II 

Calendar No. 31 

113TH CONGRESS 

1ST SESSION S. 622 

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

fee programs relating to new animal drugs and generic new animal drugs. 

IN THE SENATE OF THE UNITED STATES 

MARCH 20, 2013 

Mr. HARKIN, from the Committee on Health, Education, Labor, and Pensions, 

reported the following original bill; which was read twice and placed on 

the calendar 

A BILL 

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, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Animal Drug and Ani5 mal Generic Drug User Fee Reauthorization Act of 

6 2013’’. 


rmajette on DSK2TPTVN1PROD with BILLS
2 

•S 622 PCS

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

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

3 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. 

4 (b) REFERENCES IN ACT.—Except as otherwise spec5 ified, amendments made by this Act to a section or other 

6 provision of law are amendments to such section or other 

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

8 (21 U.S.C. 301 et seq.). 

9 TITLE I—FEES RELATING TO 

10 ANIMAL DRUGS 

11 SEC. 101. SHORT TITLE; FINDING. 

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

13 ‘‘Animal Drug User Fee Amendments of 2013’’. 

14 (b) FINDING.—Congress finds that the fees author15 ized by the amendments made in this title will be dedi16 cated toward expediting the animal drug development 


rmajette on DSK2TPTVN1PROD with BILLS
3 

•S 622 PCS

1 process and the review of new and supplemental animal 

2 drug applications and investigational animal drug submis3 sions as set forth in the goals identified, for purposes of 

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

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

6 of Health and Human Services to the Chairman of the 

7 Committee on Energy and Commerce of the House of 

8 Representatives and the Chairman of the Committee on 

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

10 set forth in the Congressional Record. 

11 SEC. 102. DEFINITIONS. 

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

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

14 ‘‘SEC. 739. DEFINITIONS. 

15 ‘‘For purposes of this part: 

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

17 an application for approval of any new animal drug 

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

19 not include either a new animal drug application 

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

21 animal drug application. 

22 ‘‘(2) The term ‘supplemental animal drug appli23 cation’ means— 


rmajette on DSK2TPTVN1PROD with BILLS
4 

•S 622 PCS

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

2 a change in an animal drug application which 

3 has been approved; or 

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

5 a change to an application approved under sec6 tion 512(c)(2) for which data with respect to 

7 safety or effectiveness are required. 

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

9 each specific strength or potency of a particular ac10 tive ingredient or ingredients in final dosage form 

11 marketed by a particular manufacturer or dis12 tributor, which is uniquely identified by the labeler 

13 code and product code portions of the national drug 

14 code, and for which an animal drug application or 

15 a supplemental animal drug application has been ap16 proved. 

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

18 means a foreign or domestic place of business which 

19 is at one general physical location consisting of one 

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

21 each other, at which one or more animal drug prod22 ucts are manufactured in final dosage form. 

23 ‘‘(5) The term ‘investigational animal drug sub24 mission’ means— 


rmajette on DSK2TPTVN1PROD with BILLS
5 

•S 622 PCS

1 ‘‘(A) the filing of a claim for an investiga2 tional exemption under section 512(j) for a new 

3 animal drug intended to be the subject of an 

4 animal drug application or a supplemental ani5 mal drug application; or 

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

7 purpose of enabling the Secretary to evaluate 

8 the safety or effectiveness of an animal drug 

9 application or supplemental animal drug appli10 cation in the event of their filing. 

11 ‘‘(6) The term ‘animal drug sponsor’ means ei12 ther an applicant named in an animal drug applica13 tion that has not been withdrawn by the applicant 

14 and for which approval has not been withdrawn by 

15 the Secretary , or a person who has submitted an in16 vestigational animal drug submission that has not 

17 been terminated or otherwise rendered inactive by 

18 the Secretary. 

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

20 respect to an animal drug product, a finished dosage 

21 form which is approved for administration to an ani22 mal without substantial further manufacturing. Such 

23 term includes animal drug products intended for 

24 mixing in animal feeds. 


rmajette on DSK2TPTVN1PROD with BILLS
6 

•S 622 PCS

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

2 drug applications’ means the following activities of 

3 the Secretary with respect to the review of animal 

4 drug applications, supplemental animal drug applica5 tions, and investigational animal drug submissions: 

6 ‘‘(A) The activities necessary for the re7 view of animal drug applications, supplemental 

8 animal drug applications, and investigational 

9 animal drug submissions. 

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

11 approve animal drug applications or supple12 mental animal drug applications or which set 

13 forth in detail the specific deficiencies in animal 

14 drug applications, supplemental animal drug 

15 applications, or investigational animal drug sub16 missions and, where appropriate, the actions 

17 necessary to place such applications, supple18 ments or submissions in condition for approval. 

19 ‘‘(C) The inspection of animal drug estab20 lishments and other facilities undertaken as 

21 part of the Secretary’s review of pending animal 

22 drug applications, supplemental animal drug 

23 applications, and investigational animal drug 

24 submissions. 


rmajette on DSK2TPTVN1PROD with BILLS
7 

•S 622 PCS

1 ‘‘(D) Monitoring of research conducted in 

2 connection with the review of animal drug ap3 plications, supplemental animal drug applica4 tions, and investigational animal drug submis5 sions. 

6 ‘‘(E) The development of regulations and 

7 policy related to the review of animal drug ap8 plications, supplemental animal drug applica9 tions, and investigational animal drug submis10 sions. 

11 ‘‘(F) Development of standards for prod12 ucts subject to review. 

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

14 animal drug sponsor. 

15 ‘‘(H) Review of advertising and labeling 

16 prior to approval of an animal drug application 

17 or supplemental animal drug application, but 

18 not after such application has been approved. 

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

20 the process for the review of animal drug applica21 tions’ means the expenses in connection with the 

22 process for the review of animal drug applications 

23 for— 

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

25 and Drug Administration, contractors of the 


rmajette on DSK2TPTVN1PROD with BILLS
8 

•S 622 PCS

1 Food and Drug Administration, advisory com2 mittees consulted with respect to the review of 

3 specific animal drug applications, supplemental 

4 animal drug applications, or investigational ani5 mal drug submissions, and costs related to such 

6 officers, employees, committees, and contrac7 tors, including costs for travel, education, and 

8 recruitment and other personnel activities; 

9 ‘‘(B) management of information and the 

10 acquisition, maintenance, and repair of com11 puter resources; 

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

13 repair of facilities and acquisition, maintenance, 

14 and repair of fixtures, furniture, scientific 

15 equipment, and other necessary materials and 

16 supplies; and 

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

18 accounting for resources allocated for the re19 view of animal drug applications, supplemental 

20 animal drug applications, and investigational 

21 animal drug submissions. 

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

23 to a fiscal year refers to the formula set forth in sec24 tion 735(8) with the base or comparator month 

25 being October 2002. 


rmajette on DSK2TPTVN1PROD with BILLS
9 

•S 622 PCS

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

2 thereof. 

3 ‘‘(12) The term ‘affiliate’ refers to the defini4 tion set forth in section 735(11).’’. 

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

6 FEES. 

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

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

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

10 FEES. 

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

12 2004, the Secretary shall assess and collect fees in accord13 ance with this section as follows: 

14 ‘‘(1) ANIMAL DRUG APPLICATION AND SUPPLE15 MENT FEE.— 

16 ‘‘(A) IN GENERAL.—Each person that sub17 mits, on or after September 1, 2003, an animal 

18 drug application or a supplemental animal drug 

19 application shall be subject to a fee as follows: 

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

21 for an animal drug application, except an 

22 animal drug application subject to the cri23 teria set forth in section 512(d)(4). 

24 ‘‘(ii) A fee established in subsection 

25 (c), in an amount that is equal to 50 perVerDate Mar 15 2010 08:29 Mar 21, 2013 Jkt 029200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S622.PCS S622

rmajette on DSK2TPTVN1PROD with BILLS
10 

•S 622 PCS

1 cent of the amount of the fee under clause 

2 (i), for— 

3 ‘‘(I) a supplemental animal drug 

4 application for which safety or effec5 tiveness data are required; and 

6 ‘‘(II) an animal drug application 

7 subject to the criteria set forth in sec8 tion 512(d)(4). 

