I 

113TH CONGRESS 

1ST SESSION H. R. 1408 

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

fee programs relating to generic new animal drugs. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 9, 2013 

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

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

A BILL 

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

reauthorize user fee programs relating to 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; FINDING. 

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

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

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

7 be dedicated toward expediting the generic new animal 

8 drug development process and the review of abbreviated 

9 applications for generic new animal drugs, supplemental 


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1 abbreviated applications for generic new animal drugs, 

2 and investigational submissions for generic new animal 

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

4 the Secretary of Health and Human Services to the Chair5 man of the Committee on Energy and Commerce of the 

6 House of Representatives and the Chairman of the Com7 mittee on Health, Education, Labor, and Pensions of the 

8 Senate as set forth in the Congressional Record. 

9 SEC. 2. AUTHORITY TO ASSESS AND USE GENERIC NEW 

10 ANIMAL DRUG FEES. 

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

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

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

14 ANIMAL DRUG FEES. 

15 ‘‘(a) TYPES OF FEES.—Beginning with respect to fis16 cal year 2009, the Secretary shall assess and collect fees 

17 in accordance with this section as follows: 

18 ‘‘(1) ABBREVIATED APPLICATION FEE.— 

19 ‘‘(A) IN GENERAL.—Each person that sub20 mits, on or after July 1, 2008, an abbreviated 

21 application for a generic new animal drug shall 

22 be subject to a fee as established in subsection 

23 (c) for such an application. 


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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 for an 

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

20 and submitted on or after October 1, 2013, 

21 shall be subject to a fee equal to 50 per22 cent of the amount of the abbreviated ap23 plication fee established in subsection (c). 

24 ‘‘(D) REFUND OF FEE IF APPLICATION RE25 FUSED FOR FILING.—The Secretary shall reVerDate Mar 15 2010 03:24 Apr 11, 2013 Jkt 029200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1408.IH H1408

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1 fund 75 percent of the fee paid under subpara2 graph (B) for any abbreviated application which 

3 is refused for filing. 

4 ‘‘(E) REFUND OF FEE IF APPLICATION

5 WITHDRAWN.—If an abbreviated application is 

6 withdrawn after the application was filed, the 

7 Secretary may refund the fee or portion of the 

8 fee paid under subparagraph (B) if no substan9 tial work was performed on the application 

10 after the application was filed. The Secretary 

11 shall have the sole discretion to refund the fee 

12 under this subparagraph. A determination by 

13 the Secretary concerning a refund under this 

14 subparagraph shall not be reviewable. 

15 ‘‘(2) GENERIC NEW ANIMAL DRUG PRODUCT

16 FEE.— 

17 ‘‘(A) IN GENERAL.—Each person— 

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

19 an abbreviated application or supplemental 

20 abbreviated application for a generic new 

21 animal drug product which has been sub22 mitted for listing under section 510; and 

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

24 had pending before the Secretary an abbreVerDate Mar 15 2010 03:24 Apr 11, 2013 Jkt 029200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1408.IH H1408

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1 viated application or supplemental abbre2 viated application, 

3 shall pay for each such generic new animal 

4 drug product the annual fee established in sub5 section (c). 

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

7 shall be payable for the fiscal year in which the 

8 generic new animal drug product is first sub9 mitted for listing under section 510, or is sub10 mitted for relisting under section 510 if the ge11 neric new animal drug product has been with12 drawn from listing and relisted. After such fee 

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

14 each subsequent fiscal year that the product re15 mains listed, upon the later of— 

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

17 date of enactment of an appropriations Act 

18 providing for the collection and obligation 

19 of fees for such fiscal year under this sec20 tion; or 

21 ‘‘(ii) January 31 of each year. 

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

23 only once for each generic new animal drug 

24 product for a fiscal year in which the fee is pay25 able. 


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1 ‘‘(3) GENERIC NEW ANIMAL DRUG SPONSOR

2 FEE.— 

3 ‘‘(A) IN GENERAL.—Each person— 

4 ‘‘(i) who meets the definition of a ge5 neric new animal drug sponsor within a 

6 fiscal year; and 

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

8 had pending before the Secretary an abbre9 viated application, a supplemental abbre10 viated application, or an investigational 

11 submission, 

12 shall be assessed an annual generic new animal 

13 drug sponsor fee as established under sub14 section (c). 

