IB 

Union Calendar No. 135 

113TH CONGRESS 

1ST SESSION H. R. 1407 

[Report No. 113–188] 

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

fee programs relating to new animal drugs. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 9, 2013 

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

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

AUGUST 2, 2013 

Reported with amendments, committed to the Committee of the Whole House 

on the State of the Union, and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on April 9, 2013] 


sroberts on DSK5SPTVN1PROD with BILLS
2 

•HR 1407 RH

A BILL 

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

reauthorize user fee programs relating to new animal drugs. 


sroberts on DSK5SPTVN1PROD with BILLS
3 

•HR 1407 RH

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

3 SECTION 1. TABLE OF CONTENTS. 

Sec. 1. Table of Contents. 

TITLE I—ANIMAL DRUG USER FEE AMENDMENTS 

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—ANIMAL GENERIC DRUG USER FEE AMENDMENTS 

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 TITLE I—ANIMAL DRUG USER 

5 FEE AMENDMENTS 

6 SEC. 101. SHORT TITLE; FINDING. 

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

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

9 (b) FINDING.—Congress finds that the fees authorized 

10 by the amendments made in this title will be dedicated to11 ward expediting the animal drug development process and 

12 the review of new and supplemental animal drug applica13 tions and investigational animal drug submissions as set 

14 forth in the goals identified, for purposes of part 4 of sub15 chapter C of chapter VII of the Federal Food, Drug, and 

16 Cosmetic Act, in the letters from the Secretary of Health 


sroberts on DSK5SPTVN1PROD with BILLS
4 

•HR 1407 RH

1 and Human Services to the Chairman of the Committee on 

2 Energy and Commerce of the House of Representatives and 

3 the Chairman of the Committee on Health, Education, 

4 Labor, and Pensions of the Senate as set forth in the Con5 gressional Record. 

6 SEC. 102. DEFINITIONS. 

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

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

9 ‘‘SEC. 739. DEFINITIONS. 

10 ‘‘For purposes of this part: 

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

12 an application for approval of any new animal drug 

13 submitted under section 512(b)(1). Such term does not 

14 include either a new animal drug application sub15 mitted under section 512(b)(2) or a supplemental ani16 mal drug application. 

17 ‘‘(2) The term ‘supplemental animal drug appli18 cation’ means— 

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

20 a change in an animal drug application which 

21 has been approved; or 

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

23 a change to an application approved under sec24 tion 512(c)(2) for which data with respect to 

25 safety or effectiveness are required. 


sroberts on DSK5SPTVN1PROD with BILLS
5 

•HR 1407 RH

1 ‘‘(3) The term ‘animal drug product’ means each 

2 specific strength or potency of a particular active in3 gredient or ingredients in final dosage form marketed 

4 by a particular manufacturer or distributor, which is 

5 uniquely identified by the labeler code and product 

6 code portions of the national drug code, and for which 

7 an animal drug application or a supplemental ani8 mal drug application has been approved. 

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

10 means a foreign or domestic place of business which 

11 is at one general physical location consisting of one 

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

13 each other, at which one or more animal drug prod14 ucts are manufactured in final dosage form. 

15 ‘‘(5) The term ‘investigational animal drug sub16 mission’ means— 

17 ‘‘(A) the filing of a claim for an investiga18 tional exemption under section 512(j) for a new 

19 animal drug intended to be the subject of an ani20 mal drug application or a supplemental animal 

21 drug application; or 

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

23 purpose of enabling the Secretary to evaluate the 

24 safety or effectiveness of an animal drug applicaVerDate Mar 15 2010 22:04 Aug 02, 2013 Jkt 029200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6203 E:\BILLS\H1407.RH H1407

sroberts on DSK5SPTVN1PROD with BILLS
6 

•HR 1407 RH

1 tion or supplemental animal drug application in 

2 the event of their filing. 

3 ‘‘(6) The term ‘animal drug sponsor’ means ei4 ther an applicant named in an animal drug applica5 tion that has not been withdrawn by the applicant 

6 and for which approval has not been withdrawn by 

7 the Secretary, or a person who has submitted an in8 vestigational animal drug submission that has not 

9 been terminated or otherwise rendered inactive by the 

10 Secretary. 

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

12 respect to an animal drug product, a finished dosage 

13 form which is approved for administration to an ani14 mal without substantial further manufacturing. Such 

15 term includes animal drug products intended for mix16 ing in animal feeds. 

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

18 drug applications’ means the following activities of 

19 the Secretary with respect to the review of animal 

20 drug applications, supplemental animal drug appli21 cations, and investigational animal drug submissions: 

22 ‘‘(A) The activities necessary for the review 

23 of animal drug applications, supplemental ani24 mal drug applications, and investigational ani25 mal drug submissions. 


sroberts on DSK5SPTVN1PROD with BILLS
7 

•HR 1407 RH

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

2 approve animal drug applications or supple3 mental animal drug applications or which set 

4 forth in detail the specific deficiencies in animal 

5 drug applications, supplemental animal drug 

6 applications, or investigational animal drug 

7 submissions and, where appropriate, the actions 

8 necessary to place such applications, supple9 ments, or submissions in condition for approval. 

10 ‘‘(C) The inspection of animal drug estab11 lishments and other facilities undertaken as part 

12 of the Secretary’s review of pending animal drug 

13 applications, supplemental animal drug applica14 tions, and investigational animal drug submis15 sions. 

16 ‘‘(D) Monitoring of research conducted in 

17 connection with the review of animal drug appli18 cations, supplemental animal drug applications, 

19 and investigational animal drug submissions. 

20 ‘‘(E) The development of regulations and 

21 policy related to the review of animal drug ap22 plications, supplemental animal drug applica23 tions, and investigational animal drug submis24 sions. 


sroberts on DSK5SPTVN1PROD with BILLS
8 

•HR 1407 RH

1 ‘‘(F) Development of standards for products 

2 subject to review. 

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

4 animal drug sponsor. 

5 ‘‘(H) Review of advertising and labeling 

6 prior to approval of an animal drug application 

7 or supplemental animal drug application, but 

8 not after such application has been approved. 

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

10 process for the review of animal drug applications’ 

11 means the expenses in connection with the process for 

12 the review of animal drug applications for— 

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

14 Drug Administration, contractors of the Food 

15 and Drug Administration, advisory committees 

16 consulted with respect to the review of specific 

17 animal drug applications, supplemental animal 

18 drug applications, or investigational animal 

19 drug submissions, and costs related to such offi20 cers, employees, committees, and contractors, in21 cluding costs for travel, education, and recruit22 ment and other personnel activities; 

23 ‘‘(B) management of information and the 

24 acquisition, maintenance, and repair of com25 puter resources; 


sroberts on DSK5SPTVN1PROD with BILLS
9 

•HR 1407 RH

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

2 repair of facilities and acquisition, maintenance, 

3 and repair of fixtures, furniture, scientific equip4 ment, and other necessary materials and sup5 plies; and 

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

7 accounting for resources allocated for the review 

8 of animal drug applications, supplemental ani9 mal drug applications, and investigational ani10 mal drug submissions. 

11 ‘‘(10) The term ‘adjustment factor’ applicable to 

12 a fiscal year refers to the formula set forth in section 

13 735(8) with the base or comparator month being Oc14 tober 2002. 

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

16 thereof. 

17 ‘‘(12) The term ‘affiliate’ refers to the definition 

18 set forth in section 735(11).’’. 

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

20 FEES. 

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

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


sroberts on DSK5SPTVN1PROD with BILLS
10 

•HR 1407 RH

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

2 FEES. 

3 ‘‘(a) TYPES OF FEES.—Beginning in fiscal year 2004, 

4 the Secretary shall assess and collect fees in accordance with 

5 this section as follows: 

6 ‘‘(1) ANIMAL DRUG APPLICATION AND SUPPLE7 MENT FEE.— 

8 ‘‘(A) IN GENERAL.—Each person that sub9 mits, on or after September 1, 2003, an animal 

10 drug application or a supplemental animal drug 

11 application shall be subject to a fee as follows: 

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

13 for an animal drug application, except an 

14 animal drug application described in sec15 tion 512(d)(4). 