9 ‘‘(B) PAYMENT.—The fee required by sub10 paragraph (A) shall be due upon submission of 

11 the animal drug application or supplemental 

12 animal drug application. 

13 ‘‘(C) EXCEPTION FOR PREVIOUSLY FILED

14 APPLICATION OR SUPPLEMENT.—If an animal 

15 drug application or a supplemental animal drug 

16 application was submitted by a person that paid 

17 the fee for such application or supplement, was 

18 accepted for filing, and was not approved or 

19 was withdrawn (without a waiver or refund), 

20 the submission of an animal drug application or 

21 a supplemental animal drug application for the 

22 same product by the same person (or the per23 son’s licensee, assignee, or successor) shall not 

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


rmajette on DSK2TPTVN1PROD with BILLS
11 

•S 622 PCS

1 ‘‘(D) REFUND OF FEE IF APPLICATION RE2 FUSED FOR FILING.—The Secretary shall re3 fund 75 percent of the fee paid under subpara4 graph (B) for any animal drug application or 

5 supplemental animal drug application which is 

6 refused for filing. 

7 ‘‘(E) REFUND OF FEE IF APPLICATION

8 WITHDRAWN.—If an animal drug application or 

9 a supplemental animal drug application is with10 drawn after the application or supplement was 

11 filed, the Secretary may refund the fee or por12 tion of the fee paid under subparagraph (B) if 

13 no substantial work was performed on the ap14 plication or supplement after the application or 

15 supplement was filed. The Secretary shall have 

16 the sole discretion to refund the fee under this 

17 paragraph. A determination by the Secretary 

18 concerning a refund under this paragraph shall 

19 not be reviewable. 

20 ‘‘(2) ANIMAL DRUG PRODUCT FEE.— 

21 ‘‘(A) IN GENERAL.—Each person— 

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

23 an animal drug application or supple24 mental animal drug application for an aniVerDate Mar 15 2010 08:29 Mar 21, 2013 Jkt 029200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S622.PCS S622

rmajette on DSK2TPTVN1PROD with BILLS
12 

•S 622 PCS

1 mal drug product which has been sub2 mitted for listing under section 510; and 

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

4 had pending before the Secretary an ani5 mal drug application or supplemental ani6 mal drug application, 

7 shall pay for each such animal drug product the 

8 annual fee established in subsection (c). 

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

10 shall be payable for the fiscal year in which the 

11 animal drug product is first submitted for list12 ing under section 510, or is submitted for re13 listing under section 510 if the animal drug 

14 product has been withdrawn from listing and 

15 relisted. After such fee is paid for that fiscal 

16 year, such fee shall be due each subsequent fis17 cal year that the product remains listed, upon 

18 the later of— 

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

20 date of enactment of an appropriations Act 

21 providing for the collection and obligation 

22 of fees for such fiscal year under this sec23 tion; or 

24 ‘‘(ii) January 31 of each year. 


rmajette on DSK2TPTVN1PROD with BILLS
13 

•S 622 PCS

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

2 only once for each animal drug product for a 

3 fiscal year in which the fee is payable. 

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

5 ‘‘(A) IN GENERAL.—Each person— 

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

7 through an affiliate, an animal drug estab8 lishment; 

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

10 an animal drug application or supple11 mental animal drug application for an ani12 mal drug product which has been sub13 mitted for listing under section 510; and 

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

15 had pending before the Secretary an ani16 mal drug application or supplemental ani17 mal drug application, 

18 shall be assessed an annual establishment fee as 

19 established in subsection (c) for each animal 

20 drug establishment listed in its approved animal 

21 drug application as an establishment that man22 ufactures the animal drug product named in the 

23 application. 

24 ‘‘(B) PAYMENT; FEE DUE DATE.—The an25 nual establishment fee shall be assessed in each 


rmajette on DSK2TPTVN1PROD with BILLS
14 

•S 622 PCS

1 fiscal year in which the animal drug product 

2 named in the application is assessed a fee under 

3 paragraph (2) unless the animal drug establish4 ment listed in the application does not engage 

5 in the manufacture of the animal drug product 

6 during the fiscal year. The fee under this para7 graph for a fiscal year shall be due upon the 

8 later of— 

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

10 date of enactment of an appropriations Act 

11 providing for the collection and obligation 

12 of fees for such fiscal year under this sec13 tion; or 

14 ‘‘(ii) January 31 of each year. 

15 ‘‘(C) LIMITATION.— 

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

17 shall be assessed only one fee per fiscal 

18 year under this section, subject to clause 

19 (ii). 

20 ‘‘(ii) CERTAIN MANUFACTURERS.—If 

21 a single establishment manufactures both 

22 animal drug products and prescription 

23 drug products, as defined in section 

24 735(3), such establishment shall be as25 sessed both the animal drug establishment 


rmajette on DSK2TPTVN1PROD with BILLS
15 

•S 622 PCS

1 fee and the prescription drug establish2 ment fee, as set forth in section 736(a)(2), 

3 within a single fiscal year. 

4 ‘‘(4) ANIMAL DRUG SPONSOR FEE.— 

5 ‘‘(A) IN GENERAL.—Each person— 

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

7 animal drug sponsor within a fiscal year; 

8 and 

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

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

13 animal drug submission, 

14 shall be assessed an annual sponsor fee as es15 tablished under subsection (c). 

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

17 under this paragraph for a fiscal year shall be 

18 due upon the later of— 

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

20 date of enactment of an appropriations Act 

21 providing for the collection and obligation 

22 of fees for such fiscal year under this sec23 tion; or 

24 ‘‘(ii) January 31 of each year. 


rmajette on DSK2TPTVN1PROD with BILLS
16 

•S 622 PCS

1 ‘‘(C) LIMITATION.—Each animal drug 

2 sponsor shall pay only one such fee each fiscal 

3 year. 

4 ‘‘(b) FEE REVENUE AMOUNTS.— 

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

6 (d), (f), and (g)— 

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

8 under subsection (a) shall be established to gen9 erate a total revenue amount of $23,600,000; 

10 and 

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

12 2018, the fees required under subsection (a) 

13 shall be established to generate a total revenue 

14 amount of $21,600,000. 

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

16 amount determined for a fiscal year under para17 graph (1)— 

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

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

20 drug applications and supplements); 

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

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

23 drug products); 


rmajette on DSK2TPTVN1PROD with BILLS
17 

•S 622 PCS

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

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

3 drug establishments); and 

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

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

6 drug sponsors). 

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

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

9 shall establish, 60 days before the start of each fis10 cal year beginning after September 30, 2003, for 

11 that fiscal year, animal drug application fees, sup12 plemental animal drug application fees, animal drug 

13 sponsor fees, animal drug establishment fees, and 

14 animal drug product fees based on the revenue 

15 amounts established under subsection (b) and the 

16 adjustments provided under this subsection. 

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

18 2015 and subsequent fiscal years, the revenue 

19 amounts established in subsection (b) shall be ad20 justed by the Secretary by notice, published in the 

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

22 equal to the sum of— 

23 ‘‘(A) one; 

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

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


rmajette on DSK2TPTVN1PROD with BILLS
18 

•S 622 PCS

1 Food and Drug Administration, of all personnel 

2 compensation and benefits paid with respect to 

3 such positions for the first 3 of the preceding 

4 4 fiscal years for which data are available, mul5 tiplied by the average proportion of personnel 

6 compensation and benefits costs to total Food 

7 and Drug Administration costs for the first 3 

8 years of the preceding 4 fiscal years for which 

9 data are available; and 

10 ‘‘(C) the average annual percent change 

11 that occurred in the Consumer Price Index for 

12 urban consumers (Washington-Baltimore, DC13 MD-VA-WV; not seasonally adjusted; all items 

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

15 3 years of the preceding 4 years for which data 

16 are available multiplied by the average propor17 tion of all costs other than personnel compensa18 tion and benefits costs to total Food and Drug 

19 Administration costs for the first 3 years of the 

20 preceding 4 fiscal years for which data are 

21 available. 