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

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

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

18 date of enactment of an appropriations Act 

19 providing for the collection and obligation 

20 of fees for such fiscal year under this sec21 tion; or 

22 ‘‘(ii) January 31 of each year. 

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

24 animal drug sponsor shall pay only 1 such fee 

25 each fiscal year, as follows: 


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

2 generic new animal drug sponsor fee pub3 lished for that fiscal year under subsection 

4 (c) for an applicant with more than 6 ap5 proved abbreviated applications. 

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

7 generic new animal drug sponsor fee pub8 lished for that fiscal year under subsection 

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

10 fewer than 7 approved abbreviated applica11 tions. 

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

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

15 (c) for an applicant with 1 or fewer ap16 proved abbreviated applications. 

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

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

19 be established to generate fee revenue amounts as follows: 

20 ‘‘(1) TOTAL FEE REVENUES FOR APPLICATION

21 FEES.—The total fee revenues to be collected in ab22 breviated application fees under subsection (a)(1) 

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

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


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

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

3 ‘‘(2) TOTAL FEE REVENUES FOR PRODUCT

4 FEES.—The total fee revenues to be collected in ge5 neric new animal drug product fees under subsection 

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

7 $2,604,000 for fiscal year 2015, $2,786,000 for fis8 cal year 2016, $2,976,000 for fiscal year 2017, and 

9 $3,175,000 for fiscal year 2018. 

10 ‘‘(3) TOTAL FEE REVENUES FOR SPONSOR

11 FEES.—The total fee revenues to be collected in ge12 neric new animal drug sponsor fees under subsection 

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

14 $2,604,000 for fiscal year 2015, $2,786,000 for fis15 cal year 2016, $2,976,000 for fiscal year 2017, and 

16 $3,175,000 for fiscal year 2018. 

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

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

19 shall establish, 60 days before the start of each fis20 cal year beginning after September 30, 2008, for 

21 that fiscal year, abbreviated application fees, generic 

22 new animal drug sponsor fees, and generic new ani23 mal drug product fees, based on the revenue 

24 amounts established under subsection (b) and the 

25 adjustments provided under this subsection. 


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1 ‘‘(2) WORKLOAD ADJUSTMENT.—The fee reve2 nues shall be adjusted each fiscal year after fiscal 

3 year 2014 to reflect changes in review workload. 

4 With respect to such adjustment: 

5 ‘‘(A) This adjustment shall be determined 

6 by the Secretary based on a weighted average 

7 of the change in the total number of abbre8 viated applications for generic new animal 

9 drugs, manufacturing supplemental abbreviated 

10 applications for generic new animal drugs, in11 vestigational generic new animal drug study 

12 submissions, and investigational generic new 

13 animal drug protocol submissions submitted to 

14 the Secretary. The Secretary shall publish in 

15 the Federal Register the fees resulting from 

16 this adjustment and the supporting methodolo17 gies. 

18 ‘‘(B) Under no circumstances shall this 

19 workload adjustment result in fee revenues for 

20 a fiscal year that are less than the fee revenues 

21 for that fiscal year established in subsection 

22 (b). 

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

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

25 adjustments under this subsection, further increase 


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

2 necessary, to provide for up to 3 months of oper3 ating reserves of carryover user fees for the process 

4 for the review of abbreviated applications for generic 

5 new animal drugs for the first 3 months of fiscal 

6 year 2019. If the Food and Drug Administration 

7 has carryover balances for the process for the review 

8 of abbreviated applications for generic new animal 

9 drugs in excess of 3 months of such operating re10 serves, then this adjustment shall not be made. If 

11 this adjustment is necessary, then the rationale for 

12 the amount of the increase shall be contained in the 

13 annual notice setting fees for fiscal year 2018. 

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

15 as adjusted under this subsection, for a fiscal year 

16 may not exceed the total costs for such fiscal year 

17 for the resources allocated for the process for the re18 view of abbreviated applications for generic new ani19 mal drugs. 

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

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

22 assessed under subsection (a) where the Secretary finds 

23 that the generic new animal drug is intended solely to pro24 vide for a minor use or minor species indication. 


