113TH CONGRESS 

1ST SESSION S. 622 

AN ACT 

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

reauthorize user fee programs relating to new animal 

drugs and generic new animal drugs. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Animal Drug and Ani3 mal Generic Drug User Fee Reauthorization Act of 

4 2013’’. 

5 SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT. 

6 (a) TABLE OF CONTENTS.—The table of contents of 

7 this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents; references in Act. 

TITLE I—FEES RELATING TO ANIMAL DRUGS 

Sec. 101. Short title; finding. 

Sec. 102. Definitions. 

Sec. 103. Authority to assess and use animal drug fees. 

Sec. 104. Reauthorization; reporting requirements. 

Sec. 105. Savings clause. 

Sec. 106. Effective date. 

Sec. 107. Sunset dates. 

TITLE II—FEES RELATING TO GENERIC ANIMAL DRUGS 

Sec. 201. Short title; finding. 

Sec. 202. Authority to assess and use generic new animal drug fees. 

Sec. 203. Reauthorization; reporting requirements. 

Sec. 204. Savings clause. 

Sec. 205. Effective date. 

Sec. 206. Sunset dates. 

8 (b) REFERENCES IN ACT.—Except as otherwise spec9 ified, amendments made by this Act to a section or other 

10 provision of law are amendments to such section or other 

11 provision of the Federal Food, Drug, and Cosmetic Act 

12 (21 U.S.C. 301 et seq.). 
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1 TITLE I—FEES RELATING TO 

2 ANIMAL DRUGS 

3 SEC. 101. SHORT TITLE; FINDING. 

4 (a) SHORT TITLE.—This title 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 title will be dedi8 cated toward expediting the animal drug development 

9 process and the review of new and supplemental animal 

10 drug applications and investigational animal drug submis11 sions as set forth in the goals identified, for purposes of 

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

13 Drug, and Cosmetic Act, in the letters from the Secretary 

14 of Health and Human Services to the Chairman of the 

15 Committee on Energy and Commerce of the House of 

16 Representatives and the Chairman of the Committee on 

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

18 set forth in the Congressional Record. 

19 SEC. 102. DEFINITIONS. 

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

21 Act (21 U.S.C. 379j–11) is amended to read as follows: 

22 ‘‘SEC. 739. DEFINITIONS. 

23 ‘‘For purposes of this part: 

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

25 an application for approval of any new animal drug 
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1 submitted under section 512(b)(1). Such term does 

2 not include either a new animal drug application 

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

4 animal drug application. 

5 ‘‘(2) The term ‘supplemental animal drug appli6 cation’ means— 

7 ‘‘(A) a request to the Secretary to approve 

8 a change in an animal drug application which 

9 has been approved; or 

10 ‘‘(B) a request to the Secretary to approve 

11 a change to an application approved under sec12 tion 512(c)(2) for which data with respect to 

13 safety or effectiveness are required. 

14 ‘‘(3) The term ‘animal drug product’ means 

15 each specific strength or potency of a particular ac16 tive ingredient or ingredients in final dosage form 

17 marketed by a particular manufacturer or dis18 tributor, which is uniquely identified by the labeler 

19 code and product code portions of the national drug 

20 code, and for which an animal drug application or 

21 a supplemental animal drug application has been ap22 proved. 

23 ‘‘(4) The term ‘animal drug establishment’ 

24 means a foreign or domestic place of business which 

25 is at one general physical location consisting of one 
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1 or more buildings all of which are within 5 miles of 

2 each other, at which one or more animal drug prod3 ucts are manufactured in final dosage form. 

4 ‘‘(5) The term ‘investigational animal drug sub5 mission’ means— 

6 ‘‘(A) the filing of a claim for an investiga7 tional exemption under section 512(j) for a new 

8 animal drug intended to be the subject of an 

9 animal drug application or a supplemental ani10 mal drug application; or 

11 ‘‘(B) the submission of information for the 

12 purpose of enabling the Secretary to evaluate 

13 the safety or effectiveness of an animal drug 

14 application or supplemental animal drug appli15 cation in the event of their filing. 

16 ‘‘(6) The term ‘animal drug sponsor’ means ei17 ther an applicant named in an animal drug applica18 tion that has not been withdrawn by the applicant 

19 and for which approval has not been withdrawn by 

20 the Secretary, or a person who has submitted an in21 vestigational animal drug submission that has not 

22 been terminated or otherwise rendered inactive by 

23 the Secretary. 

24 ‘‘(7) The term ‘final dosage form’ means, with 

25 respect to an animal drug product, a finished dosage 
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1 form which is approved for administration to an ani2 mal without substantial further manufacturing. Such 

3 term includes animal drug products intended for 

4 mixing in animal feeds. 

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

6 drug applications’ means the following activities of 

7 the Secretary with respect to the review of animal 

8 drug applications, supplemental animal drug applica9 tions, and investigational animal drug submissions: 

10 ‘‘(A) The activities necessary for the re11 view of animal drug applications, supplemental 

12 animal drug applications, and investigational 

13 animal drug submissions. 

14 ‘‘(B) The issuance of action letters which 

15 approve animal drug applications or supple16 mental animal drug applications or which set 

17 forth in detail the specific deficiencies in animal 

18 drug applications, supplemental animal drug 

19 applications, or investigational animal drug sub20 missions and, where appropriate, the actions 

21 necessary to place such applications, supple22 ments or submissions in condition for approval. 

23 ‘‘(C) The inspection of animal drug estab24 lishments and other facilities undertaken as 

25 part of the Secretary’s review of pending animal 
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1 drug applications, supplemental animal drug 

2 applications, and investigational animal drug 

3 submissions. 

4 ‘‘(D) Monitoring of research conducted in 

5 connection with the review of animal drug ap6 plications, supplemental animal drug applica7 tions, and investigational animal drug submis8 sions. 

9 ‘‘(E) The development of regulations and 

10 policy related to the review of animal drug ap11 plications, supplemental animal drug applica12 tions, and investigational animal drug submis13 sions. 

14 ‘‘(F) Development of standards for prod15 ucts subject to review. 

16 ‘‘(G) Meetings between the agency and the 

17 animal drug sponsor. 

18 ‘‘(H) Review of advertising and labeling 

19 prior to approval of an animal drug application 

20 or supplemental animal drug application, but 

21 not after such application has been approved. 

22 ‘‘(9) The term ‘costs of resources allocated for 

23 the process for the review of animal drug applica24 tions’ means the expenses in connection with the 
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1 process for the review of animal drug applications 

2 for— 

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

4 and Drug Administration, contractors of the 

5 Food and Drug Administration, advisory com6 mittees consulted with respect to the review of 

7 specific animal drug applications, supplemental 

8 animal drug applications, or investigational ani9 mal drug submissions, and costs related to such 

10 officers, employees, committees, and contrac11 tors, including costs for travel, education, and 

12 recruitment and other personnel activities; 

13 ‘‘(B) management of information and the 

14 acquisition, maintenance, and repair of com15 puter resources; 

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

17 repair of facilities and acquisition, maintenance, 

18 and repair of fixtures, furniture, scientific 

19 equipment, and other necessary materials and 

20 supplies; and 

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

22 accounting for resources allocated for the re23 view of animal drug applications, supplemental 

24 animal drug applications, and investigational 

25 animal drug submissions. 
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1 ‘‘(10) The term ‘adjustment factor’ applicable 

2 to a fiscal year refers to the formula set forth in sec3 tion 735(8) with the base or comparator month 

4 being October 2002. 

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

6 thereof. 

7 ‘‘(12) The term ‘affiliate’ refers to the defini8 tion set forth in section 735(11).’’. 

9 SEC. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG 

10 FEES. 

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

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

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

14 FEES. 

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

16 2004, the Secretary shall assess and collect fees in accord17 ance with this section as follows: 

18 ‘‘(1) ANIMAL DRUG APPLICATION AND SUPPLE19 MENT FEE.— 

20 ‘‘(A) IN GENERAL.—Each person that sub21 mits, on or after September 1, 2003, an animal 

22 drug application or a supplemental animal drug 

23 application shall be subject to a fee as follows: 

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

25 for an animal drug application, except an 
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1 animal drug application subject to the cri2 teria set forth in section 512(d)(4). 

