I 

112TH CONGRESS 

2D SESSION H. R. 3988 

To amend the Federal Food, Drug, and Cosmetic Act to establish userfee programs for generic drugs and biosimilars. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 8, 2012 

Mr. MURPHY of Pennsylvania (for himself, Mr. PALLONE, Mr. PITTS, and Mr. 

WAXMAN) 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 

establish user-fee programs for generic drugs and biosimilars. 

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; TABLE OF CONTENTS. 

4 This Act may be cited as the ‘‘Generic Drug and Bio5 similar User Fee Act of 2012’’. 

6 SEC. 2. TABLE OF CONTENTS. 

7 The table of contents for this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Table of contents. 

TITLE I—FEES RELATING TO GENERIC DRUGS 

Sec. 101. Short title; references in title; findings. 


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Sec. 102. Authority to assess and use human generic drug fees. 

Sec. 103. Reauthorization; reporting requirements. 

Sec. 104. Sunset dates. 

Sec. 105. Effective date. 

Sec. 106. Amendment with respect to misbranding. 

Sec. 107. Electronic submission of applications. 

Sec. 108. Streamlined hiring authority of the Food and Drug Administration 

to support activities related to human generic drugs. 

TITLE II—FEES RELATING TO BIOSIMILAR BIOLOGICAL 

PRODUCTS 

Sec. 201. Short title; references in title; finding. 

Sec. 202. Fees relating to biosimilar biological products. 

Sec. 203. Reauthorization; reporting requirements. 

Sec. 204. Sunset dates. 

Sec. 205. Effective date. 

Sec. 206. Savings clause. 

Sec. 207. Technical amendment; conforming amendment. 

1 TITLE I—FEES RELATING TO 

2 GENERIC DRUGS 

3 SEC. 101. SHORT TITLE; REFERENCES IN TITLE; FINDINGS. 

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

5 ‘‘Generic Drug User Fee Amendments of 2012’’. 

6 (b) REFERENCES IN ACT.—Except as otherwise spec7 ified, amendments made by this title to a section or other 

8 provision of law are amendments to such section or other 

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

10 (21 U.S.C. 301 et seq.). 

11 (c) FINDINGS.—The Congress finds that the fees au12 thorized by the amendments made in this title will be dedi13 cated, as set forth in the goals identified in the letters 

14 from the Secretary of Health and Human Services to the 

15 Chairman of the Committee on Health, Education, Labor, 

16 and Pensions of the Senate and the Chairman of the Com17 mittee on Energy and Commerce of the House of RepVerDate Mar 15 2010 04:33 Feb 09, 2012 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3988.IH H3988

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1 resentatives, as set forth in the Congressional Record. 

2 These fees are intended to help the Food and Drug Ad3 ministration ensure that participants in the United States 

4 generic drug system comply with United States quality 

5 standards, and to increase the likelihood that American 

6 consumers have timely access to low-cost, high-quality ge7 neric drugs. A comprehensive human generic drug user fee 

8 program, to be supplemental to traditional appropriated 

9 funding, should be focused on three key aims: 

10 (1) SAFETY.—Ensure that industry partici11 pants, foreign or domestic, who participate in the 

12 United States generic drug system are held to con13 sistent high-quality standards and are inspected bi14 ennially, using a risk-based approach, with foreign 

15 and domestic parity. 

16 (2) ACCESS.—Expedite the availability of low17 cost, high-quality generic drugs by bringing greater 

18 predictability to the review times for abbreviated 

19 new drug applications, amendments, and supple20 ments, increasing predictability and timeliness in the 

21 review process. 

22 (3) TRANSPARENCY.—Enhance the Food and 

23 Drug Administration’s ability to protect Americans 

24 in the complex global supply environment by requir25 ing the identification of facilities involved in the 


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1 manufacture of generic drugs and associated active 

2 pharmaceutical ingredients, and improving the Food 

3 and Drug Administration’s communications and 

4 feedback with industry in order to expedite product 

5 access. 