22 The adjustment made each fiscal year under this 

23 paragraph shall be added on a compounded basis to 

24 the sum of all adjustments made each fiscal year 

25 after fiscal year 2014 under this paragraph. 


rmajette on DSK2TPTVN1PROD with BILLS
19 

•S 622 PCS

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

2 year 2015 and subsequent fiscal years, after the rev3 enue amounts established in subsection (b) are ad4 justed for inflation in accordance with paragraph 

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

6 for such fiscal year to reflect changes in the work7 load of the Secretary for the process for the review 

8 of animal drug applications. With respect to such 

9 adjustment— 

10 ‘‘(A) such adjustment shall be determined 

11 by the Secretary based on a weighted average 

12 of the change in the total number of animal 

13 drug applications, supplemental animal drug 

14 applications for which data with respect to safe15 ty or effectiveness are required, manufacturing 

16 supplemental animal drug applications, inves17 tigational animal drug study submissions, and 

18 investigational animal drug protocol submis19 sions submitted to the Secretary; 

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

21 Federal Register the fees resulting from such 

22 adjustment and the supporting methodologies; 

23 and 

24 ‘‘(C) under no circumstances shall such ad25 justment result in fee revenues for a fiscal year 


rmajette on DSK2TPTVN1PROD with BILLS
20 

•S 622 PCS

1 that are less than the fee revenues for that fis2 cal year established in subsection (b), as ad3 justed for inflation under paragraph (2). 

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

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

6 adjustments under this subsection, further increase 

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

8 necessary, to provide for up to 3 months of oper9 ating reserves of carryover user fees for the process 

10 for the review of animal drug applications for the 

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

12 Drug Administration has carryover balances for the 

13 process for the review of animal drug applications in 

14 excess of 3 months of such operating reserves, then 

15 this adjustment will not be made. If this adjustment 

16 is necessary, then the rationale for the amount of 

17 the increase shall be contained in the annual notice 

18 setting fees for fiscal year 2018. 

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

20 as adjusted under this subsection, for a fiscal year 

21 may not exceed the total costs for such fiscal year 

22 for the resources allocated for the process for the re23 view of animal drug applications. 

24 ‘‘(d) FEE WAIVER OR REDUCTION.— 


rmajette on DSK2TPTVN1PROD with BILLS
21 

•S 622 PCS

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

2 waiver from or a reduction of one or more fees as3 sessed under subsection (a) where the Secretary 

4 finds that— 

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

6 present a significant barrier to innovation be7 cause of limited resources available to such per8 son or other circumstances; 

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

10 will exceed the anticipated present and future 

11 costs incurred by the Secretary in conducting 

12 the process for the review of animal drug appli13 cations for such person; 

14 ‘‘(C) the animal drug application or sup15 plemental animal drug application is intended 

16 solely to provide for use of the animal drug 

17 in— 

18 ‘‘(i) a Type B medicated feed (as de19 fined in section 558.3(b)(3) of title 21, 

20 Code of Federal Regulations (or any suc21 cessor regulation)) intended for use in the 

22 manufacture of Type C free-choice medi23 cated feeds; or 

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

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


rmajette on DSK2TPTVN1PROD with BILLS
22 

•S 622 PCS

1 title 21, Code of Federal Regulations (or 

2 any successor regulation)); 

3 ‘‘(D) the animal drug application or sup4 plemental animal drug application is intended 

5 solely to provide for a minor use or minor spe6 cies indication; or 

7 ‘‘(E) the sponsor involved is a small busi8 ness submitting its first animal drug applica9 tion to the Secretary for review. 

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

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

12 standard costs. 

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

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

15 the term ‘small business’ means an entity that 

16 has fewer than 500 employees, including em17 ployees of affiliates. 

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

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

20 the application fee for the first animal drug ap21 plication that a small business or its affiliate 

22 submits to the Secretary for review. After a 

23 small business or its affiliate is granted such a 

24 waiver, the small business or its affiliate shall 

25 pay application fees for all subsequent animal 


rmajette on DSK2TPTVN1PROD with BILLS
23 

•S 622 PCS

1 drug applications and supplemental animal 

2 drug applications for which safety or effective3 ness data are required in the same manner as 

4 an entity that does not qualify as a small busi5 ness. 

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

7 require any person who applies for a waiver 

8 under paragraph (1)(E) to certify their quali9 fication for the waiver. The Secretary shall peri10 odically publish in the Federal Register a list of 

11 persons making such certifications. 

12 ‘‘(e) EFFECT OF FAILURE TO PAY FEES.—An ani13 mal drug application or supplemental animal drug applica14 tion submitted by a person subject to fees under sub15 section (a) shall be considered incomplete and shall not 

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

17 by such person have been paid. An investigational animal 

18 drug submission under section 739(5)(B) that is sub19 mitted by a person subject to fees under subsection (a) 

20 shall be considered incomplete and shall not be accepted 

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

22 person have been paid. The Secretary may discontinue re23 view of any animal drug application, supplemental animal 

24 drug application or investigational animal drug submission 

25 from a person if such person has not submitted for payVerDate Mar 15 2010 08:29 Mar 21, 2013 Jkt 029200 PO 00000 Frm 00023 Fmt 6652 Sfmt 6201 E:\BILLS\S622.PCS S622

rmajette on DSK2TPTVN1PROD with BILLS
24 

•S 622 PCS

1 ment all fees owed under this section by 30 days after 

2 the date upon which they are due. 

3 ‘‘(f) ASSESSMENT OF FEES.— 

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

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

6 fiscal year 2003 unless appropriations for salaries 

7 and expenses of the Food and Drug Administration 

8 for such fiscal year (excluding the amount of fees 

9 appropriated for such fiscal year) are equal to or 

10 greater than the amount of appropriations for the 

11 salaries and expenses of the Food and Drug Admin12 istration for the fiscal year 2003 (excluding the 

13 amount of fees appropriated for such fiscal year) 

14 multiplied by the adjustment factor applicable to the 

15 fiscal year involved. 

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

17 assess fees under subsection (a) during any portion 

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

19 a later date in such fiscal year the Secretary may as20 sess such fees, the Secretary may assess and collect 

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

22 animal drug applications, supplemental animal drug 

23 applications, investigational animal drug submis24 sions, animal drug sponsors, animal drug establish25 ments and animal drug products at any time in such 


rmajette on DSK2TPTVN1PROD with BILLS
25 

•S 622 PCS

1 fiscal year notwithstanding the provisions of sub2 section (a) relating to the date fees are 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 animal drug applications. 

17 ‘‘(2) COLLECTIONS AND APPROPRIATION

18 ACTS.— 

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

20 by this section— 

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

22 be collected and available in each fiscal 

23 year in an amount not to exceed the 

24 amount specified in appropriation Acts, or 


rmajette on DSK2TPTVN1PROD with BILLS
26 

•S 622 PCS

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 ani6 mal drug applications (including increases 

7 in such costs for an additional number of 

8 full-time equivalent positions in the De9 partment of Health and Human Services 

10 to be engaged in such process) over such 

11 costs, excluding costs paid from fees col12 lected under this section, for fiscal year 

13 2003 multiplied by the adjustment factor. 

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

15 be considered to have met the requirements of 

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

17 costs funded by appropriations and allocated for 

18 the process for the review of animal drug appli19 cations— 

20 ‘‘(i) are not more than 3 percent 

21 below the level specified in subparagraph 

22 (A)(ii); or 

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

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

25 and fees assessed for the fiscal year folVerDate Mar 15 2010 08:29 Mar 21, 2013 Jkt 029200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6201 E:\BILLS\S622.PCS S622

rmajette on DSK2TPTVN1PROD with BILLS
27 

•S 622 PCS

1 lowing the subsequent fiscal year are de2 creased by the amount in excess of 3 per3 cent by which such costs fell below the 

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

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

6 percent below the level specified in sub7 paragraph (A)(ii). 