3 ‘‘(ii) A fee established in subsection 

4 (c), in an amount that is equal to 50 per5 cent of the amount of the fee under clause 

6 (i), for— 

7 ‘‘(I) a supplemental animal drug 

8 application for which safety or effec9 tiveness data are required; and 

10 ‘‘(II) an animal drug application 

11 subject to the criteria set forth in sec12 tion 512(d)(4). 

13 ‘‘(B) PAYMENT.—The fee required by sub14 paragraph (A) shall be due upon submission of 

15 the animal drug application or supplemental 

16 animal drug application. 

17 ‘‘(C) EXCEPTION FOR PREVIOUSLY FILED

18 APPLICATION OR SUPPLEMENT.—If an animal 

19 drug application or a supplemental animal drug 

20 application was submitted by a person that paid 

21 the fee for such application or supplement, was 

22 accepted for filing, and was not approved or 

23 was withdrawn (without a waiver or refund), 

24 the submission of an animal drug application or 

25 a supplemental animal drug application for the 
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1 same product by the same person (or the per2 son’s licensee, assignee, or successor) shall not 

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

4 ‘‘(D) REFUND OF FEE IF APPLICATION RE5 FUSED FOR FILING.—The Secretary shall re6 fund 75 percent of the fee paid under subpara7 graph (B) for any animal drug application or 

8 supplemental animal drug application which is 

9 refused for filing. 

10 ‘‘(E) REFUND OF FEE IF APPLICATION

11 WITHDRAWN.—If an animal drug application or 

12 a supplemental animal drug application is with13 drawn after the application or supplement was 

14 filed, the Secretary may refund the fee or por15 tion of the fee paid under subparagraph (B) if 

16 no substantial work was performed on the ap17 plication or supplement after the application or 

18 supplement was filed. The Secretary shall have 

19 the sole discretion to refund the fee under this 

20 paragraph. A determination by the Secretary 

21 concerning a refund under this paragraph shall 

22 not be reviewable. 

23 ‘‘(2) ANIMAL DRUG PRODUCT FEE.— 

24 ‘‘(A) IN GENERAL.—Each person— 
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1 ‘‘(i) who is named as the applicant in 

2 an animal drug application or supple3 mental animal drug application for an ani4 mal drug product which has been sub5 mitted for listing under section 510; and 

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

7 had pending before the Secretary an ani8 mal drug application or supplemental ani9 mal drug application, 

10 shall pay for each such animal drug product the 

11 annual fee established in subsection (c). 

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

13 shall be payable for the fiscal year in which the 

14 animal drug product is first submitted for list15 ing under section 510, or is submitted for re16 listing under section 510 if the animal drug 

17 product has been withdrawn from listing and 

18 relisted. After such fee is paid for that fiscal 

19 year, such fee shall be due each subsequent fis20 cal year that the product remains listed, upon 

21 the later of— 

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

23 date of enactment of an appropriations Act 

24 providing for the collection and obligation 
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1 of fees for such fiscal year under this sec2 tion; or 

3 ‘‘(ii) January 31 of each year. 

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

5 only once for each animal drug product for a 

6 fiscal year in which the fee is payable. 

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

8 ‘‘(A) IN GENERAL.—Each person— 

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

10 through an affiliate, an animal drug estab11 lishment; 

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

13 an animal drug application or supple14 mental animal drug application for an ani15 mal drug product which has been sub16 mitted for listing under section 510; and 

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

18 had pending before the Secretary an ani19 mal drug application or supplemental ani20 mal drug application, 

21 shall be assessed an annual establishment fee as 

22 established in subsection (c) for each animal 

23 drug establishment listed in its approved animal 

24 drug application as an establishment that man-
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1 ufactures the animal drug product named in the 

2 application. 

3 ‘‘(B) PAYMENT; FEE DUE DATE.—The an4 nual establishment fee shall be assessed in each 

5 fiscal year in which the animal drug product 

6 named in the application is assessed a fee under 

7 paragraph (2) unless the animal drug establish8 ment listed in the application does not engage 

9 in the manufacture of the animal drug product 

10 during the fiscal year. The fee under this para11 graph for a fiscal year shall be due upon the 

12 later of— 

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

14 date of enactment of an appropriations Act 

15 providing for the collection and obligation 

16 of fees for such fiscal year under this sec17 tion; or 

18 ‘‘(ii) January 31 of each year. 

19 ‘‘(C) LIMITATION.— 

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

21 shall be assessed only one fee per fiscal 

22 year under this section, subject to clause 

23 (ii). 

24 ‘‘(ii) CERTAIN MANUFACTURERS.—If 

25 a single establishment manufactures both 
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1 animal drug products and prescription 

2 drug products, as defined in section 

3 735(3), such establishment shall be as4 sessed both the animal drug establishment 

5 fee and the prescription drug establish6 ment fee, as set forth in section 736(a)(2), 

7 within a single fiscal year. 

8 ‘‘(4) ANIMAL DRUG SPONSOR FEE.— 

9 ‘‘(A) IN GENERAL.—Each person— 

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

11 animal drug sponsor within a fiscal year; 

12 and 

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

14 had pending before the Secretary an ani15 mal drug application, a supplemental ani16 mal drug application, or an investigational 

17 animal drug submission, 

18 shall be assessed an annual sponsor fee as es19 tablished under subsection (c). 

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

21 under this paragraph for a fiscal year shall be 

22 due upon the later of— 

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

24 date of enactment of an appropriations Act 

25 providing for the collection and obligation 
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1 of fees for such fiscal year under this sec2 tion; or 

3 ‘‘(ii) January 31 of each year. 

4 ‘‘(C) LIMITATION.—Each animal drug 

5 sponsor shall pay only one such fee each fiscal 

6 year. 

7 ‘‘(b) FEE REVENUE AMOUNTS.— 

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

9 (d), (f), and (g)— 

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

11 under subsection (a) shall be established to gen12 erate a total revenue amount of $23,600,000; 

13 and 

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

15 2018, the fees required under subsection (a) 

16 shall be established to generate a total revenue 

17 amount of $21,600,000. 

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

19 amount determined for a fiscal year under para20 graph (1)— 

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

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

23 drug applications and supplements); 
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1 ‘‘(B) 27 percent shall be derived from fees 

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

3 drug products); 

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

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

6 drug establishments); and 

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

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

9 drug sponsors). 

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

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

12 shall establish, 60 days before the start of each fis13 cal year beginning after September 30, 2003, for 

14 that fiscal year, animal drug application fees, sup15 plemental animal drug application fees, animal drug 

16 sponsor fees, animal drug establishment fees, and 

17 animal drug product fees based on the revenue 

18 amounts established under subsection (b) and the 

19 adjustments provided under this subsection. 

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

21 2015 and subsequent fiscal years, the revenue 

22 amounts established in subsection (b) shall be ad23 justed by the Secretary by notice, published in the 

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

25 equal to the sum of— 
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1 ‘‘(A) one; 

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

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

4 Food and Drug Administration, of all personnel 

5 compensation and benefits paid with respect to 

6 such positions for the first 3 of the preceding 

7 4 fiscal years for which data are available, mul8 tiplied by the average proportion of personnel 

9 compensation and benefits costs to total Food 

10 and Drug Administration costs for the first 3 

11 years of the preceding 4 fiscal years for which 

12 data are available; and 

13 ‘‘(C) the average annual percent change 

14 that occurred in the Consumer Price Index for 

15 urban consumers (Washington-Baltimore, DC– 

16 MD–VA–WV; not seasonally adjusted; all items 

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

18 3 years of the preceding 4 years for which data 

19 are available multiplied by the average propor20 tion of all costs other than personnel compensa21 tion and benefits costs to total Food and Drug 

22 Administration costs for the first 3 years of the 

23 preceding 4 fiscal years for which data are 

24 available. 
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1 The adjustment made each fiscal year under this 

2 paragraph shall be added on a compounded basis to 

3 the sum of all adjustments made each fiscal year 

4 after fiscal year 2014 under this paragraph. 