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1 ‘‘(e) EFFECT OF FAILURE TO PAY FEES.—An abbre2 viated application for a generic new animal drug sub3 mitted by a person subject to fees under subsection (a) 

4 shall be considered incomplete and shall not be accepted 

5 for filing by the Secretary until all fees owed by such per6 son have been paid. An investigational submission for a 

7 generic new animal drug that is submitted by a person 

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

9 incomplete and shall not be accepted for review by the Sec10 retary until all fees owed by such person have been paid. 

11 The Secretary may discontinue review of any abbreviated 

12 application for a generic new animal drug, supplemental 

13 abbreviated application for a generic new animal drug, or 

14 investigational submission for a generic new animal drug 

15 from a person if such person has not submitted for pay16 ment all fees owed under this section by 30 days after 

17 the date upon which they are due. 

18 ‘‘(f) ASSESSMENT OF FEES.— 

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

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

21 fiscal year 2008 unless appropriations for salaries 

22 and expenses of the Food and Drug Administration 

23 for such fiscal year (excluding the amount of fees 

24 appropriated for such fiscal year) are equal to or 

25 greater than the amount of appropriations for the 


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1 salaries and expenses of the Food and Drug Admin2 istration for the fiscal year 2003 (excluding the 

3 amount of fees appropriated for such fiscal year) 

4 multiplied by the adjustment factor applicable to the 

5 fiscal year involved. 

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

7 assess fees under subsection (a) during any portion 

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

9 a later date in such fiscal year the Secretary may as10 sess such fees, the Secretary may assess and collect 

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

12 abbreviated applications, generic new animal drug 

13 sponsors, and generic new animal drug products at 

14 any time in such fiscal year notwithstanding the pro15 visions of subsection (a) relating to the date fees are 

16 to be paid. 

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

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

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

20 collected and available for obligation only to the ex21 tent and in the amount provided in advance in ap22 propriations Acts. Such fees are authorized to be ap23 propriated to remain available until expended. Such 

24 sums as may be necessary may be transferred from 

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1 penses appropriation account without fiscal year lim2 itation to such appropriation account for salary and 

3 expenses with such fiscal year limitation. The sums 

4 transferred shall be available solely for the process 

5 for the review of abbreviated applications for generic 

6 new animal drugs. 

7 ‘‘(2) COLLECTIONS AND APPROPRIATION

8 ACTS.— 

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

10 by this section— 

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

12 be collected and available in each fiscal 

13 year in an amount not to exceed the 

14 amount specified in appropriation Acts, or 

15 otherwise made available for obligation for 

16 such fiscal year; and 

17 ‘‘(ii) shall be available to defray in18 creases in the costs of the resources allo19 cated for the process for the review of ab20 breviated applications for generic new ani21 mal drugs (including increases in such 

22 costs for an additional number of full-time 

23 equivalent positions in the Department of 

24 Health and Human Services to be engaged 

25 in such process) over such costs, excluding 


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1 costs paid from fees collected under this 

2 section, for fiscal year 2008 multiplied by 

3 the adjustment factor. 

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

5 be considered to have met the requirements of 

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

7 costs funded by appropriations and allocated for 

8 the process for the review of abbreviated appli9 cations for generic new animal drugs— 

10 ‘‘(i) are not more than 3 percent 

11 below the level specified in subparagraph 

12 (A)(ii); or 

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

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

15 and fees assessed for the fiscal year fol16 lowing the subsequent fiscal year are de17 creased by the amount in excess of 3 per18 cent by which such costs fell below the 

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

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

21 percent below the level specified in sub22 paragraph (A)(ii). 

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

24 Payment of fees authorized under this section 

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


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1 fees, may be accepted by the Secretary in ac2 cordance with authority provided in advance in 

3 a prior year appropriations Act. 

4 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

5 There are authorized to be appropriated for fees 

6 under this section— 

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

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

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

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

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

12 as adjusted to reflect adjustments in the total fee 

13 revenues made under this section and changes in the 

14 total amounts collected by abbreviated application 

15 fees, generic new animal drug sponsor fees, and ge16 neric new animal drug product fees. 

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

18 amount of fees collected under this section for the 

19 fiscal years 2014 through 2016 and the amount of 

20 fees estimated to be collected under this section for 

21 fiscal year 2017 exceeds the cumulative amount ap22 propriated under paragraph (3) for the fiscal years 

23 2014 through 2017, the excess amount shall be 

24 credited to the appropriation account of the Food 

25 and Drug Administration as provided in paragraph 


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

2 that would otherwise be authorized to be collected 

3 under this section pursuant to appropriation Acts 

4 for fiscal year 2018. 