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

9 Payment of fees authorized under this section 

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

11 fees, may be accepted by the Secretary in ac12 cordance with authority provided in advance in 

13 a prior year appropriations Act. 

14 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

15 For each of the fiscal years 2014 through 2018, 

16 there is authorized to be appropriated for fees under 

17 this section an amount equal to the total revenue 

18 amount determined under subsection (b) for the fis19 cal year, as adjusted or otherwise affected under 

20 subsection (c) and paragraph (4). 

21 ‘‘(4) OFFSET OF OVERCOLLECTIONS; RECOVERY

22 OF COLLECTION SHORTFALLS.— 

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

24 the sum of the cumulative amount of fees col25 lected under this section for fiscal years 2014 


rmajette on DSK2TPTVN1PROD with BILLS
28 

•S 622 PCS

1 through 2016 and the amount of fees estimated 

2 to be collected under this section for fiscal year 

3 2017 (including any increased fee collections at4 tributable to subparagraph (B)), exceeds the 

5 cumulative amount appropriated pursuant to 

6 paragraph (3) for the fiscal years 2014 through 

7 2017, the excess amount shall be credited to 

8 the appropriation account of the Food and 

9 Drug Administration as provided in paragraph 

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

11 fees that would otherwise be authorized to be 

12 collected under this section pursuant to appro13 priation Acts for fiscal year 2018. 

14 ‘‘(B) RECOVERY OF COLLECTION SHORT15 FALLS.— 

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

17 year 2016, the amount of fees otherwise 

18 authorized to be collected under this sec19 tion shall be increased by the amount, if 

20 any, by which the amount collected under 

21 this section and appropriated for fiscal 

22 year 2014 falls below the amount of fees 

23 authorized for fiscal year 2014 under para24 graph (3). 


rmajette on DSK2TPTVN1PROD with BILLS
29 

•S 622 PCS

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

2 year 2017, the amount of fees otherwise 

3 authorized to be collected under this sec4 tion shall be increased by the amount, if 

5 any, by which the amount collected under 

6 this section and appropriated for fiscal 

7 year 2015 falls below the amount of fees 

8 authorized for fiscal year 2015 under para9 graph (3). 

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

11 year 2018, the amount of fees otherwise 

12 authorized to be collected under this sec13 tion (including any reduction in the au14 thorized amount under subparagraph (A)), 

15 shall be increased by the cumulative 

16 amount, if any, by which the amount col17 lected under this section and appropriated 

18 for fiscal years 2016 and 2017 (including 

19 estimated collections for fiscal year 2017) 

20 falls below the cumulative amount of fees 

21 authorized under paragraph (3) for fiscal 

22 years 2016 and 2017. 

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

24 where the Secretary does not receive payment of a fee as25 sessed under subsection (a) within 30 days after it is due, 


rmajette on DSK2TPTVN1PROD with BILLS
30 

•S 622 PCS

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

2 Government subject to subchapter II of chapter 37 of title 

3 31, United States Code. 

4 ‘‘(i) WRITTEN REQUESTS FOR WAIVERS, REDUC5 TIONS, AND REFUNDS.—To qualify for consideration for 

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

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

8 person shall submit to the Secretary a written request for 

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

10 after such fee is due. 

11 ‘‘(j) CONSTRUCTION.—This section may not be con12 strued to require that the number of full-time equivalent 

13 positions in the Department of Health and Human Serv14 ices, for officers, employees, and advisory committees not 

15 engaged in the process of the review of animal drug appli16 cations, be reduced to offset the number of officers, em17 ployees, and advisory committees so engaged. 

18 ‘‘(k) ABBREVIATED NEW ANIMAL DRUG APPLICA19 TIONS.—The Secretary shall— 

20 ‘‘(1) to the extent practicable, segregate the re21 view of abbreviated new animal drug applications 

22 from the process for the review of animal drug appli23 cations; and 

24 ‘‘(2) adopt other administrative procedures to 

25 ensure that review times of abbreviated new animal 


rmajette on DSK2TPTVN1PROD with BILLS
31 

•S 622 PCS

1 drug applications do not increase from their current 

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

3 SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 

4 Section 740A of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 379j–13) is amended to read as fol6 lows: 

7 ‘‘SEC. 740A. REAUTHORIZATION; REPORTING REQUIRE8 MENTS. 

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

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

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

12 the Secretary shall prepare and submit to the Committee 

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

14 and the Committee on Energy and Commerce of the 

15 House of Representatives a report concerning the progress 

16 of the Food and Drug Administration in achieving the 

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

18 of the Animal Drug User Fee Amendments of 2013 to19 ward expediting the animal drug development process and 

20 the review of the new and supplemental animal drug appli21 cations and investigational animal drug submissions dur22 ing such fiscal year, the future plans of the Food and 

23 Drug Administration for meeting the goals, the review 

24 times for abbreviated new animal drug applications, and 

25 the administrative procedures adopted by the Food and 


rmajette on DSK2TPTVN1PROD with BILLS
32 

•S 622 PCS

1 Drug Administration to ensure that review times for ab2 breviated new animal drug applications are not increased 

3 from their current level due to activities under the user 

4 fee program. 

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

6 2014, not later than 120 days after the end of each fiscal 

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

8 Secretary shall prepare and submit to the Committee on 

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

10 the Committee on Energy and Commerce of the House 

11 of Representatives a report on the implementation of the 

12 authority for such fees during such fiscal year and the 

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

14 collected during such fiscal year for which the report is 

15 made. 

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

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

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

19 Food and Drug Administration. 

20 ‘‘(d) REAUTHORIZATION.— 

21 ‘‘(1) CONSULTATION.—In developing rec22 ommendations to present to the Congress with re23 spect to the goals, and plans for meeting the goals, 

24 for the process for the review of animal drug appli25 cations for the first 5 fiscal years after fiscal year 


rmajette on DSK2TPTVN1PROD with BILLS
33 

•S 622 PCS

1 2018, and for the reauthorization of this part for 

2 such fiscal years, the Secretary shall consult with— 

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

4 Labor, and Pensions of the Senate; 

5 ‘‘(B) the Committee on Energy and Com6 merce of the House of Representatives; 

7 ‘‘(C) scientific and academic experts; 

8 ‘‘(D) veterinary professionals; 

9 ‘‘(E) representatives of patient and con10 sumer advocacy groups; and 

11 ‘‘(F) the regulated industry. 

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

13 negotiations with the regulated industry on the reau14 thorization of this part, the Secretary shall— 

15 ‘‘(A) publish a notice in the Federal Reg16 ister requesting public input on the reauthoriza17 tion; 

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

19 public may present its views on the reauthoriza20 tion, including specific suggestions for changes 

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

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

23 public meeting to obtain written comments from 

24 the public suggesting changes to this part; and 


rmajette on DSK2TPTVN1PROD with BILLS
34 

•S 622 PCS

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

2 and Drug Administration’s Internet Web site. 

3 ‘‘(3) PERIODIC CONSULTATION.—Not less fre4 quently than once every 4 months during negotia5 tions with the regulated industry, the Secretary shall 

6 hold discussions with representatives of veterinary, 

7 patient, and consumer advocacy groups to continue 

8 discussions of their views on the reauthorization and 

9 their suggestions for changes to this part as ex10 pressed under paragraph (2). 

11 ‘‘(4) PUBLIC REVIEW OF RECOMMENDA12 TIONS.—After negotiations with the regulated indus13 try, the Secretary shall— 

14 ‘‘(A) present the recommendations devel15 oped under paragraph (1) to the Congressional 

16 committees specified in such paragraph; 

17 ‘‘(B) publish such recommendations in the 

18 Federal Register; 

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

20 the public to provide written comments on such 

21 recommendations; 

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

23 may present its views on such recommenda24 tions; and 


rmajette on DSK2TPTVN1PROD with BILLS
35 

•S 622 PCS

1 ‘‘(E) after consideration of such public 

2 views and comments, revise such recommenda3 tions as necessary. 