6 SEC. 102. AUTHORITY TO ASSESS AND USE HUMAN GE7 NERIC DRUG FEES. 

8 Subchapter C of chapter VII (21 U.S.C. 379f et seq.) 

9 is amended by adding at the end the following: 

10 ‘‘PART 7—FEES RELATING TO GENERIC DRUGS 

11 ‘‘SEC. 744A. DEFINITIONS. 

12 ‘‘For purposes of this part: 

13 ‘‘(1) The term ‘abbreviated new drug applica14 tion’— 

15 ‘‘(A) means an application submitted 

16 under section 505(j), an abbreviated application 

17 submitted under section 507 (as in effect on the 

18 day before the date of enactment of the Food 

19 and Drug Administration Modernization Act of 

20 1997), or an abbreviated new drug application 

21 submitted pursuant to regulations in effect 

22 prior to the implementation of the Drug Price 

23 Competition and Patent Term Restoration Act 

24 of 1984; and 


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1 ‘‘(B) does not include an application for a 

2 positron emission tomography drug. 

3 ‘‘(2) The term ‘active pharmaceutical ingre4 dient’ means— 

5 ‘‘(A) a substance, or a mixture when the 

6 substance is unstable or cannot be transported 

7 on its own, intended— 

8 ‘‘(i) to be used as a component of a 

9 drug; and 

10 ‘‘(ii) to furnish pharmacological activ11 ity or other direct effect in the diagnosis, 

12 cure, mitigation, treatment, or prevention 

13 of disease, or to affect the structure or any 

14 function of the human body; or 

15 ‘‘(B) a substance intended for final crys16 tallization, purification, or salt formation, or 

17 any combination of those activities, to become a 

18 substance or mixture described in subparagraph 

19 (A). 

20 ‘‘(3) The term ‘adjustment factor’ means a fac21 tor applicable to a fiscal year that is the Consumer 

22 Price Index for all urban consumers (all items; 

23 United States city average) for October of the pre24 ceding fiscal year divided by such Index for October 

25 2011. 


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1 ‘‘(4) The term ‘affiliate’ means a business enti2 ty that has a relationship with a second business en3 tity if, directly or indirectly— 

4 ‘‘(A) one business entity controls, or has 

5 the power to control, the other business entity; 

6 or 

7 ‘‘(B) a third party controls, or has power 

8 to control, both of the business entities. 

9 ‘‘(5)(A) The term ‘facility’— 

10 ‘‘(i) means a business or other entity— 

11 ‘‘(I) under one management, either di12 rect or indirect; and 

13 ‘‘(II) at one geographic location or ad14 dress engaged in manufacturing or proc15 essing an active pharmaceutical ingredient 

16 or a finished dosage form; and 

17 ‘‘(ii) does not include a business or other 

18 entity whose only manufacturing or processing 

19 activities are one or more of the following: re20 packaging, relabeling, or testing. 

21 ‘‘(B) For purposes of subparagraph (A), sepa22 rate buildings within close proximity are considered 

23 to be at one geographic location or address if the ac24 tivities in them are— 


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1 ‘‘(i) closely related to the same business 

2 enterprise; 

3 ‘‘(ii) under the supervision of the same 

4 local management; and 

5 ‘‘(iii) capable of being inspected by the 

6 Food and Drug Administration during a single 

7 inspection. 

8 ‘‘(C) If a business or other entity would meet 

9 the definition of a facility under this paragraph but 

10 for being under multiple management, the business 

11 or other entity is deemed to constitute multiple fa12 cilities, one per management entity, for purposes of 

13 this paragraph. 

14 ‘‘(6) The term ‘finished dosage form’ means— 

15 ‘‘(A) a drug product in the form in which 

16 it will be administered to a patient, such as a 

17 tablet, capsule, solution, or topical application; 

18 ‘‘(B) a drug product in a form in which re19 constitution is necessary prior to administration 

20 to a patient, such as oral suspensions or 

21 lyophilized powders; or 

22 ‘‘(C) any combination of an active pharma23 ceutical ingredient with another component of a 

24 drug product for purposes of production of a 


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1 drug product described in subparagraph (A) or 

2 (B). 

3 ‘‘(7) The term ‘generic drug submission’ means 

4 an abbreviated new drug application, an amendment 

5 to an abbreviated new drug application, or a prior 

6 approval supplement to an abbreviated new drug ap7 plication. 