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

6 where the Secretary does not receive payment of a fee as7 sessed under subsection (a) within 30 days after it is due, 

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

9 Government subject to subchapter II of chapter 37 of title 

10 31, United States Code. 

11 ‘‘(i) WRITTEN REQUESTS FOR WAIVERS, REDUC12 TIONS, AND REFUNDS.—To qualify for consideration for 

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

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

15 person shall submit to the Secretary a written request for 

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

17 after such fee is due. 

18 ‘‘(j) CONSTRUCTION.—This section may not be con19 strued to require that the number of full-time equivalent 

20 positions in the Department of Health and Human Serv21 ices, for officers, employees, and advisory committees not 

22 engaged in the process of the review of abbreviated appli23 cations for generic new animal drugs, be reduced to offset 

24 the number of officers, employees, and advisory commit25 tees so engaged. 


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

2 ‘‘(1) ABBREVIATED APPLICATION FOR A GE3 NERIC NEW ANIMAL DRUG.—The terms ‘abbreviated 

4 application for a generic new animal drug’ and ‘ab5 breviated application’ mean an abbreviated applica6 tion for the approval of any generic new animal drug 

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

8 not include a supplemental abbreviated application 

9 for a generic new animal drug. 

10 ‘‘(2) ADJUSTMENT FACTOR.—The term ‘adjust11 ment factor’ applicable to a fiscal year is the Con12 sumer Price Index for all urban consumers (all 

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

14 preceding fiscal year divided by— 

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

16 such Index for October 2002; and 

17 ‘‘(B) for purposes of subsection 

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

19 ‘‘(3) COSTS OF RESOURCES ALLOCATED FOR

20 THE PROCESS FOR THE REVIEW OF ABBREVIATED

21 APPLICATIONS FOR GENERIC NEW ANIMAL DRUGS.— 

22 The term ‘costs of resources allocated for the proc23 ess for the review of abbreviated applications for ge24 neric new animal drugs’ means the expenses in con25 nection with the process for the review of abbreVerDate Mar 15 2010 03:24 Apr 11, 2013 Jkt 029200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\H1408.IH H1408

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1 viated applications for generic new animal drugs 

2 for— 

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

4 and Drug Administration, contractors of the 

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

7 specific abbreviated applications, supplemental 

8 abbreviated applications, or investigational sub9 missions, and costs related to such officers, em10 ployees, committees, and contractors, including 

11 costs for travel, education, and recruitment and 

12 other personnel activities; 

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

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

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

17 repair of facilities and acquisition, maintenance, 

18 and repair of fixtures, furniture, scientific 

19 equipment, and other necessary materials and 

20 supplies; and 

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

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

24 abbreviated applications, and investigational 

25 submissions. 


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

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

3 animal drug product, a finished dosage form which 

4 is approved for administration to an animal without 

5 substantial further manufacturing. Such term in6 cludes generic new animal drug products intended 

7 for mixing in animal feeds. 

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

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

10 that is the subject of an abbreviated application. 

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

12 The term ‘generic new animal drug product’ means 

13 each specific strength or potency of a particular ac14 tive ingredient or ingredients in final dosage form 

15 marketed by a particular manufacturer or dis16 tributor, which is uniquely identified by the labeler 

17 code and product code portions of the national drug 

18 code, and for which an abbreviated application for a 

19 generic new animal drug or a supplemental abbre20 viated application has been approved. 

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

22 The term ‘generic new animal drug sponsor’ means 

23 either an applicant named in an abbreviated applica24 tion for a generic new animal drug that has not been 

25 withdrawn by the applicant and for which approval 


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1 has not been withdrawn by the Secretary, or a per2 son who has submitted an investigational submission 

3 for a generic new animal drug that has not been ter4 minated or otherwise rendered inactive by the Sec5 retary. 

6 ‘‘(8) INVESTIGATIONAL SUBMISSION FOR A GE7 NERIC NEW ANIMAL DRUG.—The terms ‘investiga8 tional submission for a generic new animal drug’ 

9 and ‘investigational submission’ mean— 

10 ‘‘(A) the filing of a claim for an investiga11 tional exemption under section 512(j) for a ge12 neric new animal drug intended to be the sub13 ject of an abbreviated application or a supple14 mental abbreviated application; or 

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

16 purpose of enabling the Secretary to evaluate 

17 the safety or effectiveness of a generic new ani18 mal drug in the event of the filing of an abbre19 viated application or supplemental abbreviated 

20 application for such drug. 