4 ‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.— 

5 Not later than January 15, 2018, the Secretary 

6 shall transmit to Congress the revised recommenda7 tions under paragraph (4) a summary of the views 

8 and comments received under such paragraph, and 

9 any changes made to the recommendations in re10 sponse to such views and comments. 

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

12 ‘‘(A) PUBLIC AVAILABILITY.—Before pre13 senting the recommendations developed under 

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

15 Secretary shall make publicly available, on the 

16 Internet Web site of the Food and Drug Ad17 ministration, minutes of all negotiation meet18 ings conducted under this subsection between 

19 the Food and Drug Administration and the reg20 ulated industry. 

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

22 under subparagraph (A) shall summarize any 

23 substantive proposal made by any party to the 

24 negotiations as well as significant controversies 


rmajette on DSK2TPTVN1PROD with BILLS
36 

•S 622 PCS

1 or differences of opinion during the negotiations 

2 and their resolution.’’. 

3 SEC. 105. SAVINGS CLAUSE. 

4 Notwithstanding the amendments made by this title, 

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

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

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

8 this title, shall continue to be in effect with respect to ani9 mal drug applications and supplemental animal drug ap10 plications (as defined in such part as of such day) that 

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

12 were accepted by the Food and Drug Administration for 

13 filing with respect to assessing and collecting any fee re14 quired by such part for a fiscal year prior to fiscal year 

15 2014. 

16 SEC. 106. EFFECTIVE DATE. 

17 The amendments made by this title shall take effect 

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

19 whichever is later, except that fees under part 4 of sub20 chapter C of chapter VII of the Federal Food, Drug, and 

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

22 for all animal drug applications and supplemental animal 

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

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


rmajette on DSK2TPTVN1PROD with BILLS
37 

•S 622 PCS

1 SEC. 107. SUNSET DATES. 

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

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

4 cease to be effective October 1, 2018. 

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

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

7 379j–13) shall cease to be effective January 31, 2019. 

8 (c) PREVIOUS SUNSET PROVISION.— 

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

10 Drug User Fee Amendments of 2008 (Public Law 

11 110–316) is repealed. 

12 (2) CONFORMING AMENDMENT.—The Animal 

13 Drug User Fee Amendments of 2008 (Public Law 

14 110–316) is amended in the table of contents in sec15 tion 1, by striking the item relating to section 108. 

16 (d) TECHNICAL CLARIFICATION.—Effective Novem17 ber 18, 2003, section 5 of the Animal Drug User Fee Act 

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

19 TITLE II—FEES RELATING TO 

20 GENERIC ANIMAL DRUGS 

21 SEC. 201. SHORT TITLE; FINDING. 

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

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

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

25 be dedicated toward expediting the generic new animal 

26 drug development process and the review of abbreviated 


rmajette on DSK2TPTVN1PROD with BILLS
38 

•S 622 PCS

1 applications for generic new animal drugs, supplemental 

2 abbreviated applications for generic new animal drugs, 

3 and investigational submissions for generic new animal 

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

5 the Secretary of Health and Human Services to the Chair6 man of the Committee on Energy and Commerce of the 

7 House of Representatives and the Chairman of the Com8 mittee on Health, Education, Labor, and Pensions of the 

9 Senate as set forth in the Congressional Record. 

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

11 ANIMAL DRUG FEES. 

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

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

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

15 ANIMAL DRUG FEES. 

16 ‘‘(a) TYPES OF FEES.—Beginning with respect to fis17 cal year 2009, the Secretary shall assess and collect fees 

18 in accordance with this section as follows: 

19 ‘‘(1) ABBREVIATED APPLICATION FEE.— 

20 ‘‘(A) IN GENERAL.—Each person that sub21 mits, on or after July 1, 2008, an abbreviated 

22 application for a generic new animal drug shall 

23 be subject to a fee as established in subsection 

24 (c) for such an application. 


rmajette on DSK2TPTVN1PROD with BILLS
39 

•S 622 PCS

1 ‘‘(B) PAYMENT.—The fee required by sub2 paragraph (A) shall be due upon submission of 

3 the abbreviated application. 

4 ‘‘(C) EXCEPTIONS.— 

5 ‘‘(i) PREVIOUSLY FILED APPLICA6 TION.—If an abbreviated application was 

7 submitted by a person that paid the fee for 

8 such application, was accepted for filing, 

9 and was not approved or was withdrawn 

10 (without a waiver or refund), the submis11 sion of an abbreviated application for the 

12 same product by the same person (or the 

13 person’s licensee, assignee, or successor) 

14 shall not be subject to a fee under sub15 paragraph (A). 

16 ‘‘(ii) CERTAIN ABBREVIATED APPLICA17 TIONS INVOLVING COMBINATION ANIMAL

18 DRUGS.—An abbreviated application which 

19 is subject to the criteria in section 

20 512(d)(4) and submitted on or after Octo21 ber 1, 2013 shall be subject to a fee equal 

22 to 50 percent of the amount of the abbre23 viated application fee established in sub24 section (c). 


rmajette on DSK2TPTVN1PROD with BILLS
40 

•S 622 PCS

1 ‘‘(D) REFUND OF FEE IF APPLICATION RE2 FUSED FOR FILING.—The Secretary shall re3 fund 75 percent of the fee paid under subpara4 graph (B) for any abbreviated application which 

5 is refused for filing. 

6 ‘‘(E) REFUND OF FEE IF APPLICATION

7 WITHDRAWN.—If an abbreviated application is 

8 withdrawn after the application was filed, the 

9 Secretary may refund the fee or portion of the 

10 fee paid under subparagraph (B) if no substan11 tial work was performed on the application 

12 after the application was filed. The Secretary 

13 shall have the sole discretion to refund the fee 

14 under this subparagraph. A determination by 

15 the Secretary concerning a refund under this 

16 subparagraph shall not be reviewable. 

17 ‘‘(2) GENERIC NEW ANIMAL DRUG PRODUCT

18 FEE.— 

19 ‘‘(A) IN GENERAL.—Each person— 

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

21 an abbreviated application or supplemental 

22 abbreviated application for a generic new 

23 animal drug product which has been sub24 mitted for listing under section 510; and 


rmajette on DSK2TPTVN1PROD with BILLS
41 

•S 622 PCS

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

2 had pending before the Secretary an abbre3 viated application or supplemental abbre4 viated application, 

5 shall pay for each such generic new animal 

6 drug product the annual fee established in sub7 section (c). 

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

9 shall be payable for the fiscal year in which the 

10 generic new animal drug product is first sub11 mitted for listing under section 510, or is sub12 mitted for relisting under section 510 if the ge13 neric new animal drug product has been with14 drawn from listing and relisted. After such fee 

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

16 each subsequent fiscal year that the product re17 mains listed, upon the later of— 

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

19 date of enactment of an appropriations Act 

20 providing for the collection and obligation 

21 of fees for such fiscal year under this sec22 tion; or 

23 ‘‘(ii) January 31 of each year. 

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

25 only once for each generic new animal drug 


rmajette on DSK2TPTVN1PROD with BILLS
42 

•S 622 PCS

1 product for a fiscal year in which the fee is pay2 able. 

3 ‘‘(3) GENERIC NEW ANIMAL DRUG SPONSOR

4 FEE.— 

5 ‘‘(A) IN GENERAL.—Each person— 

6 ‘‘(i) who meets the definition of a ge7 neric new animal drug sponsor within a 

8 fiscal year; and 

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

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

13 submission, 

14 shall be assessed an annual generic new animal 

15 drug sponsor fee as established under sub16 section (c). 

