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1 ‘‘(I) a supplemental animal drug 

2 application for which safety or effec3 tiveness data are required; and 

4 ‘‘(II) an animal drug application 

5 described in section 512(d)(4). 

6 ‘‘(B) PAYMENT.—The fee required by sub7 paragraph (A) shall be due upon submission of 

8 the animal drug application or supplemental 

9 animal drug application. 

10 ‘‘(C) EXCEPTION FOR PREVIOUSLY FILED

11 APPLICATION OR SUPPLEMENT.—If an animal 

12 drug application or a supplemental animal drug 

13 application was submitted by a person that paid 

14 the fee for such application or supplement, was 

15 accepted for filing, and was not approved or 

16 was withdrawn (without a waiver or refund), 

17 the submission of an animal drug application or 

18 a supplemental animal drug application for the 

19 same product by the same person (or the per20 son’s licensee, assignee, or successor) shall not 

21 be subject to a fee under subparagraph (A). 

22 ‘‘(D) REFUND OF FEE IF APPLICATION RE23 FUSED FOR FILING.—The Secretary shall re24 fund 75 percent of the fee paid under subpara25 graph (B) for any animal drug application or 


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1 supplemental animal drug application which is 

2 refused for filing. 

3 ‘‘(E) REFUND OF FEE IF APPLICATION

4 WITHDRAWN.—If an animal drug application or 

5 a supplemental animal drug application is with6 drawn after the application or supplement was 

7 filed, the Secretary may refund the fee or por8 tion of the fee paid under subparagraph (B) if 

9 no substantial work was performed on the ap10 plication or supplement after the application or 

11 supplement was filed. The Secretary shall have 

12 the sole discretion to refund the fee under this 

13 paragraph. A determination by the Secretary 

14 concerning a refund under this paragraph shall 

15 not be reviewable. 

16 ‘‘(2) ANIMAL DRUG PRODUCT FEE.— 

17 ‘‘(A) IN GENERAL.—Each person— 

18 ‘‘(i) who is named as the applicant in 

19 an animal drug application or supple20 mental animal drug application for an ani21 mal drug product which has been sub22 mitted for listing under section 510; and 

23 ‘‘(ii) who, after September 1, 2003, 

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1 mal drug application or supplemental ani2 mal drug application, 

3 shall pay for each such animal drug product the 

4 annual fee established in subsection (c). 

5 ‘‘(B) PAYMENT; FEE DUE DATE.—Such fee 

6 shall be payable for the fiscal year in which the 

7 animal drug product is first submitted for list8 ing under section 510, or is submitted for re9 listing under section 510 if the animal drug 

10 product has been withdrawn from listing and 

11 relisted. After such fee is paid for that fiscal 

12 year, such fee shall be due each subsequent fis13 cal year that the product remains listed, upon 

14 the later of— 

15 ‘‘(i) the first business day after the 

16 date of enactment of an appropriations Act 

17 providing for the collection and obligation 

18 of fees for such fiscal year under this sec19 tion; or 

20 ‘‘(ii) January 31 of each year. 

21 ‘‘(C) LIMITATION.—Such fee shall be paid 

22 only once for each animal drug product for a 

23 fiscal year in which the fee is payable. 

24 ‘‘(3) ANIMAL DRUG ESTABLISHMENT FEE.— 

25 ‘‘(A) IN GENERAL.—Each person— 


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1 ‘‘(i) who owns or operates, directly or 

2 through an affiliate, an animal drug estab3 lishment; 

4 ‘‘(ii) who is named as the applicant in 

5 an animal drug application or supple6 mental animal drug application for an ani7 mal drug product which has been sub8 mitted for listing under section 510; and 

9 ‘‘(iii) who, after September 1, 2003, 

10 had pending before the Secretary an ani11 mal drug application or supplemental ani12 mal drug application, 

13 shall be assessed an annual establishment fee as 

14 established in subsection (c) for each animal 

15 drug establishment listed in its approved animal 

16 drug application as an establishment that man17 ufactures the animal drug product named in the 

18 application. 