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

6 year 2015 and subsequent fiscal years, after the rev7 enue amounts established in subsection (b) are ad8 justed for inflation in accordance with paragraph 

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

10 for such fiscal year to reflect changes in the work11 load of the Secretary for the process for the review 

12 of animal drug applications. With respect to such 

13 adjustment— 

14 ‘‘(A) such adjustment shall be determined 

15 by the Secretary based on a weighted average 

16 of the change in the total number of animal 

17 drug applications, supplemental animal drug 

18 applications for which data with respect to safe19 ty or effectiveness are required, manufacturing 

20 supplemental animal drug applications, inves21 tigational animal drug study submissions, and 

22 investigational animal drug protocol submis23 sions submitted to the Secretary; 

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

25 Federal Register the fees resulting from such 
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1 adjustment and the supporting methodologies; 

2 and 

3 ‘‘(C) under no circumstances shall such ad4 justment result in fee revenues for a fiscal year 

5 that are less than the fee revenues for that fis6 cal year established in subsection (b), as ad7 justed for inflation under paragraph (2). 

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

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

10 adjustments under this subsection, further increase 

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

12 necessary, to provide for up to 3 months of oper13 ating reserves of carryover user fees for the process 

14 for the review of animal drug applications for the 

15 first 3 months of fiscal year 2019. If the Food and 

16 Drug Administration has carryover balances for the 

17 process for the review of animal drug applications in 

18 excess of 3 months of such operating reserves, then 

19 this adjustment will not be made. If this adjustment 

20 is necessary, then the rationale for the amount of 

21 the increase shall be contained in the annual notice 

22 setting fees for fiscal year 2018. 

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

24 as adjusted under this subsection, for a fiscal year 

25 may not exceed the total costs for such fiscal year 
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1 for the resources allocated for the process for the re2 view of animal drug applications. 

3 ‘‘(d) FEE WAIVER OR REDUCTION.— 

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

5 waiver from or a reduction of one or more fees as6 sessed under subsection (a) where the Secretary 

7 finds that— 

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

9 present a significant barrier to innovation be10 cause of limited resources available to such per11 son or other circumstances; 

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

13 will exceed the anticipated present and future 

14 costs incurred by the Secretary in conducting 

15 the process for the review of animal drug appli16 cations for such person; 

17 ‘‘(C) the animal drug application or sup18 plemental animal drug application is intended 

19 solely to provide for use of the animal drug 

20 in— 

21 ‘‘(i) a Type B medicated feed (as de22 fined in section 558.3(b)(3) of title 21, 

23 Code of Federal Regulations (or any suc24 cessor regulation)) intended for use in the 
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1 manufacture of Type C free-choice medi2 cated feeds; or 

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

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

5 title 21, Code of Federal Regulations (or 

6 any successor regulation)); 

7 ‘‘(D) the animal drug application or sup8 plemental animal drug application is intended 

9 solely to provide for a minor use or minor spe10 cies indication; or 

11 ‘‘(E) the sponsor involved is a small busi12 ness submitting its first animal drug applica13 tion to the Secretary for review. 

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

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

16 standard costs. 

17 ‘‘(3) RULES FOR SMALL BUSINESSES.— 

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

19 the term ‘small business’ means an entity that 

20 has fewer than 500 employees, including em21 ployees of affiliates. 

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

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

24 the application fee for the first animal drug ap25 plication that a small business or its affiliate 
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1 submits to the Secretary for review. After a 

2 small business or its affiliate is granted such a 

3 waiver, the small business or its affiliate shall 

4 pay application fees for all subsequent animal 

5 drug applications and supplemental animal 

6 drug applications for which safety or effective7 ness data are required in the same manner as 

8 an entity that does not qualify as a small busi9 ness. 

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

11 require any person who applies for a waiver 

12 under paragraph (1)(E) to certify their quali13 fication for the waiver. The Secretary shall peri14 odically publish in the Federal Register a list of 

15 persons making such certifications. 

16 ‘‘(e) EFFECT OF FAILURE TO PAY FEES.—An ani17 mal drug application or supplemental animal drug applica18 tion submitted by a person subject to fees under sub19 section (a) shall be considered incomplete and shall not 

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

21 by such person have been paid. An investigational animal 

22 drug submission under section 739(5)(B) that is sub23 mitted by a person subject to fees under subsection (a) 

24 shall be considered incomplete and shall not be accepted 

25 for review by the Secretary until all fees owed by such 
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1 person have been paid. The Secretary may discontinue re2 view of any animal drug application, supplemental animal 

3 drug application or investigational animal drug submission 

4 from a person if such person has not submitted for pay5 ment all fees owed under this section by 30 days after 

6 the date upon which they are due. 

7 ‘‘(f) ASSESSMENT OF FEES.— 

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

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

10 fiscal year 2003 unless appropriations for salaries 

11 and expenses of the Food and Drug Administration 

12 for such fiscal year (excluding the amount of fees 

13 appropriated for such fiscal year) are equal to or 

14 greater than the amount of appropriations for the 

15 salaries and expenses of the Food and Drug Admin16 istration for the fiscal year 2003 (excluding the 

17 amount of fees appropriated for such fiscal year) 

18 multiplied by the adjustment factor applicable to the 

19 fiscal year involved. 

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

21 assess fees under subsection (a) during any portion 

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

23 a later date in such fiscal year the Secretary may as24 sess such fees, the Secretary may assess and collect 

25 such fees, without any modification in the rate, for 
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1 animal drug applications, supplemental animal drug 

2 applications, investigational animal drug submis3 sions, animal drug sponsors, animal drug establish4 ments and animal drug products at any time in such 

5 fiscal year notwithstanding the provisions of sub6 section (a) relating to the date fees are to be paid. 

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

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

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

10 collected and available for obligation only to the ex11 tent and in the amount provided in advance in ap12 propriations Acts. Such fees are authorized to be ap13 propriated to remain available until expended. Such 

14 sums as may be necessary may be transferred from 

15 the Food and Drug Administration salaries and ex16 penses appropriation account without fiscal year lim17 itation to such appropriation account for salary and 

18 expenses with such fiscal year limitation. The sums 

19 transferred shall be available solely for the process 

20 for the review of animal drug applications. 

21 ‘‘(2) COLLECTIONS AND APPROPRIATION

22 ACTS.— 

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

24 by this section— 
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1 ‘‘(i) subject to subparagraph (C), shall 

2 be collected and available in each fiscal 

3 year in an amount not to exceed the 

4 amount specified in appropriation Acts, or 

5 otherwise made available for obligation for 

6 such fiscal year, and 

7 ‘‘(ii) shall be available to defray in8 creases in the costs of the resources allo9 cated for the process for the review of ani10 mal drug applications (including increases 

11 in such costs for an additional number of 

12 full-time equivalent positions in the De13 partment of Health and Human Services 

14 to be engaged in such process) over such 

15 costs, excluding costs paid from fees col16 lected under this section, for fiscal year 

17 2003 multiplied by the adjustment factor. 

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

19 be considered to have met the requirements of 

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

21 costs funded by appropriations and allocated for 

22 the process for the review of animal drug appli23 cations— 
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1 ‘‘(i) are not more than 3 percent 

2 below the level specified in subparagraph 

3 (A)(ii); or 

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

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

6 and fees assessed for the fiscal year fol7 lowing the subsequent fiscal year are de8 creased by the amount in excess of 3 per9 cent by which such costs fell below the 

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

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

12 percent below the level specified in sub13 paragraph (A)(ii). 

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

15 Payment of fees authorized under this section 

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

17 fees, may be accepted by the Secretary in ac18 cordance with authority provided in advance in 

19 a prior year appropriations Act. 

20 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

21 For each of the fiscal years 2014 through 2018, 

22 there is authorized to be appropriated for fees under 

23 this section an amount equal to the total revenue 

24 amount determined under subsection (b) for the fis-
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1 cal year, as adjusted or otherwise affected under 

2 subsection (c) and paragraph (4). 