16 ‘‘(ii) A fee established in subsection (c), 

17 in an amount that is equal to 50 percent of 

18 the amount of the fee under clause (i), for— 

19 ‘‘(I) a supplemental animal drug 

20 application for which safety or effec21 tiveness data are required; and 

22 ‘‘(II) an animal drug application 

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

24 ‘‘(B) PAYMENT.—The fee required by sub25 paragraph (A) shall be due upon submission of 


sroberts on DSK5SPTVN1PROD with BILLS
11 

•HR 1407 RH

1 the animal drug application or supplemental 

2 animal drug application. 

3 ‘‘(C) EXCEPTION FOR PREVIOUSLY FILED

4 APPLICATION OR SUPPLEMENT.—If an animal 

5 drug application or a supplemental animal drug 

6 application was submitted by a person that paid 

7 the fee for such application or supplement, was 

8 accepted for filing, and was not approved or was 

9 withdrawn (without a waiver or refund), the 

10 submission of an animal drug application or a 

11 supplemental animal drug application for the 

12 same product by the same person (or the person’s 

13 licensee, assignee, or successor) shall not be sub14 ject to a fee under subparagraph (A). 

15 ‘‘(D) REFUND OF FEE IF APPLICATION RE16 FUSED FOR FILING.—The Secretary shall refund 

17 75 percent of the fee paid under subparagraph 

18 (B) for any animal drug application or supple19 mental animal drug application which is refused 

20 for filing. 

21 ‘‘(E) REFUND OF FEE IF APPLICATION

22 WITHDRAWN.—If an animal drug application or 

23 a supplemental animal drug application is with24 drawn after the application or supplement was 

25 filed, the Secretary may refund the fee or portion 


sroberts on DSK5SPTVN1PROD with BILLS
12 

•HR 1407 RH

1 of the fee paid under subparagraph (B) if no 

2 substantial work was performed on the applica3 tion or supplement after the application or sup4 plement was filed. The Secretary shall have the 

5 sole discretion to refund the fee under this para6 graph. A determination by the Secretary con7 cerning a refund under this paragraph shall not 

8 be reviewable. 

9 ‘‘(2) ANIMAL DRUG PRODUCT FEE.— 

10 ‘‘(A) IN GENERAL.—Each person— 

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

12 an animal drug application or supple13 mental animal drug application for an ani14 mal drug product which has been submitted 

15 for listing under section 510; and 

16 ‘‘(ii) who, after September 1, 2003, had 

17 pending before the Secretary an animal 

18 drug application or supplemental animal 

19 drug application, 

20 shall pay for each such animal drug product the 

21 annual fee established in subsection (c). 

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

23 shall be payable for the fiscal year in which the 

24 animal drug product is first submitted for list25 ing under section 510, or is submitted for reVerDate Mar 15 2010 22:04 Aug 02, 2013 Jkt 029200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6203 E:\BILLS\H1407.RH H1407

sroberts on DSK5SPTVN1PROD with BILLS
13 

•HR 1407 RH

1 listing under section 510 if the animal drug 

2 product has been withdrawn from listing and re3 listed. After such fee is paid for that fiscal year, 

4 such fee shall be due each subsequent fiscal year 

5 that the product remains listed, upon the later 

6 of— 

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

8 date of enactment of an appropriations Act 

9 providing for the collection and obligation 

10 of fees for such fiscal year under this sec11 tion; or 

12 ‘‘(ii) January 31 of each year. 

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

14 only once for each animal drug product for a fis15 cal year in which the fee is payable. 

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

17 ‘‘(A) IN GENERAL.—Each person— 

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

19 through an affiliate, an animal drug estab20 lishment; 

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

22 an animal drug application or supple23 mental animal drug application for an ani24 mal drug product which has been submitted 

25 for listing under section 510; and 


sroberts on DSK5SPTVN1PROD with BILLS
14 

•HR 1407 RH

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

2 had pending before the Secretary an animal 

3 drug application or supplemental animal 

4 drug application, 

5 shall be assessed an annual establishment fee as 

6 established in subsection (c) for each animal 

7 drug establishment listed in its approved animal 

8 drug application as an establishment that manu9 factures the animal drug product named in the 

10 application. 

11 ‘‘(B) PAYMENT; FEE DUE DATE.—The an12 nual establishment fee shall be assessed in each 

13 fiscal year in which the animal drug product 

14 named in the application is assessed a fee under 

15 paragraph (2) unless the animal drug establish16 ment listed in the application does not engage in 

17 the manufacture of the animal drug product dur18 ing the fiscal year. The fee under this paragraph 

19 for a fiscal year shall be due upon the later of— 

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

21 date of enactment of an appropriations Act 

22 providing for the collection and obligation 

23 of fees for such fiscal year under this sec24 tion; or 

25 ‘‘(ii) January 31 of each year. 


sroberts on DSK5SPTVN1PROD with BILLS
15 

•HR 1407 RH

1 ‘‘(C) LIMITATION.— 

2 ‘‘(i) IN GENERAL.—An establishment 

3 shall be assessed only one fee per fiscal year 

4 under this section, subject to clause (ii). 

5 ‘‘(ii) CERTAIN MANUFACTURERS.—If a 

6 single establishment manufactures both ani7 mal drug products and prescription drug 

8 products, as defined in section 735(3), such 

9 establishment shall be assessed both the ani10 mal drug establishment fee and the pre11 scription drug establishment fee, as set forth 

12 in section 736(a)(2), within a single fiscal 

13 year. 

14 ‘‘(4) ANIMAL DRUG SPONSOR FEE.— 

15 ‘‘(A) IN GENERAL.—Each person— 

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

17 animal drug sponsor within a fiscal year; 

18 and 

19 ‘‘(ii) who, after September 1, 2003, had 

20 pending before the Secretary an animal 

21 drug application, a supplemental animal 

22 drug application, or an investigational ani23 mal drug submission, 

24 shall be assessed an annual sponsor fee as estab25 lished under subsection (c). 


sroberts on DSK5SPTVN1PROD with BILLS
16 

•HR 1407 RH

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

2 under this paragraph for a fiscal year shall be 

3 due upon the later of— 

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

5 date of enactment of an appropriations Act 

6 providing for the collection and obligation 

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

9 ‘‘(ii) January 31 of each year. 

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

11 sponsor shall pay only one such fee each fiscal 

12 year. 

13 ‘‘(b) FEE REVENUE AMOUNTS.— 

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

15 (d), (f), and (g)— 

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

17 under subsection (a) shall be established to gen18 erate a total revenue amount of $23,600,000; and 

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

20 2018, the fees required under subsection (a) shall 

21 be established to generate a total revenue amount 

22 of $21,600,000. 

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

24 amount determined for a fiscal year under paragraph 

25 (1)— 


sroberts on DSK5SPTVN1PROD with BILLS
17 

•HR 1407 RH

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

2 under subsection (a)(1) (relating to animal drug 

3 applications and supplements); 

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

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

6 products); 

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

8 under subsection (a)(3) (relating to animal drug 

9 establishments); and 

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

11 under subsection (a)(4) (relating to animal drug 

12 sponsors). 

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

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

15 establish, 60 days before the start of each fiscal year 

16 beginning after September 30, 2003, for that fiscal 

17 year, animal drug application fees, supplemental ani18 mal drug application fees, animal drug sponsor fees, 

19 animal drug establishment fees, and animal drug 

20 product fees based on the revenue amounts established 

21 under subsection (b) and the adjustments provided 

22 under this subsection. 

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

24 2015 and subsequent fiscal years, the revenue 

25 amounts established in subsection (b) shall be adjusted 


sroberts on DSK5SPTVN1PROD with BILLS
18 

•HR 1407 RH

1 by the Secretary by notice, published in the Federal 

2 Register, for a fiscal year, by an amount equal to the 

3 sum of— 

4 ‘‘(A) one; 

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

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

7 Food and Drug Administration, of all personnel 

8 compensation and benefits paid with respect to 

9 such positions for the first 3 of the preceding 4 

10 fiscal years for which data are available, multi11 plied by the average proportion of personnel 

12 compensation and benefits costs to total Food 

13 and Drug Administration costs for the first 3 

14 years of the preceding 4 fiscal years for which 

15 data are available; and 

16 ‘‘(C) the average annual percent change 

17 that occurred in the Consumer Price Index for 

18 urban consumers (Washington-Baltimore, DC19 MD-VA-WV; not seasonally adjusted; all items 

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

21 3 years of the preceding 4 years for which data 

22 are available multiplied by the average propor23 tion of all costs other than personnel compensa24 tion and benefits costs to total Food and Drug 

25 Administration costs for the first 3 years of the 


sroberts on DSK5SPTVN1PROD with BILLS
19 

•HR 1407 RH

1 preceding 4 fiscal years for which data are avail2 able. 