8 ‘‘(8) The term ‘human generic drug activities’ 

9 means the following activities of the Secretary asso10 ciated with generic drugs and inspection of facilities 

11 associated with generic drugs: 

12 ‘‘(A) The activities necessary for the re13 view of generic drug submissions, including re14 view of drug master files referenced in such 

15 submissions. 

16 ‘‘(B) The issuance of— 

17 ‘‘(i) approval letters which approve 

18 abbreviated new drug applications or sup19 plements to such applications; or 

20 ‘‘(ii) complete response letters which 

21 set forth in detail the specific deficiencies 

22 in such applications and, where appro23 priate, the actions necessary to place such 

24 applications in condition for approval. 


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1 ‘‘(C) The issuance of letters related to 

2 Type II active pharmaceutical drug master files 

3 which— 

4 ‘‘(i) set forth in detail the specific de5 ficiencies in such submissions, and where 

6 appropriate, the actions necessary to re7 solve those deficiencies; or 

8 ‘‘(ii) document that no deficiencies 

9 need to be addressed. 

10 ‘‘(D) Inspections related to generic drugs. 

11 ‘‘(E) Monitoring of research conducted in 

12 connection with the review of generic drug sub13 missions and drug master files. 

14 ‘‘(F) Postmarket safety activities with re15 spect to drugs approved under abbreviated new 

16 drug applications or supplements, including the 

17 following activities: 

18 ‘‘(i) Collecting, developing, and re19 viewing safety information on approved 

20 drugs, including adverse event reports. 

21 ‘‘(ii) Developing and using improved 

22 adverse-event data-collection systems, in23 cluding information technology systems. 

24 ‘‘(iii) Developing and using improved 

25 analytical tools to assess potential safety 


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1 problems, including access to external data 

2 bases. 

3 ‘‘(iv) Implementing and enforcing sec4 tion 505(o) (relating to postapproval stud5 ies and clinical trials and labeling changes) 

6 and section 505(p) (relating to risk evalua7 tion and mitigation strategies) insofar as 

8 those activities relate to abbreviated new 

9 drug applications. 

10 ‘‘(v) Carrying out section 505(k)(5) 

11 (relating to adverse event reports and 

12 postmarket safety activities). 

13 ‘‘(G) Regulatory science activities related 

14 to generic drugs. 

15 ‘‘(9) The term ‘positron emission tomography 

16 drug’ has the meaning given to the term ‘com17 pounded positron emission tomography drug’ in sec18 tion 201(ii), except that paragraph (1)(B) of such 

19 section shall not apply. 

20 ‘‘(10) The term ‘prior approval supplement’ 

21 means a request to the Secretary to approve a 

22 change in the drug substance, drug product, produc23 tion process, quality controls, equipment, or facilities 

24 covered by an approved abbreviated new drug appli25 cation when that change has a substantial potential 


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1 to have an adverse effect on the identity, strength, 

2 quality, purity, or potency of the drug product as 

3 these factors may relate to the safety or effective4 ness of the drug product. 

5 ‘‘(11) The term ‘resources allocated for human 

6 generic drug activities’ means the expenses for— 

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

8 and Drug Administration, contractors of the 

9 Food and Drug Administration, advisory com10 mittees, and costs related to such officers and 

11 employees and to contracts with such contrac12 tors; 

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 subsection (a) 

22 and accounting for resources allocated for the 

23 review of abbreviated new drug applications and 

24 supplements and inspection related to generic 

25 drugs. 


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1 ‘‘(12) The term ‘Type II active pharmaceutical 

2 ingredient drug master file’ means a submission of 

3 information to the Secretary by a person that in4 tends to authorize the Food and Drug Administra5 tion to reference the information to support approval 

6 of a generic drug submission without the submitter 

7 having to disclose the information to the generic 

8 drug submission applicant. 

9 ‘‘SEC. 744B. AUTHORITY TO ASSESS AND USE HUMAN GE10 NERIC DRUG FEES. 