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

22 affiliate thereof (as such term is defined in section 

23 735(11)). 

24 ‘‘(10) PROCESS FOR THE REVIEW OF ABBRE25 VIATED APPLICATIONS FOR GENERIC NEW ANIMAL


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1 DRUGS.—The term ‘process for the review of abbre2 viated applications for generic new animal drugs’ 

3 means the following activities of the Secretary with 

4 respect to the review of abbreviated applications, 

5 supplemental abbreviated applications, and inves6 tigational submissions: 

7 ‘‘(A) The activities necessary for the re8 view of abbreviated applications, supplemental 

9 abbreviated applications, and investigational 

10 submissions. 

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

12 approve abbreviated applications or supple13 mental abbreviated applications or which set 

14 forth in detail the specific deficiencies in abbre15 viated applications, supplemental abbreviated 

16 applications, or investigational submissions and, 

17 where appropriate, the actions necessary to 

18 place such applications, supplemental applica19 tions, or submissions in condition for approval. 

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

21 drug establishments and other facilities under22 taken as part of the Secretary’s review of pend23 ing abbreviated applications, supplemental ab24 breviated applications, and investigational sub25 missions. 


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1 ‘‘(D) Monitoring of research conducted in 

2 connection with the review of abbreviated appli3 cations, supplemental abbreviated applications, 

4 and investigational submissions. 

5 ‘‘(E) The development of regulations and 

6 policy related to the review of abbreviated appli7 cations, supplemental abbreviated applications, 

8 and investigational submissions. 

9 ‘‘(F) Development of standards for prod10 ucts subject to review. 

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

12 generic new animal drug sponsor. 

13 ‘‘(H) Review of advertising and labeling 

14 prior to approval of an abbreviated application 

15 or supplemental abbreviated application, but 

16 not after such application has been approved. 

17 ‘‘(11) SUPPLEMENTAL ABBREVIATED APPLICA18 TION FOR GENERIC NEW ANIMAL DRUG.—The terms 

19 ‘supplemental abbreviated application for a generic 

20 new animal drug’ and ‘supplemental abbreviated ap21 plication’ mean a request to the Secretary to ap22 prove a change in an approved abbreviated applica23 tion.’’. 


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1 SEC. 3. REAUTHORIZATION; REPORTING REQUIREMENTS. 

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

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

4 ‘‘SEC. 742. REAUTHORIZATION; REPORTING REQUIRE5 MENTS. 

6 ‘‘(a) PERFORMANCE REPORTS.—Beginning with fis7 cal year 2014, not later than 120 days after the end of 

8 each fiscal year during which fees are collected under this 

9 part, the Secretary shall prepare and submit to the Com10 mittee on Health, Education, Labor, and Pensions of the 

11 Senate, and the Committee on Energy and Commerce of 

12 the House of Representatives a report concerning the 

13 progress of the Food and Drug Administration in achiev14 ing the goals identified in the letters described in section 

15 1(b) of the Animal Generic Drug User Fee Amendments 

16 of 2013 toward expediting the generic new animal drug 

17 development process and the review of abbreviated appli18 cations for generic new animal drugs, supplemental abbre19 viated applications for generic new animal drugs, and in20 vestigational submissions for generic new animal drugs 

21 during such fiscal year. 

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

23 2014, not later than 120 days after the end of each fiscal 

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

25 Secretary shall prepare and submit to the Committee on 

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


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1 the Committee on Energy and Commerce of the House 

2 of Representatives a report on the implementation of the 

3 authority for such fees during such fiscal year and the 

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

5 collected during such fiscal year for which the report is 

6 made. 

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

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

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

10 Food and Drug Administration. 

11 ‘‘(d) REAUTHORIZATION.— 

12 ‘‘(1) CONSULTATION.—In developing rec13 ommendations to present to Congress with respect to 

14 the goals, and plans for meeting the goals, for the 

15 process for the review of abbreviated applications for 

16 generic new animal drugs for the first 5 fiscal years 

17 after fiscal year 2018, and for the reauthorization of 

18 this part for such fiscal years, the Secretary shall 

19 consult with— 

20 ‘‘(A) the Committee on Energy and Com21 merce of the House of Representatives; 

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

23 Labor, and Pensions of the Senate; 

24 ‘‘(C) scientific and academic experts; 

25 ‘‘(D) veterinary professionals; 


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1 ‘‘(E) representatives of patient and con2 sumer advocacy groups; and 

3 ‘‘(F) the regulated industry. 