3 ‘‘(4) OFFSET OF OVERCOLLECTIONS; RECOVERY

4 OF COLLECTION SHORTFALLS.— 

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

6 the sum of the cumulative amount of fees col7 lected under this section for fiscal years 2014 

8 through 2016 and the amount of fees estimated 

9 to be collected under this section for fiscal year 

10 2017 (including any increased fee collections at11 tributable to subparagraph (B)), exceeds the 

12 cumulative amount appropriated pursuant to 

13 paragraph (3) for the fiscal years 2014 through 

14 2017, the excess amount shall be credited to 

15 the appropriation account of the Food and 

16 Drug Administration as provided in paragraph 

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

18 fees that would otherwise be authorized to be 

19 collected under this section pursuant to appro20 priation Acts for fiscal year 2018. 

21 ‘‘(B) RECOVERY OF COLLECTION SHORT22 FALLS.— 

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

24 year 2016, the amount of fees otherwise 

25 authorized to be collected under this sec-
29 

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1 tion shall be increased by the amount, if 

2 any, by which the amount collected under 

3 this section and appropriated for fiscal 

4 year 2014 falls below the amount of fees 

5 authorized for fiscal year 2014 under para6 graph (3). 

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

8 year 2017, the amount of fees otherwise 

9 authorized to be collected under this sec10 tion shall be increased by the amount, if 

11 any, by which the amount collected under 

12 this section and appropriated for fiscal 

13 year 2015 falls below the amount of fees 

14 authorized for fiscal year 2015 under para15 graph (3). 

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

17 year 2018, the amount of fees otherwise 

18 authorized to be collected under this sec19 tion (including any reduction in the au20 thorized amount under subparagraph (A)), 

21 shall be increased by the cumulative 

22 amount, if any, by which the amount col23 lected under this section and appropriated 

24 for fiscal years 2016 and 2017 (including 

25 estimated collections for fiscal year 2017) 
30 

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1 falls below the cumulative amount of fees 

2 authorized under paragraph (3) for fiscal 

3 years 2016 and 2017. 

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

5 where the Secretary does not receive payment of a fee as6 sessed under subsection (a) within 30 days after it is due, 

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

8 Government subject to subchapter II of chapter 37 of title 

9 31, United States Code. 

10 ‘‘(i) WRITTEN REQUESTS FOR WAIVERS, REDUC11 TIONS, AND REFUNDS.—To qualify for consideration for 

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

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

14 person shall submit to the Secretary a written request for 

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

16 after such fee is due. 

17 ‘‘(j) CONSTRUCTION.—This section may not be con18 strued to require that the number of full-time equivalent 

19 positions in the Department of Health and Human Serv20 ices, for officers, employees, and advisory committees not 

21 engaged in the process of the review of animal drug appli22 cations, be reduced to offset the number of officers, em23 ployees, and advisory committees so engaged. 

24 ‘‘(k) ABBREVIATED NEW ANIMAL DRUG APPLICA25 TIONS.—The Secretary shall— 
31 

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1 ‘‘(1) to the extent practicable, segregate the re2 view of abbreviated new animal drug applications 

3 from the process for the review of animal drug appli4 cations; and 

5 ‘‘(2) adopt other administrative procedures to 

6 ensure that review times of abbreviated new animal 

7 drug applications do not increase from their current 

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

9 SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 

10 Section 740A of the Federal Food, Drug, and Cos11 metic Act (21 U.S.C. 379j–13) is amended to read as fol12 lows: 

13 ‘‘SEC. 740A. REAUTHORIZATION; REPORTING REQUIRE14 MENTS. 

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

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

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

18 the Secretary shall prepare and submit to the Committee 

19 on Health, Education, Labor, and Pensions of the Senate 

20 and the Committee on Energy and Commerce of the 

21 House of Representatives a report concerning the progress 

22 of the Food and Drug Administration in achieving the 

23 goals identified in the letters described in section 101(b) 

24 of the Animal Drug User Fee Amendments of 2013 to25 ward expediting the animal drug development process and 
32 

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1 the review of the new and supplemental animal drug appli2 cations and investigational animal drug submissions dur3 ing such fiscal year, the future plans of the Food and 

4 Drug Administration for meeting the goals, the review 

5 times for abbreviated new animal drug applications, and 

6 the administrative procedures adopted by the Food and 

7 Drug Administration to ensure that review times for ab8 breviated new animal drug applications are not increased 

9 from their current level due to activities under the user 

10 fee program. 

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

12 2014, not later than 120 days after the end of each fiscal 

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

14 Secretary shall prepare and submit to the Committee on 

15 Health, Education, Labor, and Pensions of the Senate and 

16 the Committee on Energy and Commerce of the House 

17 of Representatives a report on the implementation of the 

18 authority for such fees during such fiscal year and the 

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

20 collected during such fiscal year for which the report is 

21 made. 

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

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

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

25 Food and Drug Administration. 
33 

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1 ‘‘(d) REAUTHORIZATION.— 

2 ‘‘(1) CONSULTATION.—In developing rec3 ommendations to present to the Congress with re4 spect to the goals, and plans for meeting the goals, 

5 for the process for the review of animal drug appli6 cations for the first 5 fiscal years after fiscal year 

7 2018, and for the reauthorization of this part for 

8 such fiscal years, the Secretary shall consult with— 

9 ‘‘(A) the Committee on Health, Education, 

10 Labor, and Pensions of the Senate; 

11 ‘‘(B) the Committee on Energy and Com12 merce of the House of Representatives; 

13 ‘‘(C) scientific and academic experts; 

14 ‘‘(D) veterinary professionals; 

15 ‘‘(E) representatives of patient and con16 sumer advocacy groups; and 

17 ‘‘(F) the regulated industry. 

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

19 negotiations with the regulated industry on the reau20 thorization of this part, the Secretary shall— 

21 ‘‘(A) publish a notice in the Federal Reg22 ister requesting public input on the reauthoriza23 tion; 

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

25 public may present its views on the reauthoriza-
34 

†S 622 ES

1 tion, including specific suggestions for changes 

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

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

4 public meeting to obtain written comments from 

5 the public suggesting changes to this part; and 

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

7 and Drug Administration’s Internet Web site. 

8 ‘‘(3) PERIODIC CONSULTATION.—Not less fre9 quently than once every 4 months during negotia10 tions with the regulated industry, the Secretary shall 

11 hold discussions with representatives of veterinary, 

12 patient, and consumer advocacy groups to continue 

13 discussions of their views on the reauthorization and 

14 their suggestions for changes to this part as ex15 pressed under paragraph (2). 

16 ‘‘(4) PUBLIC REVIEW OF RECOMMENDA17 TIONS.—After negotiations with the regulated indus18 try, the Secretary shall— 

19 ‘‘(A) present the recommendations devel20 oped under paragraph (1) to the Congressional 

21 committees specified in such paragraph; 

22 ‘‘(B) publish such recommendations in the 

23 Federal Register; 
35 

†S 622 ES

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

2 the public to provide written comments on such 

3 recommendations; 

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

5 may present its views on such recommenda6 tions; and 

7 ‘‘(E) after consideration of such public 

8 views and comments, revise such recommenda9 tions as necessary. 

10 ‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.— 

11 Not later than January 15, 2018, the Secretary 

12 shall transmit to Congress the revised recommenda13 tions under paragraph (4) a summary of the views 

14 and comments received under such paragraph, and 

15 any changes made to the recommendations in re16 sponse to such views and comments. 

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

18 ‘‘(A) PUBLIC AVAILABILITY.—Before pre19 senting the recommendations developed under 

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

21 Secretary shall make publicly available, on the 

22 Internet Web site of the Food and Drug Ad23 ministration, minutes of all negotiation meet24 ings conducted under this subsection between 
36 

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1 the Food and Drug Administration and the reg2 ulated industry. 

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

4 under subparagraph (A) shall summarize any 

5 substantive proposal made by any party to the 

6 negotiations as well as significant controversies 

7 or differences of opinion during the negotiations 

8 and their resolution.’’. 