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

12 2013, the Secretary shall assess and collect fees in accord13 ance with this section as follows: 

14 ‘‘(1) ONE-TIME BACKLOG FEE FOR ABBRE15 VIATED NEW DRUG APPLICATIONS PENDING ON OC16 TOBER 1, 2012.— 

17 ‘‘(A) IN GENERAL.—Each person that 

18 owns an abbreviated new drug application that 

19 is pending on October 1, 2012, and that has 

20 not received a tentative approval prior to that 

21 date, shall be subject to a fee for each such ap22 plication, as calculated under subparagraph 

23 (B). 

24 ‘‘(B) METHOD OF FEE AMOUNT CALCULA25 TION.—The amount of each one-time backlog 


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1 fee shall be calculated by dividing $50,000,000 

2 by the total number of abbreviated new drug 

3 applications pending on October 1, 2012, that 

4 have not received a tentative approval as of that 

5 date. 

6 ‘‘(C) NOTICE.—Not later than October 31, 

7 2012, the Secretary shall cause to be published 

8 in the Federal Register a notice announcing the 

9 amount of the fee required by subparagraph 

10 (A). 

11 ‘‘(D) FEE DUE DATE.—The fee required 

12 by subparagraph (A) shall be due no later than 

13 30 calendar days after the date of the publica14 tion of the notice specified in subparagraph (C). 

15 ‘‘(2) DRUG MASTER FILE FEE.— 

16 ‘‘(A) IN GENERAL.—Each person that 

17 owns a Type II active pharmaceutical ingre18 dient drug master file that is referenced on or 

19 after October 1, 2012, in a generic drug sub20 mission by any initial letter of authorization 

21 shall be subject to a drug master file fee. 

22 ‘‘(B) ONE-TIME PAYMENT.—If a person 

23 has paid a drug master file fee for a Type II 

24 active pharmaceutical ingredient drug master 

25 file, the person shall not be required to pay a 


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1 subsequent drug master file fee when that Type 

2 II active pharmaceutical ingredient drug master 

3 file is subsequently referenced in generic drug 

4 submissions. 

5 ‘‘(C) NOTICE.— 

6 ‘‘(i) FISCAL YEAR 2013.—Not later 

7 than October 31, 2012, the Secretary shall 

8 cause to be published in the Federal Reg9 ister a notice announcing the amount of 

10 the drug master file fee for fiscal year 

11 2013. 

12 ‘‘(ii) FISCAL YEAR 2014 THROUGH

13 2017.—Not later than 60 days before the 

14 start of each of fiscal years 2014 through 

15 2017, the Secretary shall cause to be pub16 lished in the Federal Register the amount 

17 of the drug master file fee established by 

18 this paragraph for such fiscal year. 

19 ‘‘(D) AVAILABILITY FOR REFERENCE.— 

20 ‘‘(i) IN GENERAL.—Subject to sub21 section (g)(2)(C), for a generic drug sub22 mission to reference a Type II active phar23 maceutical ingredient drug master file, the 

24 drug master file must be deemed available 

25 for reference by the Secretary. 


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1 ‘‘(ii) CONDITIONS.—A drug master 

2 file shall be deemed available for reference 

3 by the Secretary if— 

4 ‘‘(I) the person that owns a Type 

5 II active pharmaceutical ingredient 

6 drug master file has paid the fee re7 quired under subparagraph (A) within 

8 20 calendar days after the applicable 

9 due date under subparagraph (E); 

10 and 

11 ‘‘(II) the drug master file has not 

12 failed an initial completeness assess13 ment by the Secretary, in accordance 

14 with criteria to be published by the 

15 Secretary. 

16 ‘‘(iii) LIST.—The Secretary shall 

17 make available on the public Internet Web 

18 site of the Food and Drug Administration 

19 a list of the drug master file numbers that 

20 correspond to drug master files that have 

21 successfully undergone an initial complete22 ness assessment, in accordance with cri23 teria to be published by the Secretary, and 

24 are available for reference. 

25 ‘‘(E) FEE DUE DATE.— 


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1 ‘‘(i) IN GENERAL.—Subject to clauses 

2 (ii), a drug master file fee shall be due no 

3 later than the date on which the first ge4 neric drug submission is submitted that 

5 references the associated Type II active 

6 pharmaceutical ingredient drug master file. 