3 The adjustment made each fiscal year under this 

4 paragraph shall be added on a compounded basis to 

5 the sum of all adjustments made each fiscal year after 

6 fiscal year 2014 under this paragraph. 

7 ‘‘(3) WORKLOAD ADJUSTMENT.—For fiscal year 

8 2015 and subsequent fiscal years, after the revenue 

9 amounts established in subsection (b) are adjusted for 

10 inflation in accordance with paragraph (2), the rev11 enue amounts shall be further adjusted for such fiscal 

12 year to reflect changes in the workload of the Sec13 retary for the process for the review of animal drug 

14 applications. With respect to such adjustment— 

15 ‘‘(A) such adjustment shall be determined 

16 by the Secretary based on a weighted average of 

17 the change in the total number of animal drug 

18 applications, supplemental animal drug applica19 tions for which data with respect to safety or ef20 fectiveness are required, manufacturing supple21 mental animal drug applications, investiga22 tional animal drug study submissions, and in23 vestigational animal drug protocol submissions 

24 submitted to the Secretary; 


sroberts on DSK5SPTVN1PROD with BILLS
20 

•HR 1407 RH

1 ‘‘(B) the Secretary shall publish in the Fed2 eral Register the fees resulting from such adjust3 ment and the supporting methodologies; and 

4 ‘‘(C) under no circumstances shall such ad5 justment result in fee revenues for a fiscal year 

6 that are less than the fee revenues for that fiscal 

7 year established in subsection (b), as adjusted for 

8 inflation under paragraph (2). 

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

10 2018, the Secretary may, in addition to other adjust11 ments under this subsection, further increase the fees 

12 under this section, if such an adjustment is necessary 

13 to provide for up to 3 months of operating reserves of 

14 carryover user fees for the process for the review of 

15 animal drug applications for the first 3 months of fis16 cal year 2019. If the Food and Drug Administration 

17 has carryover balances for the process for the review 

18 of animal drug applications in excess of 3 months of 

19 such operating reserves, then this adjustment will not 

20 be made. If this adjustment is necessary, then the ra21 tionale for the amount of the increase shall be con22 tained in the annual notice setting fees for fiscal year 

23 2018. 

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

25 as adjusted under this subsection, for a fiscal year 


sroberts on DSK5SPTVN1PROD with BILLS
21 

•HR 1407 RH

1 may not exceed the total costs for such fiscal year for 

2 the resources allocated for the process for the review 

3 of animal drug applications. 

4 ‘‘(d) FEE WAIVER OR REDUCTION.— 

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

6 waiver from or a reduction of one or more fees as7 sessed under subsection (a) where the Secretary finds 

8 that— 

9 ‘‘(A) the assessment of the fee would present 

10 a significant barrier to innovation because of 

11 limited resources available to such person or 

12 other circumstances; 

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

14 exceed the anticipated present and future costs 

15 incurred by the Secretary in conducting the 

16 process for the review of animal drug applica17 tions for such person; 

18 ‘‘(C) the animal drug application or supple19 mental animal drug application is intended sole20 ly to provide for use of the animal drug in— 

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

23 of Federal Regulations (or any successor 

24 regulation)) intended for use in the manuVerDate Mar 15 2010 22:04 Aug 02, 2013 Jkt 029200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6203 E:\BILLS\H1407.RH H1407

sroberts on DSK5SPTVN1PROD with BILLS
22 

•HR 1407 RH

1 facture of Type C free-choice medicated 

2 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 application 

13 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 employ21 ees 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 


sroberts on DSK5SPTVN1PROD with BILLS
23 

•HR 1407 RH

1 submits to the Secretary for review. After a small 

2 business or its affiliate is granted such a waiver, 

3 the small business or its affiliate shall pay ap4 plication fees for all subsequent animal drug ap5 plications and supplemental animal drug appli6 cations for which safety or effectiveness data are 

7 required in the same manner as an entity that 

8 does not qualify as a small business. 

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

10 require any person who applies for a waiver 

11 under paragraph (1)(E) to certify their quali12 fication for the waiver. The Secretary shall peri13 odically publish in the Federal Register a list of 

14 persons making such certifications. 

15 ‘‘(e) EFFECT OF FAILURE TO PAY FEES.—An animal 

16 drug application or supplemental animal drug application 

17 submitted by a person subject to fees under subsection (a) 

18 shall be considered incomplete and shall not be accepted for 

19 filing by the Secretary until all fees owed by such person 

20 have been paid. An investigational animal drug submission 

21 under section 739(5)(B) that is submitted by a person sub22 ject to fees under subsection (a) shall be considered incom23 plete and shall not be accepted for review by the Secretary 

24 until all fees owed by such person have been paid. The Sec25 retary may discontinue review of any animal drug applicaVerDate Mar 15 2010 22:04 Aug 02, 2013 Jkt 029200 PO 00000 Frm 00023 Fmt 6652 Sfmt 6203 E:\BILLS\H1407.RH H1407

sroberts on DSK5SPTVN1PROD with BILLS
24 

•HR 1407 RH

1 tion, supplemental animal drug application, or investiga2 tional animal drug submission from a person if such person 

3 has not submitted for payment all fees owed under this sec4 tion by 30 days after the date upon which they are due. 

5 ‘‘(f) ASSESSMENT OF FEES.— 

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

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

8 fiscal year 2003 unless appropriations for salaries 

9 and expenses of the Food and Drug Administration 

10 for such fiscal year (excluding the amount of fees ap11 propriated for such fiscal year) are equal to or greater 

12 than the amount of appropriations for the salaries 

13 and expenses of the Food and Drug Administration 

14 for the fiscal year 2003 (excluding the amount of fees 

15 appropriated for such fiscal year) multiplied by the 

16 adjustment factor applicable to the fiscal year in17 volved. 

18 ‘‘(2) AUTHORITY.—If the Secretary does not as19 sess fees under subsection (a) during any portion of 

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

21 later date in such fiscal year the Secretary may assess 

22 such fees, the Secretary may assess and collect such 

23 fees, without any modification in the rate, for animal 

24 drug applications, supplemental animal drug appli25 cations, investigational animal drug submissions, 


sroberts on DSK5SPTVN1PROD with BILLS
25 

•HR 1407 RH

1 animal drug sponsors, animal drug establishments, 

2 and animal drug products at any time in such fiscal 

3 year notwithstanding the provisions of subsection (a) 

4 relating to the date fees are to be paid. 

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

6 ‘‘(1) IN GENERAL.—Subject to paragraph (2)(C), 

7 fees authorized under subsection (a) shall be collected 

8 and available for obligation only to the extent and in 

9 the amount provided in advance in appropriations 

10 Acts. Such fees are authorized to be appropriated to 

11 remain available until expended. Such sums as may 

12 be necessary may be transferred from the Food and 

13 Drug Administration salaries and expenses appro14 priation account without fiscal year limitation to 

15 such appropriation account for salary and expenses 

16 with such fiscal year limitation. The sums transferred 

17 shall be available solely for the process for the review 

18 of animal drug applications. 

19 ‘‘(2) COLLECTIONS AND APPROPRIATION ACTS.— 

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

21 this section— 

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

23 be collected and available in each fiscal year 

24 in an amount not to exceed the amount 

25 specified in appropriation Acts, or otherVerDate Mar 15 2010 22:04 Aug 02, 2013 Jkt 029200 PO 00000 Frm 00025 Fmt 6652 Sfmt 6203 E:\BILLS\H1407.RH H1407

sroberts on DSK5SPTVN1PROD with BILLS
26 

•HR 1407 RH

1 wise made available for obligation for such 

2 fiscal year; and 

3 ‘‘(ii) shall be available to defray in4 creases in the costs of the resources allocated 

5 for the process for the review of animal drug 

6 applications (including increases in such 

7 costs for an additional number of full-time 

8 equivalent positions in the Department of 

9 Health and Human Services to be engaged 

10 in such process) over such costs, excluding 

11 costs paid from fees collected under this sec12 tion, for fiscal year 2003 multiplied by the 

13 adjustment factor. 