19 ‘‘(B) PAYMENT; FEE DUE DATE.—The an20 nual establishment fee shall be assessed in each 

21 fiscal year in which the animal drug product 

22 named in the application is assessed a fee under 

23 paragraph (2) unless the animal drug establish24 ment listed in the application does not engage 

25 in the manufacture of the animal drug product 


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1 during the fiscal year. The fee under this para2 graph for a fiscal year shall be due upon the 

3 later of— 

4 ‘‘(i) the first business day after the 

5 date of enactment of an appropriations Act 

6 providing for the collection and obligation 

7 of fees for such fiscal year under this sec8 tion; or 

9 ‘‘(ii) January 31 of each year. 

10 ‘‘(C) LIMITATION.— 

11 ‘‘(i) IN GENERAL.—An establishment 

12 shall be assessed only one fee per fiscal 

13 year under this section, subject to clause 

14 (ii). 

15 ‘‘(ii) CERTAIN MANUFACTURERS.—If 

16 a single establishment manufactures both 

17 animal drug products and prescription 

18 drug products, as defined in section 

19 735(3), such establishment shall be as20 sessed both the animal drug establishment 

21 fee and the prescription drug establish22 ment fee, as set forth in section 736(a)(2), 

23 within a single fiscal year. 

24 ‘‘(4) ANIMAL DRUG SPONSOR FEE.— 

25 ‘‘(A) IN GENERAL.—Each person— 


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1 ‘‘(i) who meets the definition of an 

2 animal drug sponsor within a fiscal year; 

3 and 

4 ‘‘(ii) who, after September 1, 2003, 

5 had pending before the Secretary an ani6 mal drug application, a supplemental ani7 mal drug application, or an investigational 

8 animal drug submission, 

9 shall be assessed an annual sponsor fee as es10 tablished under subsection (c). 

11 ‘‘(B) PAYMENT; FEE DUE DATE.—The fee 

12 under this paragraph for a fiscal year shall be 

13 due upon the later of— 

14 ‘‘(i) the first business day after the 

15 date of enactment of an appropriations Act 

16 providing for the collection and obligation 

17 of fees for such fiscal year under this sec18 tion; or 

19 ‘‘(ii) January 31 of each year. 

20 ‘‘(C) LIMITATION.—Each animal drug 

21 sponsor shall pay only one such fee each fiscal 

22 year. 

23 ‘‘(b) FEE REVENUE AMOUNTS.— 

24 ‘‘(1) IN GENERAL.—Subject to subsections (c), 

25 (d), (f), and (g)— 


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1 ‘‘(A) for fiscal year 2014, the fees required 

2 under subsection (a) shall be established to gen3 erate a total revenue amount of $23,600,000; 

4 and 

5 ‘‘(B) for each of fiscal years 2015 through 

6 2018, the fees required under subsection (a) 

7 shall be established to generate a total revenue 

8 amount of $21,600,000. 

9 ‘‘(2) TYPES OF FEES.—Of the total revenue 

10 amount determined for a fiscal year under para11 graph (1)— 

12 ‘‘(A) 20 percent shall be derived from fees 

13 under subsection (a)(1) (relating to animal 

14 drug applications and supplements); 

15 ‘‘(B) 27 percent shall be derived from fees 

16 under subsection (a)(2) (relating to animal 

17 drug products); 

18 ‘‘(C) 26 percent shall be derived from fees 

19 under subsection (a)(3) (relating to animal 

20 drug establishments); and 

21 ‘‘(D) 27 percent shall be derived from fees 

22 under subsection (a)(4) (relating to animal 

23 drug sponsors). 

24 ‘‘(c) ANNUAL FEE SETTING; ADJUSTMENTS.— 


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1 ‘‘(1) ANNUAL FEE SETTING.—The Secretary 

2 shall establish, 60 days before the start of each fis3 cal year beginning after September 30, 2003, for 

4 that fiscal year, animal drug application fees, sup5 plemental animal drug application fees, animal drug 

6 sponsor fees, animal drug establishment fees, and 

7 animal drug product fees based on the revenue 

8 amounts established under subsection (b) and the 

9 adjustments provided under this subsection. 