9 SEC. 105. SAVINGS CLAUSE. 

10 Notwithstanding the amendments made by this title, 

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

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

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

14 this title, shall continue to be in effect with respect to ani15 mal drug applications and supplemental animal drug ap16 plications (as defined in such part as of such day) that 

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

18 were accepted by the Food and Drug Administration for 

19 filing with respect to assessing and collecting any fee re20 quired by such part for a fiscal year prior to fiscal year 

21 2014. 

22 SEC. 106. EFFECTIVE DATE. 

23 The amendments made by this title shall take effect 

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

25 whichever is later, except that fees under part 4 of sub-
37 

†S 622 ES

1 chapter C of chapter VII of the Federal Food, Drug, and 

2 Cosmetic Act, as amended by this title, shall be assessed 

3 for all animal drug applications and supplemental animal 

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

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

6 SEC. 107. SUNSET DATES. 

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

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

9 cease to be effective October 1, 2018. 

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

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

12 379j–13) shall cease to be effective January 31, 2019. 

13 (c) PREVIOUS SUNSET PROVISION.— 

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

15 Drug User Fee Amendments of 2008 (Public Law 

16 110–316) is repealed. 

17 (2) CONFORMING AMENDMENT.—The Animal 

18 Drug User Fee Amendments of 2008 (Public Law 

19 110–316) is amended in the table of contents in sec20 tion 1, by striking the item relating to section 108. 

21 (d) TECHNICAL CLARIFICATION.—Effective Novem22 ber 18, 2003, section 5 of the Animal Drug User Fee Act 

23 of 2003 (Public Law 108–130) is repealed. 
38 

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1 TITLE II—FEES RELATING TO 

2 GENERIC ANIMAL DRUGS 

3 SEC. 201. SHORT TITLE; FINDING. 

4 (a) SHORT TITLE.—This title may be cited as the 

5 ‘‘Animal Generic Drug User Fee Amendments of 2013’’. 

6 (b) FINDING.—The fees authorized by this title will 

7 be dedicated toward expediting the generic new animal 

8 drug development process and the review of abbreviated 

9 applications for generic new animal drugs, supplemental 

10 abbreviated applications for generic new animal drugs, 

11 and investigational submissions for generic new animal 

12 drugs as set forth in the goals identified in the letters from 

13 the Secretary of Health and Human Services to the Chair14 man of the Committee on Energy and Commerce of the 

15 House of Representatives and the Chairman of the Com16 mittee on Health, Education, Labor, and Pensions of the 

17 Senate as set forth in the Congressional Record. 

18 SEC. 202. AUTHORITY TO ASSESS AND USE GENERIC NEW 

19 ANIMAL DRUG FEES. 

20 Section 741 of the Federal Food, Drug, and Cosmetic 

21 Act (21 U.S.C. 379j–21) is amended to read as follows: 
39 

†S 622 ES

1 ‘‘SEC. 741. AUTHORITY TO ASSESS AND USE GENERIC NEW 

2 ANIMAL DRUG FEES. 

3 ‘‘(a) TYPES OF FEES.—Beginning with respect to fis4 cal year 2009, the Secretary shall assess and collect fees 

5 in accordance with this section as follows: 

6 ‘‘(1) ABBREVIATED APPLICATION FEE.— 

7 ‘‘(A) IN GENERAL.—Each person that sub8 mits, on or after July 1, 2008, an abbreviated 

9 application for a generic new animal drug shall 

10 be subject to a fee as established in subsection 

11 (c) for such an application. 

12 ‘‘(B) PAYMENT.—The fee required by sub13 paragraph (A) shall be due upon submission of 

14 the abbreviated application. 

15 ‘‘(C) EXCEPTIONS.— 

16 ‘‘(i) PREVIOUSLY FILED APPLICA17 TION.—If an abbreviated application was 

18 submitted by a person that paid the fee for 

19 such application, was accepted for filing, 

20 and was not approved or was withdrawn 

21 (without a waiver or refund), the submis22 sion of an abbreviated application for the 

23 same product by the same person (or the 

24 person’s licensee, assignee, or successor) 

25 shall not be subject to a fee under sub26 paragraph (A). 
40 

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1 ‘‘(ii) CERTAIN ABBREVIATED APPLICA2 TIONS INVOLVING COMBINATION ANIMAL

3 DRUGS.—An abbreviated application which 

4 is subject to the criteria in section 

5 512(d)(4) and submitted on or after Octo6 ber 1, 2013 shall be subject to a fee equal 

7 to 50 percent of the amount of the abbre8 viated application fee established in sub9 section (c). 

10 ‘‘(D) REFUND OF FEE IF APPLICATION RE11 FUSED FOR FILING.—The Secretary shall re12 fund 75 percent of the fee paid under subpara13 graph (B) for any abbreviated application which 

14 is refused for filing. 

15 ‘‘(E) REFUND OF FEE IF APPLICATION

16 WITHDRAWN.—If an abbreviated application is 

17 withdrawn after the application was filed, the 

18 Secretary may refund the fee or portion of the 

19 fee paid under subparagraph (B) if no substan20 tial work was performed on the application 

21 after the application was filed. The Secretary 

22 shall have the sole discretion to refund the fee 

23 under this subparagraph. A determination by 

24 the Secretary concerning a refund under this 

25 subparagraph shall not be reviewable. 
41 

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1 ‘‘(2) GENERIC NEW ANIMAL DRUG PRODUCT

2 FEE.— 

3 ‘‘(A) IN GENERAL.—Each person— 

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

5 an abbreviated application or supplemental 

6 abbreviated application for a generic new 

7 animal drug product which has been sub8 mitted for listing under section 510; and 

9 ‘‘(ii) who, after September 1, 2008, 

10 had pending before the Secretary an abbre11 viated application or supplemental abbre12 viated application, 

13 shall pay for each such generic new animal 

14 drug product the annual fee established in sub15 section (c). 

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

17 shall be payable for the fiscal year in which the 

18 generic new animal drug product is first sub19 mitted for listing under section 510, or is sub20 mitted for relisting under section 510 if the ge21 neric new animal drug product has been with22 drawn from listing and relisted. After such fee 

23 is paid for that fiscal year, such fee shall be due 

24 each subsequent fiscal year that the product re25 mains listed, upon the later of— 
42 

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

2 date of enactment of an appropriations Act 

3 providing for the collection and obligation 

4 of fees for such fiscal year under this sec5 tion; or 

6 ‘‘(ii) January 31 of each year. 

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

8 only once for each generic new animal drug 

9 product for a fiscal year in which the fee is pay10 able. 

11 ‘‘(3) GENERIC NEW ANIMAL DRUG SPONSOR

12 FEE.— 

13 ‘‘(A) IN GENERAL.—Each person— 

14 ‘‘(i) who meets the definition of a ge15 neric new animal drug sponsor within a 

16 fiscal year; and 

17 ‘‘(ii) who, after September 1, 2008, 

18 had pending before the Secretary an abbre19 viated application, a supplemental abbre20 viated application, or an investigational 

21 submission, 

22 shall be assessed an annual generic new animal 

23 drug sponsor fee as established under sub24 section (c). 
43 

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

2 shall be due each fiscal year upon the later of— 

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

4 date of enactment of an appropriations Act 

5 providing for the collection and obligation 

6 of fees for such fiscal year under this sec7 tion; or 

8 ‘‘(ii) January 31 of each year. 

9 ‘‘(C) AMOUNT OF FEE.—Each generic new 

10 animal drug sponsor shall pay only 1 such fee 

11 each fiscal year, as follows: 

12 ‘‘(i) 100 percent of the amount of the 

13 generic new animal drug sponsor fee pub14 lished for that fiscal year under subsection 

15 (c) for an applicant with more than 6 ap16 proved abbreviated applications. 

17 ‘‘(ii) 75 percent of the amount of the 

18 generic new animal drug sponsor fee pub19 lished for that fiscal year under subsection 

20 (c) for an applicant with more than 1 and 

21 fewer than 7 approved abbreviated applica22 tions. 

23 ‘‘(iii) 50 percent of the amount of the 

24 generic new animal drug sponsor fee pub25 lished for that fiscal year under subsection 
44 

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1 (c) for an applicant with 1 or fewer ap2 proved abbreviated applications. 