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

15 considered to have met the requirements of sub16 paragraph (A)(ii) in any fiscal year if the costs 

17 funded by appropriations and allocated for the 

18 process for the review of animal drug applica19 tions— 

20 ‘‘(i) are not more than 3 percent below 

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

22 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 22:04 Aug 02, 2013 Jkt 029200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6203 E:\BILLS\H1407.RH H1407

sroberts on DSK5SPTVN1PROD with BILLS
27 

•HR 1407 RH

1 lowing the subsequent fiscal year are de2 creased by the amount in excess of 3 percent 

3 by which such costs fell below the level speci4 fied in subparagraph (A)(ii); and 

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

6 percent below the level specified in subpara7 graph (A)(ii). 

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

9 Payment of fees authorized under this section for 

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

11 may be accepted by the Secretary in accordance 

12 with authority provided in advance in a prior 

13 year appropriations Act. 

14 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For 

15 each of the fiscal years 2014 through 2018, there is 

16 authorized to be appropriated for fees under this sec17 tion an amount equal to the total revenue amount de18 termined under subsection (b) for the fiscal year, as 

19 adjusted or otherwise affected under subsection (c) 

20 and paragraph (4). 

21 ‘‘(4) OFFSET OF OVERCOLLECTIONS; RECOVERY

22 OF COLLECTION SHORTFALLS.— 

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

24 sum of the cumulative amount of fees collected 

25 under this section for fiscal years 2014 through 


sroberts on DSK5SPTVN1PROD with BILLS
28 

•HR 1407 RH

1 2016 and the amount of fees estimated to be col2 lected under this section for fiscal year 2017 (in3 cluding any increased fee collections attributable 

4 to subparagraph (B)), exceeds the cumulative 

5 amount appropriated pursuant to paragraph (3) 

6 for the fiscal years 2014 through 2017, the excess 

7 amount shall be credited to the appropriation 

8 account of the Food and Drug Administration as 

9 provided in paragraph (1), and shall be sub10 tracted from the amount of fees that would other11 wise be authorized to be collected under this sec12 tion pursuant to appropriation Acts for fiscal 

13 year 2018. 

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

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

17 year 2016, the amount of fees otherwise au18 thorized to be collected under this section 

19 shall be increased by the amount, if any, by 

20 which the amount collected under this sec21 tion and appropriated for fiscal year 2014 

22 falls below the amount of fees authorized for 

23 fiscal year 2014 under paragraph (3). 

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

25 year 2017, the amount of fees otherwise auVerDate Mar 15 2010 22:04 Aug 02, 2013 Jkt 029200 PO 00000 Frm 00028 Fmt 6652 Sfmt 6203 E:\BILLS\H1407.RH H1407

sroberts on DSK5SPTVN1PROD with BILLS
29 

•HR 1407 RH

1 thorized to be collected under this section 

2 shall be increased by the amount, if any, by 

3 which the amount collected under this sec4 tion and appropriated for fiscal year 2015 

5 falls below the amount of fees authorized for 

6 fiscal year 2015 under paragraph (3). 

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

8 year 2018, the amount of fees otherwise au9 thorized to be collected under this section 

10 (including any reduction in the authorized 

11 amount under subparagraph (A)), shall be 

12 increased by the cumulative amount, if any, 

13 by which the amount collected under this 

14 section and appropriated for fiscal years 

15 2016 and 2017 (including estimated collec16 tions for fiscal year 2017) falls below the 

17 cumulative amount of fees authorized under 

18 paragraph (3) for fiscal years 2016 and 

19 2017. 

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

21 where the Secretary does not receive payment of a fee as22 sessed under subsection (a) within 30 days after it is due, 

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

24 Government subject to subchapter II of chapter 37 of title 

25 31, United States Code. 


sroberts on DSK5SPTVN1PROD with BILLS
30 

•HR 1407 RH

1 ‘‘(i) WRITTEN REQUESTS FOR WAIVERS, REDUCTIONS, 

2 AND REFUNDS.—To qualify for consideration for a waiver 

3 or reduction under subsection (d), or for a refund of any 

4 fee collected in accordance with subsection (a), a person 

5 shall submit to the Secretary a written request for such 

6 waiver, reduction, or refund not later than 180 days after 

7 such fee is due. 

8 ‘‘(j) CONSTRUCTION.—This section may not be con9 strued to require that the number of full-time equivalent 

10 positions in the Department of Health and Human Serv11 ices, for officers, employees, and advisory committees not 

12 engaged in the process of the review of animal drug applica13 tions, be reduced to offset the number of officers, employees, 

14 and advisory committees so engaged. 

15 ‘‘(k) ABBREVIATED NEW ANIMAL DRUG APPLICA16 TIONS.—The Secretary shall— 

17 ‘‘(1) to the extent practicable, segregate the re18 view of abbreviated new animal drug applications 

19 from the process for the review of animal drug appli20 cations; and 

21 ‘‘(2) adopt other administrative procedures to 

22 ensure that review times of abbreviated new animal 

23 drug applications do not increase from their current 

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


sroberts on DSK5SPTVN1PROD with BILLS
31 

•HR 1407 RH

1 SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 

2 Section 740A of the Federal Food, Drug, and Cosmetic 

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

4 ‘‘SEC. 740A. REAUTHORIZATION; REPORTING REQUIRE5 MENTS. 

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

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

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

9 the Secretary shall prepare and submit to the Committee 

10 on Energy and Commerce of the House of Representatives 

11 and the Committee on Health, Education, Labor, and Pen12 sions of the Senate a report concerning the progress of the 

13 Food and Drug Administration in achieving the goals iden14 tified in the letters described in section 101(b) of the Animal 

15 Drug User Fee Amendments of 2013 toward expediting the 

16 animal drug development process and the review of the new 

17 and supplemental animal drug applications and investiga18 tional animal drug submissions during such fiscal year, the 

19 future plans of the Food and Drug Administration for meet20 ing the goals, the review times for abbreviated new animal 

21 drug applications, and the administrative procedures 

22 adopted by the Food and Drug Administration to ensure 

23 that review times for abbreviated new animal drug applica24 tions are not increased from their current level due to ac25 tivities under the user fee program. 


sroberts on DSK5SPTVN1PROD with BILLS
32 

•HR 1407 RH

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

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

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

4 Secretary shall prepare and submit to the Committee on 

5 Energy and Commerce of the House of Representatives and 

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

7 of the Senate a report on the implementation of the author8 ity for such fees during such fiscal year and the use, by 

9 the Food and Drug Administration, of the fees collected dur10 ing such fiscal year for which the report is made. 

11 ‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall make 

12 the reports required under subsections (a) and (b) available 

13 to the public on the Internet Web site of the Food and Drug 

14 Administration. 

15 ‘‘(d) REAUTHORIZATION.— 

16 ‘‘(1) CONSULTATION.—In developing rec17 ommendations to present to the Congress with respect 

18 to the goals, and plans for meeting the goals, for the 

19 process for the review of animal drug applications for 

20 the first 5 fiscal years after fiscal year 2018, and for 

21 the reauthorization of this part for such fiscal years, 

22 the Secretary shall consult with— 

23 ‘‘(A) the Committee on Energy and Com24 merce of the House of Representatives; 


sroberts on DSK5SPTVN1PROD with BILLS
33 

•HR 1407 RH

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

2 Labor, and Pensions of the Senate; 

3 ‘‘(C) scientific and academic experts; 

4 ‘‘(D) veterinary professionals; 

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

7 ‘‘(F) the regulated industry. 