10 ‘‘(2) INFLATION ADJUSTMENT.—For fiscal year 

11 2015 and subsequent fiscal years, the revenue 

12 amounts established in subsection (b) shall be ad13 justed by the Secretary by notice, published in the 

14 Federal Register, for a fiscal year, by an amount 

15 equal to the sum of— 

16 ‘‘(A) one; 

17 ‘‘(B) the average annual percent change in 

18 the cost, per full-time equivalent position of the 

19 Food and Drug Administration, of all personnel 

20 compensation and benefits paid with respect to 

21 such positions for the first 3 of the preceding 

22 4 fiscal years for which data are available, mul23 tiplied by the average proportion of personnel 

24 compensation and benefits costs to total Food 

25 and Drug Administration costs for the first 3 


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1 years of the preceding 4 fiscal years for which 

2 data are available; and 

3 ‘‘(C) the average annual percent change 

4 that occurred in the Consumer Price Index for 

5 urban consumers (Washington-Baltimore, DC6 MD-VA-WV; not seasonally adjusted; all items 

7 less food and energy; annual index) for the first 

8 3 years of the preceding 4 years for which data 

9 are available multiplied by the average propor10 tion of all costs other than personnel compensa11 tion and benefits costs to total Food and Drug 

12 Administration costs for the first 3 years of the 

13 preceding 4 fiscal years for which data are 

14 available. 

15 The adjustment made each fiscal year under this 

16 paragraph shall be added on a compounded basis to 

17 the sum of all adjustments made each fiscal year 

18 after fiscal year 2014 under this paragraph. 

19 ‘‘(3) WORKLOAD ADJUSTMENT.—For fiscal 

20 year 2015 and subsequent fiscal years, after the rev21 enue amounts established in subsection (b) are ad22 justed for inflation in accordance with paragraph 

23 (2), the revenue amounts shall be further adjusted 

24 for such fiscal year to reflect changes in the work25 load of the Secretary for the process for the review 


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1 of animal drug applications. With respect to such 

2 adjustment— 

3 ‘‘(A) such adjustment shall be determined 

4 by the Secretary based on a weighted average 

5 of the change in the total number of animal 

6 drug applications, supplemental animal drug 

7 applications for which data with respect to safe8 ty or effectiveness are required, manufacturing 

9 supplemental animal drug applications, inves10 tigational animal drug study submissions, and 

11 investigational animal drug protocol submis12 sions submitted to the Secretary; 

13 ‘‘(B) the Secretary shall publish in the 

14 Federal Register the fees resulting from such 

15 adjustment and the supporting methodologies; 

16 and 

17 ‘‘(C) under no circumstances shall such ad18 justment result in fee revenues for a fiscal year 

19 that are less than the fee revenues for that fis20 cal year established in subsection (b), as ad21 justed for inflation under paragraph (2). 

22 ‘‘(4) FINAL YEAR ADJUSTMENT.—For fiscal 

23 year 2018, the Secretary may, in addition to other 

24 adjustments under this subsection, further increase 

25 the fees under this section, if such an adjustment is 


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1 necessary to provide for up to 3 months of operating 

2 reserves of carryover user fees for the process for 

3 the review of animal drug applications for the first 

4 3 months of fiscal year 2019. If the Food and Drug 

5 Administration has carryover balances for the proc6 ess for the review of animal drug applications in ex7 cess of 3 months of such operating reserves, then 

8 this adjustment will not be made. If this adjustment 

9 is necessary, then the rationale for the amount of 

10 the increase shall be contained in the annual notice 

11 setting fees for fiscal year 2018. 