3 ‘‘(b) FEE AMOUNTS.—Subject to subsections (c), (d), 

4 (f), and (g), the fees required under subsection (a) shall 

5 be established to generate fee revenue amounts as follows: 

6 ‘‘(1) TOTAL FEE REVENUES FOR APPLICATION

7 FEES.—The total fee revenues to be collected in ab8 breviated application fees under subsection (a)(1) 

9 shall be $1,832,000 for fiscal year 2014, $1,736,000 

10 for fiscal year 2015, $1,857,000 for fiscal year 

11 2016, $1,984,000 for fiscal year 2017, and 

12 $2,117,000 for fiscal year 2018. 

13 ‘‘(2) TOTAL FEE REVENUES FOR PRODUCT

14 FEES.—The total fee revenues to be collected in ge15 neric new animal drug product fees under subsection 

16 (a)(2) shall be $2,748,000 for fiscal year 2014, 

17 $2,604,000 for fiscal year 2015, $2,786,000 for fis18 cal year 2016, $2,976,000 for fiscal year 2017, and 

19 $3,175,000 for fiscal year 2018. 

20 ‘‘(3) TOTAL FEE REVENUES FOR SPONSOR

21 FEES.—The total fee revenues to be collected in ge22 neric new animal drug sponsor fees under subsection 

23 (a)(3) shall be $2,748,000 for fiscal year 2014, 

24 $2,604,000 for fiscal year 2015, $2,786,000 for fis-
45 

†S 622 ES

1 cal year 2016, $2,976,000 for fiscal year 2017, and 

2 $3,175,000 for fiscal year 2018. 

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

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

5 shall establish, 60 days before the start of each fis6 cal year beginning after September 30, 2008, for 

7 that fiscal year, abbreviated application fees, generic 

8 new animal drug sponsor fees, and generic new ani9 mal drug product fees, based on the revenue 

10 amounts established under subsection (b) and the 

11 adjustments provided under this subsection. 

12 ‘‘(2) WORKLOAD ADJUSTMENT.—The fee reve13 nues shall be adjusted each fiscal year after fiscal 

14 year 2014 to reflect changes in review workload. 

15 With respect to such adjustment: 

16 ‘‘(A) This adjustment shall be determined 

17 by the Secretary based on a weighted average 

18 of the change in the total number of abbre19 viated applications for generic new animal 

20 drugs, manufacturing supplemental abbreviated 

21 applications for generic new animal drugs, in22 vestigational generic new animal drug study 

23 submissions, and investigational generic new 

24 animal drug protocol submissions submitted to 

25 the Secretary. The Secretary shall publish in 
46 

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1 the Federal Register the fees resulting from 

2 this adjustment and the supporting methodolo3 gies. 

4 ‘‘(B) Under no circumstances shall this 

5 workload adjustment result in fee revenues for 

6 a fiscal year that are less than the fee revenues 

7 for that fiscal year established in subsection 

8 (b). 

9 ‘‘(3) FINAL YEAR ADJUSTMENT.—For fiscal 

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

11 adjustments under this subsection, further increase 

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

13 necessary, to provide for up to 3 months of oper14 ating reserves of carryover user fees for the process 

15 for the review of abbreviated applications for generic 

16 new animal drugs for the first 3 months of fiscal 

17 year 2019. If the Food and Drug Administration 

18 has carryover balances for the process for the review 

19 of abbreviated applications for generic new animal 

20 drugs in excess of 3 months of such operating re21 serves, then this adjustment shall not be made. If 

22 this adjustment is necessary, then the rationale for 

23 the amount of the increase shall be contained in the 

24 annual notice setting fees for fiscal year 2018. 
47 

†S 622 ES

1 ‘‘(4) LIMIT.—The total amount of fees charged, 

2 as adjusted under this subsection, for a fiscal year 

3 may not exceed the total costs for such fiscal year 

4 for the resources allocated for the process for the re5 view of abbreviated applications for generic new ani6 mal drugs. 

7 ‘‘(d) FEE WAIVER OR REDUCTION.—The Secretary 

8 shall grant a waiver from or a reduction of 1 or more fees 

9 assessed under subsection (a) where the Secretary finds 

10 that the generic new animal drug is intended solely to pro11 vide for a minor use or minor species indication. 

12 ‘‘(e) EFFECT OF FAILURE TO PAY FEES.—An abbre13 viated application for a generic new animal drug sub14 mitted by a person subject to fees under subsection (a) 

15 shall be considered incomplete and shall not be accepted 

16 for filing by the Secretary until all fees owed by such per17 son have been paid. An investigational submission for a 

18 generic new animal drug that is submitted by a person 

19 subject to fees under subsection (a) shall be considered 

20 incomplete and shall not be accepted for review by the Sec21 retary until all fees owed by such person have been paid. 

22 The Secretary may discontinue review of any abbreviated 

23 application for a generic new animal drug, supplemental 

24 abbreviated application for a generic new animal drug, or 

25 investigational submission for a generic new animal drug 
48 

†S 622 ES

1 from a person if such person has not submitted for pay2 ment all fees owed under this section by 30 days after 

3 the date upon which they are due. 

4 ‘‘(f) ASSESSMENT OF FEES.— 

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

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

7 fiscal year 2008 unless appropriations for salaries 

8 and expenses of the Food and Drug Administration 

9 for such fiscal year (excluding the amount of fees 

10 appropriated for such fiscal year) are equal to or 

11 greater than the amount of appropriations for the 

12 salaries and expenses of the Food and Drug Admin13 istration for the fiscal year 2003 (excluding the 

14 amount of fees appropriated for such fiscal year) 

15 multiplied by the adjustment factor applicable to the 

16 fiscal year involved. 

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

18 assess fees under subsection (a) during any portion 

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

20 a later date in such fiscal year the Secretary may as21 sess such fees, the Secretary may assess and collect 

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

23 abbreviated applications, generic new animal drug 

24 sponsors, and generic new animal drug products at 

25 any time in such fiscal year notwithstanding the pro-
49 

†S 622 ES

1 visions of subsection (a) relating to the date fees are 

2 to be paid. 

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

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

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

6 collected and available for obligation only to the ex7 tent and in the amount provided in advance in ap8 propriations Acts. Such fees are authorized to be ap9 propriated to remain available until expended. Such 

10 sums as may be necessary may be transferred from 

11 the Food and Drug Administration salaries and ex12 penses appropriation account without fiscal year lim13 itation to such appropriation account for salary and 

14 expenses with such fiscal year limitation. The sums 

15 transferred shall be available solely for the process 

16 for the review of abbreviated applications for generic 

17 new animal drugs. 

18 ‘‘(2) COLLECTIONS AND APPROPRIATION

19 ACTS.— 

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

21 by this section— 

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

23 be collected and available in each fiscal 

24 year in an amount not to exceed the 

25 amount specified in appropriation Acts, or 
50 

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1 otherwise made available for obligation for 

2 such fiscal year; and 

3 ‘‘(ii) shall be available to defray in4 creases in the costs of the resources allo5 cated for the process for the review of ab6 breviated applications for generic new ani7 mal drugs (including increases in such 

8 costs for an additional number of full-time 

9 equivalent positions in the Department of 

10 Health and Human Services to be engaged 

11 in such process) over such costs, excluding 

12 costs paid from fees collected under this 

13 section, for fiscal year 2008 multiplied by 

14 the adjustment factor. 

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

16 be considered to have met the requirements of 

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

18 costs funded by appropriations and allocated for 

19 the process for the review of abbreviated appli20 cations for generic new animal drugs— 

21 ‘‘(i) are not more than 3 percent 

22 below the level specified in subparagraph 

23 (A)(ii); or 

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

25 the level specified in subparagraph (A)(ii), 
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1 and fees assessed for the fiscal year fol2 lowing the subsequent fiscal year are de3 creased by the amount in excess of 3 per4 cent by which such costs fell below the 

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

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

7 percent below the level specified in sub8 paragraph (A)(ii). 

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

10 Payment of fees authorized under this section 

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

12 fees, may be accepted by the Secretary in ac13 cordance with authority provided in advance in 

14 a prior year appropriations Act. 