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

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

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

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

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

17 the goals referred to in subsection (a); 

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

19 public meeting to obtain written comments from 

20 the public suggesting changes to this part; and 

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

22 Drug Administration’s Internet Web site. 

23 ‘‘(3) PERIODIC CONSULTATION.—Not less fre24 quently than once every 4 months during negotiations 

25 with the regulated industry, the Secretary shall hold 


sroberts on DSK5SPTVN1PROD with BILLS
34 

•HR 1407 RH

1 discussions with representatives of veterinary, patient, 

2 and consumer advocacy groups to continue discus3 sions of their views on the reauthorization and their 

4 suggestions for changes to this part as expressed 

5 under paragraph (2). 

6 ‘‘(4) PUBLIC REVIEW OF RECOMMENDATIONS.— 

7 After negotiations with the regulated industry, the 

8 Secretary shall— 

9 ‘‘(A) present the recommendations developed 

10 under paragraph (1) to the congressional com11 mittees specified in such paragraph; 

12 ‘‘(B) publish such recommendations in the 

13 Federal Register; 

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

15 public to provide written comments on such rec16 ommendations; 

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

18 may present its views on such recommendations; 

19 and 

20 ‘‘(E) after consideration of such public 

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

23 ‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.—Not 

24 later than January 15, 2018, the Secretary shall 

25 transmit to Congress the revised recommendations 


sroberts on DSK5SPTVN1PROD with BILLS
35 

•HR 1407 RH

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

2 comments received under such paragraph, and any 

3 changes made to the recommendations in response to 

4 such views and comments. 

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

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

8 paragraphs (1) through (5) to Congress, the Sec9 retary shall make publicly available, on the 

10 Internet Web site of the Food and Drug Admin11 istration, minutes ofPublic Law 110-316 (122 

12 Stat. 3509)’’ all negotiation meetings conducted 

13 under this subsection between the Food and Drug 

14 Administration and the regulated industry. 

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

16 under subparagraph (A) shall summarize any 

17 substantive proposal made by any party to the 

18 negotiations as well as significant controversies 

19 or differences of opinion during the negotiations 

20 and their resolution.’’. 

21 SEC. 105. SAVINGS CLAUSE. 

22 Notwithstanding the amendments made by this title, 

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

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

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


sroberts on DSK5SPTVN1PROD with BILLS
36 

•HR 1407 RH

1 title, shall continue to be in effect with respect to animal 

2 drug applications and supplemental animal drug applica3 tions (as defined in such part as of such day) that on or 

4 after October 1, 2008, but before October 1, 2013, were ac5 cepted by the Food and Drug Administration for filing with 

6 respect to assessing and collecting any fee required by such 

7 part for a fiscal year prior to fiscal year 2014. 

8 SEC. 106. EFFECTIVE DATE. 

9 The amendments made by this title shall take effect 

10 on October 1, 2013, or the date of enactment of this title, 

11 whichever is later, except that fees under part 4 of sub12 chapter C of chapter VII of the Federal Food, Drug, and 

13 Cosmetic Act, as amended by this title, shall be assessed for 

14 all animal drug applications and supplemental animal 

15 drug applications received on or after October 1, 2013, re16 gardless of the date of the enactment of this title. 

17 SEC. 107. SUNSET DATES. 

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

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

20 cease to be effective October 1, 2018. 

21 (b) REPORTING REQUIREMENTS.—Section 740A of the 

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

23 13) shall cease to be effective January 31, 2019. 

24 (c) PREVIOUS SUNSET PROVISION.— 


sroberts on DSK5SPTVN1PROD with BILLS
37 

•HR 1407 RH

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

2 Drug User Fee Amendments of 2008 (Public Law 

3 110–316) is repealed. 

4 (2) CONFORMING AMENDMENT.—Public Law 

5 110–316 (122 Stat. 3509) is amended in the table of 

6 contents in section 1, by striking the item relating to 

7 section 108. 

8 (d) TECHNICAL CLARIFICATION.—Effective November 

9 18, 2003, section 5 of the Animal Drug User Fee Act of 

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

11 TITLE II—ANIMAL GENERIC 

12 DRUG USER FEE AMENDMENTS 

13 SECTION 201. SHORT TITLE; FINDING. 

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

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

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

17 dedicated toward expediting the generic new animal drug 

18 development process and the review of abbreviated applica19 tions for generic new animal drugs, supplemental abbre20 viated applications for generic new animal drugs, and in21 vestigational submissions for generic new animal drugs as 

22 set forth in the goals identified in the letters from the Sec23 retary of Health and Human Services to the Chairman of 

24 the Committee on Energy and Commerce of the House of 

25 Representatives and the Chairman of the Committee on 


sroberts on DSK5SPTVN1PROD with BILLS
38 

•HR 1407 RH

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

2 set forth in the Congressional Record. 

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

4 ANIMAL DRUG FEES. 

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

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

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

8 ANIMAL DRUG FEES. 

9 ‘‘(a) TYPES OF FEES.—Beginning with respect to fis10 cal year 2009, the Secretary shall assess and collect fees in 

11 accordance with this section as follows: 

12 ‘‘(1) ABBREVIATED APPLICATION FEE.— 

13 ‘‘(A) IN GENERAL.—Each person that sub14 mits, on or after July 1, 2008, an abbreviated 

15 application for a generic new animal drug shall 

16 be subject to a fee as established in subsection (c) 

17 for such an application. 

18 ‘‘(B) PAYMENT.—The fee required by sub19 paragraph (A) shall be due upon submission of 

20 the abbreviated application. 

21 ‘‘(C) EXCEPTIONS.— 

22 ‘‘(i) PREVIOUSLY FILED APPLICA23 TION.—If an abbreviated application was 

24 submitted by a person that paid the fee for 

25 such application, was accepted for filing, 


sroberts on DSK5SPTVN1PROD with BILLS
39 

•HR 1407 RH

1 and was not approved or was withdrawn 

2 (without a waiver or refund), the submis3 sion of an abbreviated application for the 

4 same product by the same person (or the 

5 person’s licensee, assignee, or successor) 

6 shall not be subject to a fee under subpara7 graph (A). 

8 ‘‘(ii) CERTAIN ABBREVIATED APPLICA9 TIONS INVOLVING COMBINATION ANIMAL

10 DRUGS.—An abbreviated application for an 

11 animal drug described in section 512(d)(4) 

12 and submitted on or after October 1, 2013, 

13 shall be subject to a fee equal to 50 percent 

14 of the amount of the abbreviated application 

15 fee established in subsection (c). 

16 ‘‘(D) REFUND OF FEE IF APPLICATION RE17 FUSED FOR FILING.—The Secretary shall refund 

18 75 percent of the fee paid under subparagraph 

19 (B) for any abbreviated application which is re20 fused for filing. 

21 ‘‘(E) REFUND OF FEE IF APPLICATION

22 WITHDRAWN.—If an abbreviated application is 

23 withdrawn after the application was filed, the 

24 Secretary may refund the fee or portion of the fee 

25 paid under subparagraph (B) if no substantial 


sroberts on DSK5SPTVN1PROD with BILLS
40 

•HR 1407 RH

1 work was performed on the application after the 

2 application was filed. The Secretary shall have 

3 the sole discretion to refund the fee under this 

4 subparagraph. A determination by the Secretary 

5 concerning a refund under this subparagraph 

6 shall not be reviewable. 

7 ‘‘(2) GENERIC NEW ANIMAL DRUG PRODUCT

8 FEE.— 

9 ‘‘(A) IN GENERAL.—Each person— 

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

11 an abbreviated application or supplemental 

12 abbreviated application for a generic new 

13 animal drug product which has been sub14 mitted for listing under section 510; and 

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

16 pending before the Secretary an abbreviated 

17 application or supplemental abbreviated ap18 plication, 

19 shall pay for each such generic new animal drug 

20 product the annual fee established in subsection 

21 (c). 