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

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

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

20 date of enactment of an appropriations Act 

21 providing for the collection and obligation 

22 of fees for such fiscal year under this sec23 tion; or 

24 ‘‘(ii) January 31 of each year. 


rmajette on DSK2TPTVN1PROD with BILLS
43 

•S 622 PCS

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

2 animal drug sponsor shall pay only 1 such fee 

3 each fiscal year, as follows: 

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

5 generic new animal drug sponsor fee pub6 lished for that fiscal year under subsection 

7 (c) for an applicant with more than 6 ap8 proved abbreviated applications. 

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

10 generic new animal drug sponsor fee pub11 lished for that fiscal year under subsection 

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

13 fewer than 7 approved abbreviated applica14 tions. 

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

16 generic new animal drug sponsor fee pub17 lished for that fiscal year under subsection 

18 (c) for an applicant with 1 or fewer ap19 proved abbreviated applications. 

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

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

22 be established to generate fee revenue amounts as follows: 

23 ‘‘(1) TOTAL FEE REVENUES FOR APPLICATION

24 FEES.—The total fee revenues to be collected in ab25 breviated application fees under subsection (a)(1) 


rmajette on DSK2TPTVN1PROD with BILLS
44 

•S 622 PCS

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

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

3 2016, $1,984,000 for fiscal year 2017, and 

4 $2,117,000 for fiscal year 2018. 

5 ‘‘(2) TOTAL FEE REVENUES FOR PRODUCT

6 FEES.—The total fee revenues to be collected in ge7 neric new animal drug product fees under subsection 

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

9 $2,604,000 for fiscal year 2015, $2,786,000 for fis10 cal year 2016, $2,976,000 for fiscal year 2017, and 

11 $3,175,000 for fiscal year 2018. 

12 ‘‘(3) TOTAL FEE REVENUES FOR SPONSOR

13 FEES.—The total fee revenues to be collected in ge14 neric new animal drug sponsor fees under subsection 

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

16 $2,604,000 for fiscal year 2015, $2,786,000 for fis17 cal year 2016, $2,976,000 for fiscal year 2017, and 

18 $3,175,000 for fiscal year 2018. 

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

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

21 shall establish, 60 days before the start of each fis22 cal year beginning after September 30, 2008, for 

23 that fiscal year, abbreviated application fees, generic 

24 new animal drug sponsor fees, and generic new ani25 mal drug product fees, based on the revenue 


rmajette on DSK2TPTVN1PROD with BILLS
45 

•S 622 PCS

1 amounts established under subsection (b) and the 

2 adjustments provided under this subsection. 

3 ‘‘(2) WORKLOAD ADJUSTMENT.—The fee reve4 nues shall be adjusted each fiscal year after fiscal 

5 year 2014 to reflect changes in review workload. 

6 With respect to such adjustment: 

7 ‘‘(A) This adjustment shall be determined 

8 by the Secretary based on a weighted average 

9 of the change in the total number of abbre10 viated applications for generic new animal 

11 drugs, manufacturing supplemental abbreviated 

12 applications for generic new animal drugs, in13 vestigational generic new animal drug study 

14 submissions, and investigational generic new 

15 animal drug protocol submissions submitted to 

16 the Secretary. The Secretary shall publish in 

17 the Federal Register the fees resulting from 

18 this adjustment and the supporting methodolo19 gies. 

20 ‘‘(B) Under no circumstances shall this 

21 workload adjustment result in fee revenues for 

22 a fiscal year that are less than the fee revenues 

23 for that fiscal year established in subsection 

24 (b). 


rmajette on DSK2TPTVN1PROD with BILLS
46 

•S 622 PCS

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

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

3 adjustments under this subsection, further increase 

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

5 necessary, to provide for up to 3 months of oper6 ating reserves of carryover user fees for the process 

7 for the review of abbreviated applications for generic 

8 new animal drugs for the first 3 months of fiscal 

9 year 2019. If the Food and Drug Administration 

10 has carryover balances for the process for the review 

11 of abbreviated applications for generic new animal 

12 drugs in excess of 3 months of such operating re13 serves, then this adjustment shall not be made. If 

14 this adjustment is necessary, then the rationale for 

15 the amount of the increase shall be contained in the 

16 annual notice setting fees for fiscal year 2018. 

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

18 as adjusted under this subsection, for a fiscal year 

19 may not exceed the total costs for such fiscal year 

20 for the resources allocated for the process for the re21 view of abbreviated applications for generic new ani22 mal drugs. 

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

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

25 assessed under subsection (a) where the Secretary finds 


rmajette on DSK2TPTVN1PROD with BILLS
47 

•S 622 PCS

1 that the generic new animal drug is intended solely to pro2 vide for a minor use or minor species indication. 

3 ‘‘(e) EFFECT OF FAILURE TO PAY FEES.—An abbre4 viated application for a generic new animal drug sub5 mitted by a person subject to fees under subsection (a) 

6 shall be considered incomplete and shall not be accepted 

7 for filing by the Secretary until all fees owed by such per8 son have been paid. An investigational submission for a 

9 generic new animal drug that is submitted by a person 

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

11 incomplete and shall not be accepted for review by the Sec12 retary until all fees owed by such person have been paid. 

13 The Secretary may discontinue review of any abbreviated 

14 application for a generic new animal drug, supplemental 

15 abbreviated application for a generic new animal drug, or 

16 investigational submission for a generic new animal drug 

17 from a person if such person has not submitted for pay18 ment all fees owed under this section by 30 days after 

19 the date upon which they are due. 

20 ‘‘(f) ASSESSMENT OF FEES.— 

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

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

23 fiscal year 2008 unless appropriations for salaries 

24 and expenses of the Food and Drug Administration 

25 for such fiscal year (excluding the amount of fees 


rmajette on DSK2TPTVN1PROD with BILLS
48 

•S 622 PCS

1 appropriated for such fiscal year) are equal to or 

2 greater than the amount of appropriations for the 

3 salaries and expenses of the Food and Drug Admin4 istration for the fiscal year 2003 (excluding the 

5 amount of fees appropriated for such fiscal year) 

6 multiplied by the adjustment factor applicable to the 

7 fiscal year involved. 

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

9 assess fees under subsection (a) during any portion 

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

11 a later date in such fiscal year the Secretary may as12 sess such fees, the Secretary may assess and collect 

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

14 abbreviated applications, generic new animal drug 

15 sponsors, and generic new animal drug products at 

16 any time in such fiscal year notwithstanding the pro17 visions of subsection (a) relating to the date fees are 

18 to be paid. 

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

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

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

22 collected and available for obligation only to the ex23 tent and in the amount provided in advance in ap24 propriations Acts. Such fees are authorized to be ap25 propriated to remain available until expended. Such 


rmajette on DSK2TPTVN1PROD with BILLS
49 

•S 622 PCS

1 sums as may be necessary may be transferred from 

2 the Food and Drug Administration salaries and ex3 penses appropriation account without fiscal year lim4 itation to such appropriation account for salary and 

5 expenses with such fiscal year limitation. The sums 

6 transferred shall be available solely for the process 

7 for the review of abbreviated applications for generic 

8 new animal drugs. 

9 ‘‘(2) COLLECTIONS AND APPROPRIATION

10 ACTS.— 

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

12 by this section— 

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

14 be collected and available in each fiscal 

15 year in an amount not to exceed the 

16 amount specified in appropriation Acts, or 

17 otherwise made available for obligation for 

18 such fiscal year; and 

19 ‘‘(ii) shall be available to defray in20 creases in the costs of the resources allo21 cated for the process for the review of ab22 breviated applications for generic new ani23 mal drugs (including increases in such 

24 costs for an additional number of full-time 

25 equivalent positions in the Department of 


rmajette on DSK2TPTVN1PROD with BILLS
50 

•S 622 PCS

1 Health and Human Services to be engaged 

2 in such process) over such costs, excluding 

3 costs paid from fees collected under this 

4 section, for fiscal year 2008 multiplied by 

5 the adjustment factor. 