15 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

16 There are authorized to be appropriated for fees 

17 under this section— 

18 ‘‘(A) $7,328,000 for fiscal year 2014; 

19 ‘‘(B) $6,944,000 for fiscal year 2015; 

20 ‘‘(C) $7,429,000 for fiscal year 2016; 

21 ‘‘(D) $7,936,000 for fiscal year 2017; and 

22 ‘‘(E) $8,467,000 for fiscal year 2018; 

23 as adjusted to reflect adjustments in the total fee 

24 revenues made under this section and changes in the 

25 total amounts collected by abbreviated application 
52 

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1 fees, generic new animal drug sponsor fees, and ge2 neric new animal drug product fees. 

3 ‘‘(4) OFFSET.—If the sum of the cumulative 

4 amount of fees collected under this section for the 

5 fiscal years 2014 through 2016 and the amount of 

6 fees estimated to be collected under this section for 

7 fiscal year 2017 exceeds the cumulative amount ap8 propriated under paragraph (3) for the fiscal years 

9 2014 through 2017, the excess amount shall be 

10 credited to the appropriation account of the Food 

11 and Drug Administration as provided in paragraph 

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

13 that would otherwise be authorized to be collected 

14 under this section pursuant to appropriation Acts 

15 for fiscal year 2018. 

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

17 where the Secretary does not receive payment of a fee as18 sessed under subsection (a) within 30 days after it is due, 

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

20 Government subject to subchapter II of chapter 37 of title 

21 31, United States Code. 

22 ‘‘(i) WRITTEN REQUESTS FOR WAIVERS, REDUC23 TIONS, AND REFUNDS.—To qualify for consideration for 

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

25 of any fee collected in accordance with subsection (a), a 
53 

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1 person shall submit to the Secretary a written request for 

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

3 after such fee is due. 

4 ‘‘(j) CONSTRUCTION.—This section may not be con5 strued to require that the number of full-time equivalent 

6 positions in the Department of Health and Human Serv7 ices, for officers, employees, and advisory committees not 

8 engaged in the process of the review of abbreviated appli9 cations for generic new animal drugs, be reduced to offset 

10 the number of officers, employees, and advisory commit11 tees so engaged. 

12 ‘‘(k) DEFINITIONS.—In this section and section 742: 

13 ‘‘(1) ABBREVIATED APPLICATION FOR A GE14 NERIC NEW ANIMAL DRUG.—The terms ‘abbreviated 

15 application for a generic new animal drug’ and ‘ab16 breviated application’ mean an abbreviated applica17 tion for the approval of any generic new animal drug 

18 submitted under section 512(b)(2). Such term does 

19 not include a supplemental abbreviated application 

20 for a generic new animal drug. 

21 ‘‘(2) ADJUSTMENT FACTOR.—The term ‘adjust22 ment factor’ applicable to a fiscal year is the Con23 sumer Price Index for all urban consumers (all 

24 items; United States city average) for October of the 

25 preceding fiscal year divided by— 
54 

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1 ‘‘(A) for purposes of subsection (f)(1), 

2 such Index for October 2002; and 

3 ‘‘(B) for purposes of subsection 

4 (g)(2)(A)(ii), such Index for October 2007. 

5 ‘‘(3) COSTS OF RESOURCES ALLOCATED FOR

6 THE PROCESS FOR THE REVIEW OF ABBREVIATED

7 APPLICATIONS FOR GENERIC NEW ANIMAL DRUGS.— 

8 The term ‘costs of resources allocated for the proc9 ess for the review of abbreviated applications for ge10 neric new animal drugs’ means the expenses in con11 nection with the process for the review of abbre12 viated applications for generic new animal drugs 

13 for— 

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

15 and Drug Administration, contractors of the 

16 Food and Drug Administration, advisory com17 mittees consulted with respect to the review of 

18 specific abbreviated applications, supplemental 

19 abbreviated applications, or investigational sub20 missions, and costs related to such officers, em21 ployees, committees, and contractors, including 

22 costs for travel, education, and recruitment and 

23 other personnel activities; 
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1 ‘‘(B) management of information, and the 

2 acquisition, maintenance, and repair of com3 puter resources; 

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

5 repair of facilities and acquisition, maintenance, 

6 and repair of fixtures, furniture, scientific 

7 equipment, and other necessary materials and 

8 supplies; and 

9 ‘‘(D) collecting fees under this section and 

10 accounting for resources allocated for the re11 view of abbreviated applications, supplemental 

12 abbreviated applications, and investigational 

13 submissions. 

14 ‘‘(4) FINAL DOSAGE FORM.—The term ‘final 

15 dosage form’ means, with respect to a generic new 

16 animal drug product, a finished dosage form which 

17 is approved for administration to an animal without 

18 substantial further manufacturing. Such term in19 cludes generic new animal drug products intended 

20 for mixing in animal feeds. 

21 ‘‘(5) GENERIC NEW ANIMAL DRUG.—The term 

22 ‘generic new animal drug’ means a new animal drug 

23 that is the subject of an abbreviated application. 

24 ‘‘(6) GENERIC NEW ANIMAL DRUG PRODUCT.— 

25 The term ‘generic new animal drug product’ means 
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1 each specific strength or potency of a particular ac2 tive ingredient or ingredients in final dosage form 

3 marketed by a particular manufacturer or dis4 tributor, which is uniquely identified by the labeler 

5 code and product code portions of the national drug 

6 code, and for which an abbreviated application for a 

7 generic new animal drug or a supplemental abbre8 viated application has been approved. 

9 ‘‘(7) GENERIC NEW ANIMAL DRUG SPONSOR.— 

10 The term ‘generic new animal drug sponsor’ means 

11 either an applicant named in an abbreviated applica12 tion for a generic new animal drug that has not been 

13 withdrawn by the applicant and for which approval 

14 has not been withdrawn by the Secretary, or a per15 son who has submitted an investigational submission 

16 for a generic new animal drug that has not been ter17 minated or otherwise rendered inactive by the Sec18 retary. 

19 ‘‘(8) INVESTIGATIONAL SUBMISSION FOR A GE20 NERIC NEW ANIMAL DRUG.—The terms ‘investiga21 tional submission for a generic new animal drug’ 

22 and ‘investigational submission’ mean— 

23 ‘‘(A) the filing of a claim for an investiga24 tional exemption under section 512(j) for a ge25 neric new animal drug intended to be the sub-
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1 ject of an abbreviated application or a supple2 mental abbreviated application; or 

3 ‘‘(B) the submission of information for the 

4 purpose of enabling the Secretary to evaluate 

5 the safety or effectiveness of a generic new ani6 mal drug in the event of the filing of an abbre7 viated application or supplemental abbreviated 

8 application for such drug. 

9 ‘‘(9) PERSON.—The term ‘person’ includes an 

10 affiliate thereof (as such term is defined in section 

11 735(11)). 

12 ‘‘(10) PROCESS FOR THE REVIEW OF ABBRE13 VIATED APPLICATIONS FOR GENERIC NEW ANIMAL

14 DRUGS.—The term ‘process for the review of abbre15 viated applications for generic new animal drugs’ 

16 means the following activities of the Secretary with 

17 respect to the review of abbreviated applications, 

18 supplemental abbreviated applications, and inves19 tigational submissions: 

20 ‘‘(A) The activities necessary for the re21 view of abbreviated applications, supplemental 

22 abbreviated applications, and investigational 

23 submissions. 

24 ‘‘(B) The issuance of action letters which 

25 approve abbreviated applications or supple-
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1 mental abbreviated applications or which set 

2 forth in detail the specific deficiencies in abbre3 viated applications, supplemental abbreviated 

4 applications, or investigational submissions and, 

5 where appropriate, the actions necessary to 

6 place such applications, supplemental applica7 tions, or submissions in condition for approval. 

8 ‘‘(C) The inspection of generic new animal 

9 drug establishments and other facilities under10 taken as part of the Secretary’s review of pend11 ing abbreviated applications, supplemental ab12 breviated applications, and investigational sub13 missions. 