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

23 shall be payable for the fiscal year in which the 

24 generic new animal drug product is first sub25 mitted for listing under section 510, or is subVerDate Mar 15 2010 22:04 Aug 02, 2013 Jkt 029200 PO 00000 Frm 00040 Fmt 6652 Sfmt 6203 E:\BILLS\H1407.RH H1407

sroberts on DSK5SPTVN1PROD with BILLS
41 

•HR 1407 RH

1 mitted for relisting under section 510 if the ge2 neric new animal drug product has been with3 drawn from listing and relisted. After such fee is 

4 paid for that fiscal year, such fee shall be due 

5 each subsequent fiscal year that the product re6 mains listed, upon the later of— 

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

8 date of enactment of an appropriations Act 

9 providing for the collection and obligation 

10 of fees for such fiscal year under this sec11 tion; or 

12 ‘‘(ii) January 31 of each year. 

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

14 only once for each generic new animal drug 

15 product for a fiscal year in which the fee is pay16 able. 

17 ‘‘(3) GENERIC NEW ANIMAL DRUG SPONSOR

18 FEE.— 

19 ‘‘(A) IN GENERAL.—Each person— 

20 ‘‘(i) who meets the definition of a ge21 neric new animal drug sponsor within a 

22 fiscal year; and 

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

24 pending before the Secretary an abbreviated 


sroberts on DSK5SPTVN1PROD with BILLS
42 

•HR 1407 RH

1 application, a supplemental abbreviated ap2 plication, or an investigational submission, 

3 shall be assessed an annual generic new animal 

4 drug sponsor fee as established under subsection 

5 (c). 

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

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

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

9 date of enactment of an appropriations Act 

10 providing for the collection and obligation 

11 of fees for such fiscal year under this sec12 tion; or 

13 ‘‘(ii) January 31 of each year. 

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

15 animal drug sponsor shall pay only 1 such fee 

16 each fiscal year, as follows: 

17 ‘‘(i) 100 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 6 ap21 proved abbreviated applications. 

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

23 generic new animal drug sponsor fee pub24 lished for that fiscal year under subsection 

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


sroberts on DSK5SPTVN1PROD with BILLS
43 

•HR 1407 RH

1 fewer than 7 approved abbreviated applica2 tions. 

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

4 generic new animal drug sponsor fee pub5 lished for that fiscal year under subsection 

6 (c) for an applicant with 1 or fewer ap7 proved abbreviated applications. 

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

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

10 established to generate fee revenue amounts as follows: 

11 ‘‘(1) TOTAL FEE REVENUES FOR APPLICATION

12 FEES.—The total fee revenues to be collected in abbre13 viated application fees under subsection (a)(1) shall 

14 be $1,832,000 for fiscal year 2014, $1,736,000 for fis15 cal year 2015, $1,857,000 for fiscal year 2016, 

16 $1,984,000 for fiscal year 2017, and $2,117,000 for 

17 fiscal year 2018. 

18 ‘‘(2) TOTAL FEE REVENUES FOR PRODUCT

19 FEES.—The total fee revenues to be collected in ge20 neric new animal drug product fees under subsection 

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

22 $2,604,000 for fiscal year 2015, $2,786,000 for fiscal 

23 year 2016, $2,976,000 for fiscal year 2017, and 

24 $3,175,000 for fiscal year 2018. 


sroberts on DSK5SPTVN1PROD with BILLS
44 

•HR 1407 RH

1 ‘‘(3) TOTAL FEE REVENUES FOR SPONSOR

2 FEES.—The total fee revenues to be collected in ge3 neric new animal drug sponsor fees under subsection 

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

5 $2,604,000 for fiscal year 2015, $2,786,000 for fiscal 

6 year 2016, $2,976,000 for fiscal year 2017, and 

7 $3,175,000 for fiscal year 2018. 

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

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

10 establish, 60 days before the start of each fiscal year 

11 beginning after September 30, 2008, for that fiscal 

12 year, abbreviated application fees, generic new ani13 mal drug sponsor fees, and generic new animal drug 

14 product fees, based on the revenue amounts established 

15 under subsection (b) and the adjustments provided 

16 under this subsection. 

17 ‘‘(2) WORKLOAD ADJUSTMENT.—The fee revenues 

18 shall be adjusted each fiscal year after fiscal year 

19 2014 to reflect changes in review workload. With re20 spect to such adjustment: 

21 ‘‘(A) This adjustment shall be determined 

22 by the Secretary based on a weighted average of 

23 the change in the total number of abbreviated 

24 applications for generic new animal drugs, man25 ufacturing supplemental abbreviated applicaVerDate Mar 15 2010 22:04 Aug 02, 2013 Jkt 029200 PO 00000 Frm 00044 Fmt 6652 Sfmt 6203 E:\BILLS\H1407.RH H1407

sroberts on DSK5SPTVN1PROD with BILLS
45 

•HR 1407 RH

1 tions for generic new animal drugs, investiga2 tional generic new animal drug study submis3 sions, and investigational generic new animal 

4 drug protocol submissions submitted to the Sec5 retary. The Secretary shall publish in the Fed6 eral Register the fees resulting from this adjust7 ment and the supporting methodologies. 

8 ‘‘(B) Under no circumstances shall this 

9 workload adjustment result in fee revenues for a 

10 fiscal year that are less than the fee revenues for 

11 that fiscal year established in subsection (b). 

12 ‘‘(3) FINAL YEAR ADJUSTMENT.—For fiscal year 

13 2018, the Secretary may, in addition to other adjust14 ments under this subsection, further increase the fees 

15 under this section, if such an adjustment is necessary, 

16 to provide for up to 3 months of operating reserves of 

17 carryover user fees for the process for the review of ab18 breviated applications for generic new animal drugs 

19 for the first 3 months of fiscal year 2019. If the Food 

20 and Drug Administration has carryover balances for 

21 the process for the review of abbreviated applications 

22 for generic new animal drugs in excess of 3 months 

23 of such operating reserves, then this adjustment shall 

24 not be made. If this adjustment is necessary, then the 

25 rationale for the amount of the increase shall be conVerDate Mar 15 2010 22:04 Aug 02, 2013 Jkt 029200 PO 00000 Frm 00045 Fmt 6652 Sfmt 6203 E:\BILLS\H1407.RH H1407

sroberts on DSK5SPTVN1PROD with BILLS
46 

•HR 1407 RH

1 tained in the annual notice setting fees for fiscal year 

2 2018. 

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

4 as adjusted under this subsection, for a fiscal year 

5 may not exceed the total costs for such fiscal year for 

6 the resources allocated for the process for the review 

7 of abbreviated applications for generic new animal 

8 drugs. 

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

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

11 assessed under subsection (a) where the Secretary finds that 

12 the generic new animal drug is intended solely to provide 

13 for a minor use or minor species indication. 

14 ‘‘(e) EFFECT OF FAILURE TO PAY FEES.—An abbre15 viated application for a generic new animal drug submitted 

16 by a person subject to fees under subsection (a) shall be con17 sidered incomplete and shall not be accepted for filing by 

18 the Secretary until all fees owed by such person have been 

19 paid. An investigational submission for a generic new ani20 mal drug that is submitted by a person subject to fees under 

21 subsection (a) shall be considered incomplete and shall not 

22 be accepted for review by the Secretary until all fees owed 

23 by such person have been paid. The Secretary may dis24 continue review of any abbreviated application for a ge25 neric new animal drug, supplemental abbreviated applicaVerDate Mar 15 2010 22:04 Aug 02, 2013 Jkt 029200 PO 00000 Frm 00046 Fmt 6652 Sfmt 6203 E:\BILLS\H1407.RH H1407

sroberts on DSK5SPTVN1PROD with BILLS
47 

•HR 1407 RH

1 tion for a generic new animal drug, or investigational sub2 mission for a generic new animal drug from a person if 

3 such person has not submitted for payment all fees owed 

4 under this section by 30 days after the date upon which 

5 they are due. 

6 ‘‘(f) ASSESSMENT OF FEES.— 

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

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

9 fiscal year 2008 unless appropriations for salaries 

10 and expenses of the Food and Drug Administration 

11 for such fiscal year (excluding the amount of fees ap12 propriated for such fiscal year) are equal to or greater 

13 than the amount of appropriations for the salaries 

14 and expenses of the Food and Drug Administration 

15 for the fiscal year 2003 (excluding the amount of fees 

16 appropriated for such fiscal year) multiplied by the 

17 adjustment factor applicable to the fiscal year in18 volved. 