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

7 be considered to have met the requirements of 

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

9 costs funded by appropriations and allocated for 

10 the process for the review of abbreviated appli11 cations for generic new animal drugs— 

12 ‘‘(i) are not more than 3 percent 

13 below the level specified in subparagraph 

14 (A)(ii); or 

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

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

17 and fees assessed for the fiscal year fol18 lowing the subsequent fiscal year are de19 creased by the amount in excess of 3 per20 cent by which such costs fell below the 

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

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

23 percent below the level specified in sub24 paragraph (A)(ii). 


rmajette on DSK2TPTVN1PROD with BILLS
51 

•S 622 PCS

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

2 Payment of fees authorized under this section 

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

4 fees, may be accepted by the Secretary in ac5 cordance with authority provided in advance in 

6 a prior year appropriations Act. 

7 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

8 There are authorized to be appropriated for fees 

9 under this section— 

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

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

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

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

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

15 as adjusted to reflect adjustments in the total fee 

16 revenues made under this section and changes in the 

17 total amounts collected by abbreviated application 

18 fees, generic new animal drug sponsor fees, and ge19 neric new animal drug product fees. 

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

21 amount of fees collected under this section for the 

22 fiscal years 2014 through 2016 and the amount of 

23 fees estimated to be collected under this section for 

24 fiscal year 2017 exceeds the cumulative amount ap25 propriated under paragraph (3) for the fiscal years 


rmajette on DSK2TPTVN1PROD with BILLS
52 

•S 622 PCS

1 2014 through 2017, the excess amount shall be 

2 credited to the appropriation account of the Food 

3 and Drug Administration as provided in paragraph 

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

5 that would otherwise be authorized to be collected 

6 under this section pursuant to appropriation Acts 

7 for fiscal year 2018. 

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

9 where the Secretary does not receive payment of a fee as10 sessed under subsection (a) within 30 days after it is due, 

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

12 Government subject to subchapter II of chapter 37 of title 

13 31, United States Code. 

14 ‘‘(i) WRITTEN REQUESTS FOR WAIVERS, REDUC15 TIONS, AND REFUNDS.—To qualify for consideration for 

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

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

18 person shall submit to the Secretary a written request for 

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

20 after such fee is due. 

21 ‘‘(j) CONSTRUCTION.—This section may not be con22 strued to require that the number of full-time equivalent 

23 positions in the Department of Health and Human Serv24 ices, for officers, employees, and advisory committees not 

25 engaged in the process of the review of abbreviated appliVerDate Mar 15 2010 08:29 Mar 21, 2013 Jkt 029200 PO 00000 Frm 00052 Fmt 6652 Sfmt 6201 E:\BILLS\S622.PCS S622

rmajette on DSK2TPTVN1PROD with BILLS
53 

•S 622 PCS

1 cations for generic new animal drugs, be reduced to offset 

2 the number of officers, employees, and advisory commit3 tees so engaged. 

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

5 ‘‘(1) ABBREVIATED APPLICATION FOR A GE6 NERIC NEW ANIMAL DRUG.—The terms ‘abbreviated 

7 application for a generic new animal drug’ and ‘ab8 breviated application’ mean an abbreviated applica9 tion for the approval of any generic new animal drug 

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

11 not include a supplemental abbreviated application 

12 for a generic new animal drug. 

13 ‘‘(2) ADJUSTMENT FACTOR.—The term ‘adjust14 ment factor’ applicable to a fiscal year is the Con15 sumer Price Index for all urban consumers (all 

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

17 preceding fiscal year divided by— 

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

19 such Index for October 2002; and 

20 ‘‘(B) for purposes of subsection 

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

22 ‘‘(3) COSTS OF RESOURCES ALLOCATED FOR

23 THE PROCESS FOR THE REVIEW OF ABBREVIATED

24 APPLICATIONS FOR GENERIC NEW ANIMAL DRUGS.— 

25 The term ‘costs of resources allocated for the procVerDate Mar 15 2010 08:29 Mar 21, 2013 Jkt 029200 PO 00000 Frm 00053 Fmt 6652 Sfmt 6201 E:\BILLS\S622.PCS S622

rmajette on DSK2TPTVN1PROD with BILLS
54 

•S 622 PCS

1 ess for the review of abbreviated applications for ge2 neric new animal drugs’ means the expenses in con3 nection with the process for the review of abbre4 viated applications for generic new animal drugs 

5 for— 

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

7 and Drug Administration, contractors of the 

8 Food and Drug Administration, advisory com9 mittees consulted with respect to the review of 

10 specific abbreviated applications, supplemental 

11 abbreviated applications, or investigational sub12 missions, and costs related to such officers, em13 ployees, committees, and contractors, including 

14 costs for travel, education, and recruitment and 

15 other personnel activities; 

16 ‘‘(B) management of information, and the 

17 acquisition, maintenance, and repair of com18 puter resources; 

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

20 repair of facilities and acquisition, maintenance, 

21 and repair of fixtures, furniture, scientific 

22 equipment, and other necessary materials and 

23 supplies; and 

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

25 accounting for resources allocated for the reVerDate Mar 15 2010 08:29 Mar 21, 2013 Jkt 029200 PO 00000 Frm 00054 Fmt 6652 Sfmt 6201 E:\BILLS\S622.PCS S622

rmajette on DSK2TPTVN1PROD with BILLS
55 

•S 622 PCS

1 view of abbreviated applications, supplemental 

2 abbreviated applications, and investigational 

3 submissions. 

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

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

6 animal drug product, a finished dosage form which 

7 is approved for administration to an animal without 

8 substantial further manufacturing. Such term in9 cludes generic new animal drug products intended 

10 for mixing in animal feeds. 

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

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

13 that is the subject of an abbreviated application. 

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

15 The term ‘generic new animal drug product’ means 

16 each specific strength or potency of a particular ac17 tive ingredient or ingredients in final dosage form 

18 marketed by a particular manufacturer or dis19 tributor, which is uniquely identified by the labeler 

20 code and product code portions of the national drug 

21 code, and for which an abbreviated application for a 

22 generic new animal drug or a supplemental abbre23 viated application has been approved. 

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

25 The term ‘generic new animal drug sponsor’ means 


rmajette on DSK2TPTVN1PROD with BILLS
56 

•S 622 PCS

1 either an applicant named in an abbreviated applica2 tion for a generic new animal drug that has not been 

3 withdrawn by the applicant and for which approval 

4 has not been withdrawn by the Secretary, or a per5 son who has submitted an investigational submission 

6 for a generic new animal drug that has not been ter7 minated or otherwise rendered inactive by the Sec8 retary. 

9 ‘‘(8) INVESTIGATIONAL SUBMISSION FOR A GE10 NERIC NEW ANIMAL DRUG.—The terms ‘investiga11 tional submission for a generic new animal drug’ 

12 and ‘investigational submission’ mean— 

13 ‘‘(A) the filing of a claim for an investiga14 tional exemption under section 512(j) for a ge15 neric new animal drug intended to be the sub16 ject of an abbreviated application or a supple17 mental abbreviated application; or 

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

19 purpose of enabling the Secretary to evaluate 

20 the safety or effectiveness of a generic new ani21 mal drug in the event of the filing of an abbre22 viated application or supplemental abbreviated 

23 application for such drug. 


rmajette on DSK2TPTVN1PROD with BILLS
57 

•S 622 PCS

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

2 affiliate thereof (as such term is defined in section 

3 735(11)). 

4 ‘‘(10) PROCESS FOR THE REVIEW OF ABBRE5 VIATED APPLICATIONS FOR GENERIC NEW ANIMAL

6 DRUGS.—The term ‘process for the review of abbre7 viated applications for generic new animal drugs’ 

8 means the following activities of the Secretary with 

9 respect to the review of abbreviated applications, 

10 supplemental abbreviated applications, and inves11 tigational submissions: 

12 ‘‘(A) The activities necessary for the re13 view of abbreviated applications, supplemental 

14 abbreviated applications, and investigational 

15 submissions. 