12 ‘‘(5) LIMIT.—The total amount of fees charged, 

13 as adjusted under this subsection, for a fiscal year 

14 may not exceed the total costs for such fiscal year 

15 for the resources allocated for the process for the re16 view of animal drug applications. 

17 ‘‘(d) FEE WAIVER OR REDUCTION.— 

18 ‘‘(1) IN GENERAL.—The Secretary shall grant a 

19 waiver from or a reduction of one or more fees as20 sessed under subsection (a) where the Secretary 

21 finds that— 

22 ‘‘(A) the assessment of the fee would 

23 present a significant barrier to innovation be24 cause of limited resources available to such per25 son or other circumstances; 


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1 ‘‘(B) the fees to be paid by such person 

2 will exceed the anticipated present and future 

3 costs incurred by the Secretary in conducting 

4 the process for the review of animal drug appli5 cations for such person; 

6 ‘‘(C) the animal drug application or sup7 plemental animal drug application is intended 

8 solely to provide for use of the animal drug 

9 in— 

10 ‘‘(i) a Type B medicated feed (as de11 fined in section 558.3(b)(3) of title 21, 

12 Code of Federal Regulations (or any suc13 cessor regulation)) intended for use in the 

14 manufacture of Type C free-choice medi15 cated feeds; or 

16 ‘‘(ii) a Type C free-choice medicated 

17 feed (as defined in section 558.3(b)(4) of 

18 title 21, Code of Federal Regulations (or 

19 any successor regulation)); 

20 ‘‘(D) the animal drug application or sup21 plemental animal drug application is intended 

22 solely to provide for a minor use or minor spe23 cies indication; or 


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1 ‘‘(E) the sponsor involved is a small busi2 ness submitting its first animal drug applica3 tion to the Secretary for review. 

4 ‘‘(2) USE OF STANDARD COSTS.—In making the 

5 finding in paragraph (1)(B), the Secretary may use 

6 standard costs. 

7 ‘‘(3) RULES FOR SMALL BUSINESSES.— 

8 ‘‘(A) DEFINITION.—In paragraph (1)(E), 

9 the term ‘small business’ means an entity that 

10 has fewer than 500 employees, including em11 ployees of affiliates. 

12 ‘‘(B) WAIVER OF APPLICATION FEE.—The 

13 Secretary shall waive under paragraph (1)(E) 

14 the application fee for the first animal drug ap15 plication that a small business or its affiliate 

16 submits to the Secretary for review. After a 

17 small business or its affiliate is granted such a 

18 waiver, the small business or its affiliate shall 

19 pay application fees for all subsequent animal 

20 drug applications and supplemental animal 

21 drug applications for which safety or effective22 ness data are required in the same manner as 

23 an entity that does not qualify as a small busi24 ness. 


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1 ‘‘(C) CERTIFICATION.—The Secretary shall 

2 require any person who applies for a waiver 

3 under paragraph (1)(E) to certify their quali4 fication for the waiver. The Secretary shall peri5 odically publish in the Federal Register a list of 

6 persons making such certifications. 

7 ‘‘(e) EFFECT OF FAILURE TO PAY FEES.—An ani8 mal drug application or supplemental animal drug applica9 tion submitted by a person subject to fees under sub10 section (a) shall be considered incomplete and shall not 

11 be accepted for filing by the Secretary until all fees owed 

12 by such person have been paid. An investigational animal 

13 drug submission under section 739(5)(B) that is sub14 mitted by a person subject to fees under subsection (a) 

15 shall be considered incomplete and shall not be accepted 

16 for review by the Secretary until all fees owed by such 

17 person have been paid. The Secretary may discontinue re18 view of any animal drug application, supplemental animal 

19 drug application, or investigational animal drug submis20 sion from a person if such person has not submitted for 

21 payment all fees owed under this section by 30 days after 

22 the date upon which they are due. 