19 ‘‘(2) AUTHORITY.—If the Secretary does not as20 sess fees under subsection (a) during any portion of 

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

22 later date in such fiscal year the Secretary may assess 

23 such fees, the Secretary may assess and collect such 

24 fees, without any modification in the rate, for abbre25 viated applications, generic new animal drug sponVerDate Mar 15 2010 22:04 Aug 02, 2013 Jkt 029200 PO 00000 Frm 00047 Fmt 6652 Sfmt 6203 E:\BILLS\H1407.RH H1407

sroberts on DSK5SPTVN1PROD with BILLS
48 

•HR 1407 RH

1 sors, and generic new animal drug products at any 

2 time in such fiscal year notwithstanding the provi3 sions of subsection (a) relating to the date fees are to 

4 be paid. 

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

6 ‘‘(1) IN GENERAL.—Subject to paragraph (2)(C), 

7 fees authorized under subsection (a) shall be collected 

8 and available for obligation only to the extent and in 

9 the amount provided in advance in appropriations 

10 Acts. Such fees are authorized to be appropriated to 

11 remain available until expended. Such sums as may 

12 be necessary may be transferred from the Food and 

13 Drug Administration salaries and expenses appro14 priation account without fiscal year limitation to 

15 such appropriation account for salary and expenses 

16 with such fiscal year limitation. The sums transferred 

17 shall be available solely for the process for the review 

18 of abbreviated applications for generic new animal 

19 drugs. 

20 ‘‘(2) COLLECTIONS AND APPROPRIATION ACTS.— 

21 ‘‘(A) IN GENERAL.—The fees authorized by 

22 this section— 

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

24 be collected and available in each fiscal year 

25 in an amount not to exceed the amount 


sroberts on DSK5SPTVN1PROD with BILLS
49 

•HR 1407 RH

1 specified in appropriation Acts, or other2 wise made available for obligation for such 

3 fiscal year; and 

4 ‘‘(ii) shall be available to defray in5 creases in the costs of the resources allocated 

6 for the process for the review of abbreviated 

7 applications for generic new animal drugs 

8 (including increases in such costs for an ad9 ditional number of full-time equivalent po10 sitions in the Department of Health and 

11 Human Services to be engaged in such proc12 ess) over such costs, excluding costs paid 

13 from fees collected under this section, for fis14 cal year 2008 multiplied by the adjustment 

15 factor. 

16 ‘‘(B) COMPLIANCE.—The Secretary shall be 

17 considered to have met the requirements of sub18 paragraph (A)(ii) in any fiscal year if the costs 

19 funded by appropriations and allocated for the 

20 process for the review of abbreviated applications 

21 for generic new animal drugs— 

22 ‘‘(i) are not more than 3 percent below 

23 the level specified in subparagraph (A)(ii); 

24 or 


sroberts on DSK5SPTVN1PROD with BILLS
50 

•HR 1407 RH

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

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

3 and fees assessed for the fiscal year fol4 lowing the subsequent fiscal year are de5 creased by the amount in excess of 3 percent 

6 by which such costs fell below the level speci7 fied in subparagraph (A)(ii); and 

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

9 percent below the level specified in subpara10 graph (A)(ii). 

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

12 Payment of fees authorized under this section for 

13 a fiscal year, prior to the due date for such fees, 

14 may be accepted by the Secretary in accordance 

15 with authority provided in advance in a prior 

16 year appropriations Act. 

17 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

18 There are authorized to be appropriated for fees under 

19 this section— 

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

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

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

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

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


sroberts on DSK5SPTVN1PROD with BILLS
51 

•HR 1407 RH

1 as adjusted to reflect adjustments in the total fee reve2 nues made under this section and changes in the total 

3 amounts collected by abbreviated application fees, ge4 neric new animal drug sponsor fees, and generic new 

5 animal drug product fees. 

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

7 amount of fees collected under this section for the fis8 cal years 2014 through 2016 and the amount of fees 

9 estimated to be collected under this section for fiscal 

10 year 2017 exceeds the cumulative amount appro11 priated under paragraph (3) for the fiscal years 2014 

12 through 2017, the excess amount shall be credited to 

13 the appropriation account of the Food and Drug Ad14 ministration as provided in paragraph (1), and shall 

15 be subtracted from the amount of fees that would oth16 erwise be authorized to be collected under this section 

17 pursuant to appropriation Acts for fiscal year 2018. 

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

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

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

22 Government subject to subchapter II of chapter 37 of title 

23 31, United States Code. 

24 ‘‘(i) WRITTEN REQUESTS FOR WAIVERS, REDUCTIONS, 

25 AND REFUNDS.—To qualify for consideration for a waiver 


sroberts on DSK5SPTVN1PROD with BILLS
52 

•HR 1407 RH

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

2 fee collected in accordance with subsection (a), a person 

3 shall submit to the Secretary a written request for such 

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

5 such fee is due. 

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

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

10 engaged in the process of the review of abbreviated applica11 tions for generic new animal drugs, be reduced to offset the 

12 number of officers, employees, and advisory committees so 

13 engaged. 

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

15 ‘‘(1) ABBREVIATED APPLICATION FOR A GENERIC

16 NEW ANIMAL DRUG.—The terms ‘abbreviated applica17 tion for a generic new animal drug’ and ‘abbreviated 

18 application’ mean an abbreviated application for the 

19 approval of any generic new animal drug submitted 

20 under section 512(b)(2). Such term does not include 

21 a supplemental abbreviated application for a generic 

22 new animal drug. 

23 ‘‘(2) ADJUSTMENT FACTOR.—The term ‘adjust24 ment factor’ applicable to a fiscal year is the Con25 sumer Price Index for all urban consumers (all items; 


sroberts on DSK5SPTVN1PROD with BILLS
53 

•HR 1407 RH

1 United States city average) for October of the pre2 ceding fiscal year divided by— 

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

4 Index for October 2002; and 

5 ‘‘(B) for purposes of subsection (g)(2)(A)(ii), 

6 such Index for October 2007. 

7 ‘‘(3) COSTS OF RESOURCES ALLOCATED FOR THE

8 PROCESS FOR THE REVIEW OF ABBREVIATED APPLI9 CATIONS FOR GENERIC NEW ANIMAL DRUGS.—The 

10 term ‘costs of resources allocated for the process for the 

11 review of abbreviated applications for generic new 

12 animal drugs’ means the expenses in connection with 

13 the process for the review of abbreviated applications 

14 for generic new animal drugs for— 

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

16 Drug Administration, contractors of the Food 

17 and Drug Administration, advisory committees 

18 consulted with respect to the review of specific 

19 abbreviated applications, supplemental abbre20 viated applications, or investigational submis21 sions, and costs related to such officers, employ22 ees, committees, and contractors, including costs 

23 for travel, education, and recruitment and other 

24 personnel activities; 


sroberts on DSK5SPTVN1PROD with BILLS
54 

•HR 1407 RH

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 equip7 ment, and other necessary materials and sup8 plies; and 

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

10 accounting for resources allocated for the review 

11 of abbreviated applications, supplemental abbre12 viated applications, and investigational submis13 sions. 

14 ‘‘(4) FINAL DOSAGE FORM.—The term ‘final dos15 age form’ means, with respect to a generic new ani16 mal drug product, a finished dosage form which is 

17 approved for administration to an animal without 

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

20 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 


sroberts on DSK5SPTVN1PROD with BILLS
55 

•HR 1407 RH

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 person 

15 who has submitted an investigational submission for 

16 a generic new animal drug that has not been termi17 nated or otherwise rendered inactive by the Secretary. 

18 ‘‘(8) INVESTIGATIONAL SUBMISSION FOR A GE19 NERIC NEW ANIMAL DRUG.—The terms ‘investiga20 tional submission for a generic new animal drug’ and 

21 ‘investigational submission’ mean— 

22 ‘‘(A) the filing of a claim for an investiga23 tional exemption under section 512(j) for a ge24 neric new animal drug intended to be the subject 


sroberts on DSK5SPTVN1PROD with BILLS
56 

•HR 1407 RH

1 of an abbreviated application or a supplemental 

2 abbreviated application; or 

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

4 purpose of enabling the Secretary to evaluate the 

5 safety or effectiveness of a generic new animal 

6 drug in the event of the filing of an abbreviated 

7 application or supplemental abbreviated applica8 tion for such drug. 