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

17 approve abbreviated applications or supple18 mental abbreviated applications or which set 

19 forth in detail the specific deficiencies in abbre20 viated applications, supplemental abbreviated 

21 applications, or investigational submissions and, 

22 where appropriate, the actions necessary to 

23 place such applications, supplemental applica24 tions, or submissions in condition for approval. 


rmajette on DSK2TPTVN1PROD with BILLS
58 

•S 622 PCS

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

2 drug establishments and other facilities under3 taken as part of the Secretary’s review of pend4 ing abbreviated applications, supplemental ab5 breviated applications, and investigational sub6 missions. 

7 ‘‘(D) Monitoring of research conducted in 

8 connection with the review of abbreviated appli9 cations, supplemental abbreviated applications, 

10 and investigational submissions. 

11 ‘‘(E) The development of regulations and 

12 policy related to the review of abbreviated appli13 cations, supplemental abbreviated applications, 

14 and investigational submissions. 

15 ‘‘(F) Development of standards for prod16 ucts subject to review. 

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

18 generic new animal drug sponsor. 

19 ‘‘(H) Review of advertising and labeling 

20 prior to approval of an abbreviated application 

21 or supplemental abbreviated application, but 

22 not after such application has been approved. 

23 ‘‘(11) SUPPLEMENTAL ABBREVIATED APPLICA24 TION FOR GENERIC NEW ANIMAL DRUG.—The terms 

25 ‘supplemental abbreviated application for a generic 


rmajette on DSK2TPTVN1PROD with BILLS
59 

•S 622 PCS

1 new animal drug’ and ‘supplemental abbreviated ap2 plication’ mean a request to the Secretary to ap3 prove a change in an approved abbreviated applica4 tion.’’. 

5 SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS. 

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

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

8 ‘‘SEC. 742. REAUTHORIZATION; REPORTING REQUIRE9 MENTS. 

10 ‘‘(a) PERFORMANCE REPORTS.—Beginning with fis11 cal year 2014, not later than 120 days after the end of 

12 each fiscal year during which fees are collected under this 

13 part, the Secretary shall prepare and submit to the Com14 mittee on Health, Education, Labor, and Pensions of the 

15 Senate, and the Committee on Energy and Commerce of 

16 the House of Representatives a report concerning the 

17 progress of the Food and Drug Administration in achiev18 ing the goals identified in the letters described in section 

19 201(b) of the Animal Generic Drug User Fee Amend20 ments of 2013 toward expediting the generic new animal 

21 drug development process and the review of abbreviated 

22 applications for generic new animal drugs, supplemental 

23 abbreviated applications for generic new animal drugs, 

24 and investigational submissions for generic new animal 

25 drugs during such fiscal year. 


rmajette on DSK2TPTVN1PROD with BILLS
60 

•S 622 PCS

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 Committee on 

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

6 the Committee on Energy and Commerce of the House 

7 of Representatives a report on the implementation of the 

8 authority for such fees during such fiscal year and the 

9 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 Congress with respect to 

19 the goals, and plans for meeting the goals, for the 

20 process for the review of abbreviated applications for 

21 generic new animal drugs for the first 5 fiscal years 

22 after fiscal year 2018, and for the reauthorization of 

23 this part for such fiscal years, the Secretary shall 

24 consult with— 


rmajette on DSK2TPTVN1PROD with BILLS
61 

•S 622 PCS

1 ‘‘(A) the Committee on Energy and Com2 merce of the House of Representatives; 

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

4 Labor, and Pensions of the Senate; 

5 ‘‘(C) scientific and academic experts; 

6 ‘‘(D) veterinary professionals; 

7 ‘‘(E) representatives of patient and con8 sumer advocacy groups; and 

9 ‘‘(F) the regulated industry. 

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

11 negotiations with the regulated industry on the reau12 thorization of this part, the Secretary shall— 

13 ‘‘(A) publish a notice in the Federal Reg14 ister requesting public input on the reauthoriza15 tion; 

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

17 public may present its views on the reauthoriza18 tion, including specific suggestions for changes 

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

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

21 public meeting to obtain written comments from 

22 the public suggesting changes to this part; and 

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

24 and Drug Administration’s Internet Web site. 


rmajette on DSK2TPTVN1PROD with BILLS
62 

•S 622 PCS

1 ‘‘(3) PERIODIC CONSULTATION.—Not less fre2 quently than once every 4 months during negotia3 tions with the regulated industry, the Secretary shall 

4 hold discussions with representatives of veterinary, 

5 patient, and consumer advocacy groups to continue 

6 discussions of their views on the reauthorization and 

7 their suggestions for changes to this part as ex8 pressed under paragraph (2). 

9 ‘‘(4) PUBLIC REVIEW OF RECOMMENDA10 TIONS.—After negotiations with the regulated indus11 try, the Secretary shall— 

12 ‘‘(A) present the recommendations devel13 oped under paragraph (1) to the congressional 

14 committees specified in such paragraph; 

15 ‘‘(B) publish such recommendations in the 

16 Federal Register; 

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

18 the public to provide written comments on such 

19 recommendations; 

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

21 may present its views on such recommenda22 tions; and 

23 ‘‘(E) after consideration of such public 

24 views and comments, revise such recommenda25 tions as necessary. 


rmajette on DSK2TPTVN1PROD with BILLS
63 

•S 622 PCS

1 ‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.— 

2 Not later than January 15, 2018, the Secretary 

3 shall transmit to Congress the revised recommenda4 tions under paragraph (4), a summary of the views 

5 and comments received under such paragraph, and 

6 any changes made to the recommendations in re7 sponse to such views and comments. 

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

9 ‘‘(A) PUBLIC AVAILABILITY.—Before pre10 senting the recommendations developed under 

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

12 Secretary shall make publicly available, on the 

13 Internet Web site of the Food and Drug Ad14 ministration, minutes of all negotiation meet15 ings conducted under this subsection between 

16 the Food and Drug Administration and the reg17 ulated industry. 

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

19 under subparagraph (A) shall summarize any 

20 substantive proposal made by any party to the 

21 negotiations as well as significant controversies 

22 or differences of opinion during the negotiations 

23 and their resolution.’’. 


rmajette on DSK2TPTVN1PROD with BILLS
64 

•S 622 PCS

1 SEC. 204. SAVINGS CLAUSE. 

2 Notwithstanding the amendments made by this title, 

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

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

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

6 in effect with respect to abbreviated applications for a ge7 neric new animal drug and supplemental abbreviated ap8 plications for a generic new animal drug (as defined in 

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

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

11 and Drug Administration for filing with respect to assess12 ing and collecting any fee required by such part for a fiscal 

13 year prior to fiscal year 2014. 

14 SEC. 205. EFFECTIVE DATE. 

15 The amendments made by this title shall take effect 

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

17 whichever is later, except that fees under part 5 of sub18 chapter C of chapter VII of the Federal Food, Drug, and 

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

20 for all abbreviated applications for a generic new animal 

21 drug and supplemental abbreviated applications for a ge22 neric new animal drug received on or after October 1, 

23 2013, regardless of the date of enactment of this Act. 


rmajette on DSK2TPTVN1PROD with BILLS
65 

•S 622 PCS

1 SEC. 206. SUNSET DATES. 

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

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

4 cease to be effective October 1, 2018. 

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

6 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j7 22) shall cease to be effective January 31, 2019. 

8 (c) PREVIOUS SUNSET PROVISION.— 

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

10 Generic Drug User Fee Act of 2008 (Public Law 

11 110–316) is repealed. 

12 (2) CONFORMING AMENDMENT.—The Animal 

13 Generic Drug User Fee Act of 2008 (Public Law 

14 110–316) is amended in the table of contents in sec15 tion 1, by striking the item relating to section 204. 


rmajette on DSK2TPTVN1PROD with BILLS
Calendar No. 31 

113TH CONGRESS 

1ST SESSION S. 622 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

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

MARCH 20, 2013 

Read twice and placed on the calendar 


rmajette on DSK2TPTVN1PROD with BILLS