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

5 negotiations with the regulated industry on the reau6 thorization of this part, the Secretary shall— 

7 ‘‘(A) publish a notice in the Federal Reg8 ister requesting public input on the reauthoriza9 tion; 

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

11 public may present its views on the reauthoriza12 tion, including specific suggestions for changes 

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

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

15 public meeting to obtain written comments from 

16 the public suggesting changes to this part; and 

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

18 and Drug Administration’s Internet Web site. 

19 ‘‘(3) PERIODIC CONSULTATION.—Not less fre20 quently than once every 4 months during negotia21 tions with the regulated industry, the Secretary shall 

22 hold discussions with representatives of veterinary, 

23 patient, and consumer advocacy groups to continue 

24 discussions of their views on the reauthorization and 


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1 their suggestions for changes to this part as ex2 pressed under paragraph (2). 

3 ‘‘(4) PUBLIC REVIEW OF RECOMMENDA4 TIONS.—After negotiations with the regulated indus5 try, the Secretary shall— 

6 ‘‘(A) present the recommendations devel7 oped under paragraph (1) to the congressional 

8 committees specified in such paragraph; 

9 ‘‘(B) publish such recommendations in the 

10 Federal Register; 

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

12 the public to provide written comments on such 

13 recommendations; 

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

15 may present its views on such recommenda16 tions; and 

17 ‘‘(E) after consideration of such public 

18 views and comments, revise such recommenda19 tions as necessary. 

20 ‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.— 

21 Not later than January 15, 2018, the Secretary 

22 shall transmit to Congress the revised recommenda23 tions under paragraph (4), a summary of the views 

24 and comments received under such paragraph, and 


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1 any changes made to the recommendations in re2 sponse to such views and comments. 

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

4 ‘‘(A) PUBLIC AVAILABILITY.—Before pre5 senting the recommendations developed under 

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

7 Secretary shall make publicly available, on the 

8 Internet Web site of the Food and Drug Ad9 ministration, minutes of all negotiation meet10 ings conducted under this subsection between 

11 the Food and Drug Administration and the reg12 ulated industry. 

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

14 under subparagraph (A) shall summarize any 

15 substantive proposal made by any party to the 

16 negotiations as well as significant controversies 

17 or differences of opinion during the negotiations 

18 and their resolution.’’. 

19 SEC. 4. SAVINGS CLAUSE. 

20 Notwithstanding the amendments made by this Act, 

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

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

23 the date of enactment of this Act, shall continue to be 

24 in effect with respect to abbreviated applications for a ge25 neric new animal drug and supplemental abbreviated apVerDate Mar 15 2010 03:24 Apr 11, 2013 Jkt 029200 PO 00000 Frm 00027 Fmt 6652 Sfmt 6201 E:\BILLS\H1408.IH H1408

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1 plications for a generic new animal drug (as defined in 

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

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

4 and Drug Administration for filing with respect to assess5 ing and collecting any fee required by such part for a fiscal 

6 year prior to fiscal year 2014. 

7 SEC. 5. EFFECTIVE DATE. 

8 The amendments made by this Act shall take effect 

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

10 whichever is later, except that fees under part 5 of sub11 chapter C of chapter VII of the Federal Food, Drug, and 

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

13 for all abbreviated applications for a generic new animal 

14 drug and supplemental abbreviated applications for a ge15 neric new animal drug received on or after October 1, 

16 2013, regardless of the date of enactment of this Act. 

17 SEC. 6. SUNSET DATES. 

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

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

20 cease to be effective October 1, 2018. 

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

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

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

24 (c) PREVIOUS SUNSET PROVISION.— 


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

2 Generic Drug User Fee Act of 2008 (Public Law 

3 110–316) is repealed. 

4 (2) CONFORMING AMENDMENT.—The Animal 

5 Generic Drug User Fee Act of 2008 (Public Law 

6 110–316) is amended in the table of contents in sec7 tion 1, by striking the item relating to section 204. 

Æ 


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