14 ‘‘(D) Monitoring of research conducted in 

15 connection with the review of abbreviated appli16 cations, supplemental abbreviated applications, 

17 and investigational submissions. 

18 ‘‘(E) The development of regulations and 

19 policy related to the review of abbreviated appli20 cations, supplemental abbreviated applications, 

21 and investigational submissions. 

22 ‘‘(F) Development of standards for prod23 ucts subject to review. 

24 ‘‘(G) Meetings between the agency and the 

25 generic new animal drug sponsor. 
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1 ‘‘(H) Review of advertising and labeling 

2 prior to approval of an abbreviated application 

3 or supplemental abbreviated application, but 

4 not after such application has been approved. 

5 ‘‘(11) SUPPLEMENTAL ABBREVIATED APPLICA6 TION FOR GENERIC NEW ANIMAL DRUG.—The terms 

7 ‘supplemental abbreviated application for a generic 

8 new animal drug’ and ‘supplemental abbreviated ap9 plication’ mean a request to the Secretary to ap10 prove a change in an approved abbreviated applica11 tion.’’. 

12 SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS. 

13 Section 742 of the Federal Food, Drug, and Cosmetic 

14 Act (21 U.S.C. 379j–22) is amended to read as follows: 

15 ‘‘SEC. 742. REAUTHORIZATION; REPORTING REQUIRE16 MENTS. 

17 ‘‘(a) PERFORMANCE REPORTS.—Beginning with fis18 cal year 2014, not later than 120 days after the end of 

19 each fiscal year during which fees are collected under this 

20 part, the Secretary shall prepare and submit to the Com21 mittee on Health, Education, Labor, and Pensions of the 

22 Senate, and the Committee on Energy and Commerce of 

23 the House of Representatives a report concerning the 

24 progress of the Food and Drug Administration in achiev25 ing the goals identified in the letters described in section 
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1 201(b) of the Animal Generic Drug User Fee Amend2 ments of 2013 toward expediting the generic new animal 

3 drug development process and the review of abbreviated 

4 applications for generic new animal drugs, supplemental 

5 abbreviated applications for generic new animal drugs, 

6 and investigational submissions for generic new animal 

7 drugs during such fiscal year. 

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

9 2014, not later than 120 days after the end of each fiscal 

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

11 Secretary shall prepare and submit to Committee on 

12 Health, Education, Labor, and Pensions of the Senate and 

13 the Committee on Energy and Commerce of the House 

14 of Representatives a report on the implementation of the 

15 authority for such fees during such fiscal year and the 

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

17 collected during such fiscal year for which the report is 

18 made. 

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

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

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

22 Food and Drug Administration. 

23 ‘‘(d) REAUTHORIZATION.— 

24 ‘‘(1) CONSULTATION.—In developing rec25 ommendations to present to Congress with respect to 
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1 the goals, and plans for meeting the goals, for the 

2 process for the review of abbreviated applications for 

3 generic new animal drugs for the first 5 fiscal years 

4 after fiscal year 2018, and for the reauthorization of 

5 this part for such fiscal years, the Secretary shall 

6 consult with— 

7 ‘‘(A) the Committee on Energy and Com8 merce of the House of Representatives; 

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

10 Labor, and Pensions of the Senate; 

11 ‘‘(C) scientific and academic experts; 

12 ‘‘(D) veterinary professionals; 

13 ‘‘(E) representatives of patient and con14 sumer advocacy groups; and 

15 ‘‘(F) the regulated industry. 

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

17 negotiations with the regulated industry on the reau18 thorization of this part, the Secretary shall— 

19 ‘‘(A) publish a notice in the Federal Reg20 ister requesting public input on the reauthoriza21 tion; 

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

23 public may present its views on the reauthoriza24 tion, including specific suggestions for changes 

25 to the goals referred to in subsection (a); 
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1 ‘‘(C) provide a period of 30 days after the 

2 public meeting to obtain written comments from 

3 the public suggesting changes to this part; and 

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

5 and Drug Administration’s Internet Web site. 

6 ‘‘(3) PERIODIC CONSULTATION.—Not less fre7 quently than once every 4 months during negotia8 tions with the regulated industry, the Secretary shall 

9 hold discussions with representatives of veterinary, 

10 patient, and consumer advocacy groups to continue 

11 discussions of their views on the reauthorization and 

12 their suggestions for changes to this part as ex13 pressed under paragraph (2). 

14 ‘‘(4) PUBLIC REVIEW OF RECOMMENDA15 TIONS.—After negotiations with the regulated indus16 try, the Secretary shall— 

17 ‘‘(A) present the recommendations devel18 oped under paragraph (1) to the congressional 

19 committees specified in such paragraph; 

20 ‘‘(B) publish such recommendations in the 

21 Federal Register; 

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

23 the public to provide written comments on such 

24 recommendations; 
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1 ‘‘(D) hold a meeting at which the public 

2 may present its views on such recommenda3 tions; and 

4 ‘‘(E) after consideration of such public 

5 views and comments, revise such recommenda6 tions as necessary. 

7 ‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.— 

8 Not later than January 15, 2018, the Secretary 

9 shall transmit to Congress the revised recommenda10 tions under paragraph (4), a summary of the views 

11 and comments received under such paragraph, and 

12 any changes made to the recommendations in re13 sponse to such views and comments. 

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

15 ‘‘(A) PUBLIC AVAILABILITY.—Before pre16 senting the recommendations developed under 

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

18 Secretary shall make publicly available, on the 

19 Internet Web site of the Food and Drug Ad20 ministration, minutes of all negotiation meet21 ings conducted under this subsection between 

22 the Food and Drug Administration and the reg23 ulated industry. 

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

25 under subparagraph (A) shall summarize any 
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1 substantive proposal made by any party to the 

2 negotiations as well as significant controversies 

3 or differences of opinion during the negotiations 

4 and their resolution.’’. 

5 SEC. 204. SAVINGS CLAUSE. 

6 Notwithstanding the amendments made by this title, 

7 part 5 of subchapter C of chapter VII of the Federal Food, 

8 Drug, and Cosmetic Act, as in effect on the day before 

9 the date of enactment of this title, shall continue to be 

10 in effect with respect to abbreviated applications for a ge11 neric new animal drug and supplemental abbreviated ap12 plications for a generic new animal drug (as defined in 

13 such part as of such day) that on or after October 1, 2008, 

14 but before October 1, 2013, were accepted by the Food 

15 and Drug Administration for filing with respect to assess16 ing and collecting any fee required by such part for a fiscal 

17 year prior to fiscal year 2014. 

18 SEC. 205. EFFECTIVE DATE. 

19 The amendments made by this title shall take effect 

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

21 whichever is later, except that fees under part 5 of sub22 chapter C of chapter VII of the Federal Food, Drug, and 

23 Cosmetic Act, as amended by this title, shall be assessed 

24 for all abbreviated applications for a generic new animal 

25 drug and supplemental abbreviated applications for a ge-
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1 neric new animal drug received on or after October 1, 

2 2013, regardless of the date of enactment of this Act. 

3 SEC. 206. SUNSET DATES. 

4 (a) AUTHORIZATION.—Section 741 of the Federal 

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

6 cease to be effective October 1, 2018. 

7 (b) REPORTING REQUIREMENTS.—Section 742 of the 

8 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

9 22) shall cease to be effective January 31, 2019. 

10 (c) PREVIOUS SUNSET PROVISION.— 

11 (1) IN GENERAL.—Section 204 of the Animal 

12 Generic Drug User Fee Act of 2008 (Public Law 

13 110–316) is repealed. 

14 (2) CONFORMING AMENDMENT.—The Animal 

15 Generic Drug User Fee Act of 2008 (Public Law 

16 110–316) is amended in the table of contents in sec17 tion 1, by striking the item relating to section 204. 

Passed the Senate May 8, 2013. 

Attest: 

Secretary. 
113TH CONGRESS 

1ST SESSION S. 622 

AN ACT 

To amend the Federal Food, Drug, and Cosmetic 

new animal drugs and generic new animal drugs. Act to reauthorize user fee programs relating to