23 ‘‘(f) ASSESSMENT OF FEES.— 

24 ‘‘(1) LIMITATION.—Fees may not be assessed 

25 under subsection (a) for a fiscal year beginning after 


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1 fiscal year 2003 unless appropriations for salaries 

2 and expenses of the Food and Drug Administration 

3 for such fiscal year (excluding the amount of fees 

4 appropriated for such fiscal year) are equal to or 

5 greater than the amount of appropriations for the 

6 salaries and expenses of the Food and Drug Admin7 istration for the fiscal year 2003 (excluding the 

8 amount of fees appropriated for such fiscal year) 

9 multiplied by the adjustment factor applicable to the 

10 fiscal year involved. 

11 ‘‘(2) AUTHORITY.—If the Secretary does not 

12 assess fees under subsection (a) during any portion 

13 of a fiscal year because of paragraph (1) and if at 

14 a later date in such fiscal year the Secretary may as15 sess such fees, the Secretary may assess and collect 

16 such fees, without any modification in the rate, for 

17 animal drug applications, supplemental animal drug 

18 applications, investigational animal drug submis19 sions, animal drug sponsors, animal drug establish20 ments, and animal drug products at any time in 

21 such fiscal year notwithstanding the provisions of 

22 subsection (a) relating to the date fees are to be 

23 paid. 

24 ‘‘(g) CREDITING AND AVAILABILITY OF FEES.— 


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1 ‘‘(1) IN GENERAL.—Subject to paragraph 

2 (2)(C), fees authorized under subsection (a) shall be 

3 collected and available for obligation only to the ex4 tent and in the amount provided in advance in ap5 propriations Acts. Such fees are authorized to be ap6 propriated to remain available until expended. Such 

7 sums as may be necessary may be transferred from 

8 the Food and Drug Administration salaries and ex9 penses appropriation account without fiscal year lim10 itation to such appropriation account for salary and 

11 expenses with such fiscal year limitation. The sums 

12 transferred shall be available solely for the process 

13 for the review of animal drug applications. 

14 ‘‘(2) COLLECTIONS AND APPROPRIATION

15 ACTS.— 

16 ‘‘(A) IN GENERAL.—The fees authorized 

17 by this section— 

18 ‘‘(i) subject to subparagraph (C), shall 

19 be collected and available in each fiscal 

20 year in an amount not to exceed the 

21 amount specified in appropriation Acts, or 

22 otherwise made available for obligation for 

23 such fiscal year; and 

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1 cated for the process for the review of ani2 mal drug applications (including increases 

3 in such costs for an additional number of 

4 full-time equivalent positions in the De5 partment of Health and Human Services 

6 to be engaged in such process) over such 

7 costs, excluding costs paid from fees col8 lected under this section, for fiscal year 

9 2003 multiplied by the adjustment factor. 

10 ‘‘(B) COMPLIANCE.—The Secretary shall 

11 be considered to have met the requirements of 

12 subparagraph (A)(ii) in any fiscal year if the 

13 costs funded by appropriations and allocated for 

14 the process for the review of animal drug appli15 cations— 

16 ‘‘(i) are not more than 3 percent 

17 below the level specified in subparagraph 

18 (A)(ii); or 

19 ‘‘(ii)(I) are more than 3 percent below 

20 the level specified in subparagraph (A)(ii), 

21 and fees assessed for the fiscal year fol22 lowing the subsequent fiscal year are de23 creased by the amount in excess of 3 per24 cent by which such costs fell below the 

25 level specified in subparagraph (A)(ii); and 


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1 ‘‘(II) such costs are not more than 5 

2 percent below the level specified in sub3 paragraph (A)(ii). 

4 ‘‘(C) PROVISION FOR EARLY PAYMENTS.— 

5 Payment of fees authorized under this section 

6 for a fiscal year, prior to the due date for such 

7 fees, may be accepted by the Secretary in ac8 cordance with authority provided in advance in 

9 a prior year appropriations Act. 

10 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

11 For each of the fiscal years 2014 through 2018, 

12 there is authorized to be appropriated for fees under 

13 this section an amount equal to the total revenue 

14 amount determined under subsection (b) for the fis15 cal year, as adjusted or otherwise affected under 

16 subsection (c) and paragraph (4). 