9 ‘‘(9) PERSON.—The term ‘person’ includes an af10 filiate 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, sup18 plemental abbreviated applications, and investiga19 tional submissions: 

20 ‘‘(A) The activities necessary for the review 

21 of abbreviated applications, supplemental abbre22 viated applications, and investigational submis23 sions. 

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

25 approve abbreviated applications or suppleVerDate Mar 15 2010 22:04 Aug 02, 2013 Jkt 029200 PO 00000 Frm 00056 Fmt 6652 Sfmt 6203 E:\BILLS\H1407.RH H1407

sroberts on DSK5SPTVN1PROD with BILLS
57 

•HR 1407 RH

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 place 

6 such applications, supplemental applications, or 

7 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 products 

23 subject to review. 

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

25 generic new animal drug sponsor. 


sroberts on DSK5SPTVN1PROD with BILLS
58 

•HR 1407 RH

1 ‘‘(H) Review of advertising and labeling 

2 prior to approval of an abbreviated application 

3 or supplemental abbreviated application, but not 

4 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 approve 

10 a change in an approved abbreviated application.’’. 

11 SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS. 

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

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

14 ‘‘SEC. 742. REAUTHORIZATION; REPORTING REQUIRE15 MENTS. 

16 ‘‘(a) PERFORMANCE REPORTS.—Beginning with fiscal 

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

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

19 the Secretary shall prepare and submit to the Committee 

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

21 and the Committee on Energy and Commerce of the House 

22 of Representatives a report concerning the progress of the 

23 Food and Drug Administration in achieving the goals iden24 tified in the letters described in section 201(b) of the Animal 

25 Generic Drug User Fee Amendments of 2013 toward expeVerDate Mar 15 2010 22:04 Aug 02, 2013 Jkt 029200 PO 00000 Frm 00058 Fmt 6652 Sfmt 6203 E:\BILLS\H1407.RH H1407

sroberts on DSK5SPTVN1PROD with BILLS
59 

•HR 1407 RH

1 diting the generic new animal drug development process 

2 and the review of abbreviated applications for generic new 

3 animal drugs, supplemental abbreviated applications for 

4 generic new animal drugs, and investigational submissions 

5 for generic new animal drugs during such fiscal year. 

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

7 2014, not later than 120 days after the end of each fiscal 

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

9 Secretary shall prepare and submit to the Committee on 

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

11 the Committee on Energy and Commerce of the House of 

12 Representatives a report on the implementation of the au13 thority for such fees during such fiscal year and the use, 

14 by the Food and Drug Administration, of the fees collected 

15 during such fiscal year for which the report is made. 

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

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

18 to the public on the Internet Web site of the Food and Drug 

19 Administration. 

20 ‘‘(d) REAUTHORIZATION.— 

21 ‘‘(1) CONSULTATION.—In developing rec22 ommendations to present to Congress with respect to 

23 the goals, and plans for meeting the goals, for the 

24 process for the review of abbreviated applications for 

25 generic new animal drugs for the first 5 fiscal years 


sroberts on DSK5SPTVN1PROD with BILLS
60 

•HR 1407 RH

1 after fiscal year 2018, and for the reauthorization of 

2 this part for such fiscal years, the Secretary shall con3 sult with— 

4 ‘‘(A) the Committee on Energy and Com5 merce of the House of Representatives; 

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

7 Labor, and Pensions of the Senate; 

8 ‘‘(C) scientific and academic experts; 

9 ‘‘(D) veterinary professionals; 

10 ‘‘(E) representatives of patient and con11 sumer advocacy groups; and 

12 ‘‘(F) the regulated industry. 

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

14 negotiations with the regulated industry on the reau15 thorization of this part, the Secretary shall— 

16 ‘‘(A) publish a notice in the Federal Reg17 ister requesting public input on the reauthoriza18 tion; 

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

20 public may present its views on the reauthoriza21 tion, including specific suggestions for changes to 

22 the goals referred to in subsection (a); 

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

24 public meeting to obtain written comments from 

25 the public suggesting changes to this part; and 


sroberts on DSK5SPTVN1PROD with BILLS
61 

•HR 1407 RH

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

2 Drug Administration’s Internet Web site. 

3 ‘‘(3) PERIODIC CONSULTATION.—Not less fre4 quently than once every 4 months during negotiations 

5 with the regulated industry, the Secretary shall hold 

6 discussions with representatives of veterinary, patient, 

7 and consumer advocacy groups to continue discus8 sions of their views on the reauthorization and their 

9 suggestions for changes to this part as expressed 

10 under paragraph (2). 

11 ‘‘(4) PUBLIC REVIEW OF RECOMMENDATIONS.— 

12 After negotiations with the regulated industry, the 

13 Secretary shall— 

14 ‘‘(A) present the recommendations developed 

15 under paragraph (1) to the congressional com16 mittees specified in such paragraph; 

17 ‘‘(B) publish such recommendations in the 

18 Federal Register; 

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

20 public to provide written comments on such rec21 ommendations; 

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

23 may present its views on such recommendations; 

24 and 


sroberts on DSK5SPTVN1PROD with BILLS
62 

•HR 1407 RH

1 ‘‘(E) after consideration of such public 

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

4 ‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.—Not 

5 later than January 15, 2018, the Secretary shall 

6 transmit to Congress the revised recommendations 

7 under paragraph (4), a summary of the views and 

8 comments received under such paragraph, and any 

9 changes made to the recommendations in response to 

10 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 Sec15 retary shall make publicly available, on the 

16 Internet Web site of the Food and Drug Admin17 istration, minutes of all negotiation meetings 

18 conducted under this subsection between the Food 

19 and Drug Administration and the regulated in20 dustry. 

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 


sroberts on DSK5SPTVN1PROD with BILLS
63 

•HR 1407 RH

1 or differences of opinion during the negotiations 

2 and their resolution.’’. 

3 SEC. 204. SAVINGS CLAUSE. 

4 Notwithstanding the amendments made by this title, 

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

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

7 date of enactment of this title, shall continue to be in effect 

8 with respect to abbreviated applications for a generic new 

9 animal drug and supplemental abbreviated applications for 

10 a generic new animal drug (as defined in such part as of 

11 such day) that on or after October 1, 2008, but before Octo12 ber 1, 2013, were accepted by the Food and Drug Adminis13 tration for filing with respect to assessing and collecting 

14 any fee required by such part for a fiscal year prior to fiscal 

15 year 2014. 

16 SEC. 205. EFFECTIVE DATE. 

17 The amendments made by this title shall take effect 

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

19 whichever is later, except that fees under part 5 of sub20 chapter C of chapter VII of the Federal Food, Drug, and 

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

22 all abbreviated applications for a generic new animal drug 

23 and supplemental abbreviated applications for a generic 

24 new animal drug received on or after October 1, 2013, re25 gardless of the date of enactment of this title. 


sroberts on DSK5SPTVN1PROD with BILLS
64 

•HR 1407 RH

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. 379j– 

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

8 (c) PREVIOUS SUNSET PROVISION.— 

9 (1) IN GENERAL.—Section 204 of the Animal Ge10 neric Drug User Fee Act of 2008 (Public Law 110– 

11 316) is repealed. 

12 (2) CONFORMING AMENDMENT.—Public Law 

13 110–316 (122 Stat. 3509) is amended in the table of 

14 contents in section 1, by striking the item relating to 

15 section 204. 

Amend the title so as to read: ‘‘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.’’. 


sroberts on DSK5SPTVN1PROD with BILLS

sroberts on DSK5SPTVN1PROD with BILLS
Union Calendar No. 135 

113TH CONGRESS 

1ST SESSION H. R. 1407 

[Report No. 113–188] 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

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

AUGUST 2, 2013 

Reported with amendments, committed to the Committee 

dered to be printed of the Whole House on the State of the Union, and orVerDate Mar 15 2010 22:04 Aug 02, 2013 Jkt 029200 PO 00000 Frm 00066 Fmt 6651 Sfmt 6651 E:\BILLS\H1407.RH H1407

sroberts on DSK5SPTVN1PROD with BILLS