17 ‘‘(4) OFFSET OF OVERCOLLECTIONS; RECOVERY

18 OF COLLECTION SHORTFALLS.— 

19 ‘‘(A) OFFSET OF OVERCOLLECTIONS.—If 

20 the sum of the cumulative amount of fees col21 lected under this section for fiscal years 2014 

22 through 2016 and the amount of fees estimated 

23 to be collected under this section for fiscal year 

24 2017 (including any increased fee collections at25 tributable to subparagraph (B)), exceeds the 


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1 cumulative amount appropriated pursuant to 

2 paragraph (3) for the fiscal years 2014 through 

3 2017, the excess amount shall be credited to 

4 the appropriation account of the Food and 

5 Drug Administration as provided in paragraph 

6 (1), and shall be subtracted from the amount of 

7 fees that would otherwise be authorized to be 

8 collected under this section pursuant to appro9 priation Acts for fiscal year 2018. 

10 ‘‘(B) RECOVERY OF COLLECTION SHORT11 FALLS.— 

12 ‘‘(i) FISCAL YEAR 2016.—For fiscal 

13 year 2016, the amount of fees otherwise 

14 authorized to be collected under this sec15 tion shall be increased by the amount, if 

16 any, by which the amount collected under 

17 this section and appropriated for fiscal 

18 year 2014 falls below the amount of fees 

19 authorized for fiscal year 2014 under para20 graph (3). 

21 ‘‘(ii) FISCAL YEAR 2017.—For fiscal 

22 year 2017, the amount of fees otherwise 

23 authorized to be collected under this sec24 tion shall be increased by the amount, if 

25 any, by which the amount collected under 


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1 this section and appropriated for fiscal 

2 year 2015 falls below the amount of fees 

3 authorized for fiscal year 2015 under para4 graph (3). 

5 ‘‘(iii) FISCAL YEAR 2018.—For fiscal 

6 year 2018, the amount of fees otherwise 

7 authorized to be collected under this sec8 tion (including any reduction in the au9 thorized amount under subparagraph (A)), 

10 shall be increased by the cumulative 

11 amount, if any, by which the amount col12 lected under this section and appropriated 

13 for fiscal years 2016 and 2017 (including 

14 estimated collections for fiscal year 2017) 

15 falls below the cumulative amount of fees 

16 authorized under paragraph (3) for fiscal 

17 years 2016 and 2017. 

18 ‘‘(h) COLLECTION OF UNPAID FEES.—In any case 

19 where the Secretary does not receive payment of a fee as20 sessed under subsection (a) within 30 days after it is due, 

21 such fee shall be treated as a claim of the United States 

22 Government subject to subchapter II of chapter 37 of title 

23 31, United States Code. 

24 ‘‘(i) WRITTEN REQUESTS FOR WAIVERS, REDUC25 TIONS, AND REFUNDS.—To qualify for consideration for 


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1 a waiver or reduction under subsection (d), or for a refund 

2 of any fee collected in accordance with subsection (a), a 

3 person shall submit to the Secretary a written request for 

4 such waiver, reduction, or refund not later than 180 days 

5 after such fee is due. 

6 ‘‘(j) CONSTRUCTION.—This section may not be con7 strued to require that the number of full-time equivalent 

8 positions in the Department of Health and Human Serv9 ices, for officers, employees, and advisory committees not 

10 engaged in the process of the review of animal drug appli11 cations, be reduced to offset the number of officers, em12 ployees, and advisory committees so engaged. 

13 ‘‘(k) ABBREVIATED NEW ANIMAL DRUG APPLICA14 TIONS.—The Secretary shall— 

15 ‘‘(1) to the extent practicable, segregate the re16 view of abbreviated new animal drug applications 

17 from the process for the review of animal drug appli18 cations; and 

19 ‘‘(2) adopt other administrative procedures to 

20 ensure that review times of abbreviated new animal 

21 drug applications do not increase from their current 

22 level due to activities under the user fee program.’’. 


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1 SEC. 4. REAUTHORIZATION; REPORTING REQUIREMENTS. 

2 Section 740A of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 379j–13) is amended to read as fol4 lows: 

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

7 ‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal 

8 year 2014, not later than 120 days after the end of each 

9 fiscal year during which fees are collected under this part, 

10 the Secretary shall prepare and submit to the Committee 

11 on Energy and Commerce of the House of Representatives 

12 and the Committee on Health, Education, Labor, and 

13 Pensions of the Senate a report concerning the progress 

14 of the Food and Drug Administration in achieving the 

15 goals identified in the letters described in section 1(b) of 

16 the Animal Drug User Fee Amendments of 2013 toward 

17 expediting the animal drug development process and the 

18 review of the new and supplemental animal drug applica19 tions and investigational animal drug submissions during 

20 such fiscal year, the future plans of the Food and Drug 

21 Administration for meeting the goals, the review times for 

22 abbreviated new animal drug applications, and the admin23 istrative procedures adopted by the Food and Drug Ad24 ministration to ensure that review times for abbreviated 

25 new animal drug applications are not increased from their 

26 current level due to activities under the user fee program. 


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1 ‘‘(b) FISCAL REPORT.—Beginning with fiscal year 

2 2014, not later than 120 days after the end of each fiscal 

3 year during which fees are collected under this part, the 

4 Secretary shall prepare and submit to the Committee on 

5 Energy and Commerce of the House of Representatives 

6 and the Committee on Health, Education, Labor, and 

7 Pensions of the Senate a report on the implementation 

8 of the authority for such fees during such fiscal year and 

9 the use, by the Food and Drug Administration, of the fees 

10 collected during such fiscal year for which the report is 

11 made. 

12 ‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall 

13 make the reports required under subsections (a) and (b) 

14 available to the public on the Internet Web site of the 

15 Food and Drug Administration. 

16 ‘‘(d) REAUTHORIZATION.— 

17 ‘‘(1) CONSULTATION.—In developing rec18 ommendations to present to the Congress with re19 spect to the goals, and plans for meeting the goals, 

20 for the process for the review of animal drug appli21 cations for the first 5 fiscal years after fiscal year 

22 2018, and for the reauthorization of this part for 

23 such fiscal years, the Secretary shall consult with— 

24 ‘‘(A) the Committee on Energy and Com25 merce of the House of Representatives; 


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1 ‘‘(B) the Committee on Health, Education, 

2 Labor, and Pensions of the Senate; 

3 ‘‘(C) scientific and academic experts; 

4 ‘‘(D) veterinary professionals; 

5 ‘‘(E) representatives of patient and con6 sumer advocacy groups; and 

7 ‘‘(F) the regulated industry. 

8 ‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning 

9 negotiations with the regulated industry on the reau10 thorization of this part, the Secretary shall— 

11 ‘‘(A) publish a notice in the Federal Reg12 ister requesting public input on the reauthoriza13 tion; 

14 ‘‘(B) hold a public meeting at which the 

15 public may present its views on the reauthoriza16 tion, including specific suggestions for changes 

17 to the goals referred to in subsection (a); 

18 ‘‘(C) provide a period of 30 days after the 

19 public meeting to obtain written comments from 

20 the public suggesting changes to this part; and 

21 ‘‘(D) publish the comments on the Food 

22 and Drug Administration’s Internet Web site. 

23 ‘‘(3) PERIODIC CONSULTATION.—Not less fre24 quently than once every 4 months during negotia25 tions with the regulated industry, the Secretary shall 


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1 hold discussions with representatives of veterinary, 

2 patient, and consumer advocacy groups to continue 

3 discussions of their views on the reauthorization and 

4 their suggestions for changes to this part as ex5 pressed under paragraph (2). 

6 ‘‘(4) PUBLIC REVIEW OF RECOMMENDA7 TIONS.—After negotiations with the regulated indus8 try, the Secretary shall— 

9 ‘‘(A) present the recommendations devel10 oped under paragraph (1) to the congressional 

11 committees specified in such paragraph; 

12 ‘‘(B) publish such recommendations in the 

13 Federal Register; 

14 ‘‘(C) provide for a period of 30 days for 

15 the public to provide written comments on such 

16 recommendations; 

17 ‘‘(D) hold a meeting at which the public 

18 may present its views on such recommenda19 tions; and 

20 ‘‘(E) after consideration of such public 

21 views and comments, revise such recommenda22 tions as necessary. 

23 ‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.— 

24 Not later than January 15, 2018, the Secretary 

25 shall transmit to Congress the revised recommendaVerDate Mar 15 2010 02:35 Apr 11, 2013 Jkt 029200 PO 00000 Frm 00033 Fmt 6652 Sfmt 6201 E:\BILLS\H1407.IH H1407

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1 tions under paragraph (4), a summary of the views 

2 and comments received under such paragraph, and 

3 any changes made to the recommendations in re4 sponse to such views and comments. 

5 ‘‘(6) MINUTES OF NEGOTIATION MEETINGS.— 

6 ‘‘(A) PUBLIC AVAILABILITY.—Before pre7 senting the recommendations developed under 

8 paragraphs (1) through (5) to Congress, the 

9 Secretary shall make publicly available, on the 

10 Internet Web site of the Food and Drug Ad11 ministration, minutes of all negotiation meet12 ings conducted under this subsection between 

13 the Food and Drug Administration and the reg14 ulated industry. 

15 ‘‘(B) CONTENT.—The minutes described 

16 under subparagraph (A) shall summarize any 

17 substantive proposal made by any party to the 

18 negotiations as well as significant controversies 

19 or differences of opinion during the negotiations 

20 and their resolution.’’. 

21 SEC. 5. SAVINGS CLAUSE. 

22 Notwithstanding the amendments made by this Act, 

23 part 4 of subchapter C of chapter VII of the Federal Food, 

24 Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as 

25 in effect on the day before the date of the enactment of 


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1 this Act, shall continue to be in effect with respect to ani2 mal drug applications and supplemental animal drug ap3 plications (as defined in such part as of such day) that 

4 on or after October 1, 2008, but before October 1, 2013, 

5 were accepted by the Food and Drug Administration for 

6 filing with respect to assessing and collecting any fee re7 quired by such part for a fiscal year prior to fiscal year 

8 2014. 

9 SEC. 6. EFFECTIVE DATE. 

10 The amendments made by this Act shall take effect 

11 on October 1, 2013, or the date of enactment of this Act, 

12 whichever is later, except that fees under part 4 of sub13 chapter C of chapter VII of the Federal Food, Drug, and 

14 Cosmetic Act, as amended by this Act, shall be assessed 

15 for all animal drug applications and supplemental animal 

16 drug applications received on or after October 1, 2013, 

17 regardless of the date of the enactment of this Act. 

18 SEC. 7. SUNSET DATES. 

19 (a) AUTHORIZATION.—Section 740 of the Federal 

20 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12) shall 

21 cease to be effective October 1, 2018. 

22 (b) REPORTING REQUIREMENTS.—Section 740A of 

23 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

24 379j–13) shall cease to be effective January 31, 2019. 

25 (c) PREVIOUS SUNSET PROVISION.— 


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1 (1) IN GENERAL.—Section 108 of the Animal 

2 Drug User Fee Amendments of 2008 (Public Law 

3 110–316) is repealed. 

4 (2) CONFORMING AMENDMENT.—The Animal 

5 Drug User Fee Amendments of 2008 (Public Law 

6 110–316) is amended in the table of contents in sec7 tion 1, by striking the item relating to section 108. 

8 (d) TECHNICAL CLARIFICATION.—Effective Novem9 ber 18, 2003, section 5 of the Animal Drug User Fee Act 

10 of 2003 (Public Law 108–130) is repealed. 

Æ 


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