7 ‘‘(ii) LIMITATION.—No fee shall be 

8 due under subparagraph (A) for a fiscal 

9 year until the later of— 

10 ‘‘(I) 30 calendar days after publi11 cation of the notice provided for in 

12 clause (i) or (ii) of subparagraph (C), 

13 as applicable; or 

14 ‘‘(II) 30 calendar days after the 

15 date of enactment of an appropria16 tions Act providing for the collection 

17 and obligation of fees under this sec18 tion 

19 ‘‘(3) ABBREVIATED NEW DRUG APPLICATION

20 AND PRIOR APPROVAL SUPPLEMENT FILING FEE.— 

21 ‘‘(A) IN GENERAL.—Each applicant that 

22 submits, on or after October 1, 2012, an abbre23 viated new drug application or a prior approval 

24 supplement to an abbreviated new drug applica25 tion shall be subject to a fee for each such subVerDate Mar 15 2010 04:33 Feb 09, 2012 Jkt 019200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\H3988.IH H3988

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1 mission in the amount established under sub2 section (d). 

3 ‘‘(B) NOTICE.— 

4 ‘‘(i) FISCAL YEAR 2013.—Not later 

5 than October 31, 2012, the Secretary shall 

6 cause to be published in the Federal Reg7 ister a notice announcing the amount of 

8 the fees under subparagraph (A) for fiscal 

9 year 2013. 

10 ‘‘(ii) FISCAL YEARS 2014 THROUGH

11 2017.—Not later than 60 days before the 

12 start of each of fiscal years 2014 through 

13 2017, the Secretary shall cause to be pub14 lished in the Federal Register the amount 

15 of the fees under subparagraph (A) for 

16 such fiscal year. 

17 ‘‘(C) FEE DUE DATE.— 

18 ‘‘(i) IN GENERAL.—Except as pro19 vided in clause (ii), the fees required by 

20 subparagraphs (A) and (F) shall be due no 

21 later than the date of submission of the 

22 abbreviated new drug application or prior 

23 approval supplement for which such fee ap24 plies. 


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1 ‘‘(ii) SPECIAL RULE FOR 2013.—For 

2 fiscal year 2013, such fees shall be due on 

3 the later of— 

4 ‘‘(I) the date on which the fee is 

5 due under clause (i); 

6 ‘‘(II) 30 calendar days after pub7 lication of the notice referred to in 

8 subparagraph (B)(i); or 

9 ‘‘(III) if an appropriations Act is 

10 not enacted providing for the collec11 tion and obligation of fees under this 

12 section by the date of submission of 

13 the application or prior approval sup14 plement for which the fees under sub15 paragraphs (A) and (F) apply, 30 cal16 endar days after the date that such an 

17 appropriations Act is enacted. 

18 ‘‘(D) REFUND OF FEE IF ABBREVIATED

19 NEW DRUG APPLICATION IS NOT CONSIDERED

20 TO HAVE BEEN RECEIVED.—The Secretary 

21 shall refund 75 percent of the fee paid under 

22 subparagraph (A) for any abbreviated new drug 

23 application or prior approval supplement to an 

24 abbreviated new drug application that the Sec25 retary considers not to have been received withVerDate Mar 15 2010 04:33 Feb 09, 2012 Jkt 019200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6201 E:\BILLS\H3988.IH H3988

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1 in the meaning of section 505(j)(5)(A) for a 

2 cause other than failure to pay fees. 

3 ‘‘(E) FEE FOR AN APPLICATION THE SEC4 RETARY CONSIDERS NOT TO HAVE BEEN RE5 CEIVED, OR THAT HAS BEEN WITHDRAWN.—An 

6 abbreviated new drug application or prior ap7 proval supplement that was submitted on or 

8 after October 1, 2012, and that the Secretary 

9 considers not to have been received, or that has 

10 been withdrawn, shall, upon resubmission of the 

11 application or a subsequent new submission fol12 lowing the applicant’s withdrawal of the appli13 cation, be subject to a full fee under subpara14 graph (A). 

15 ‘‘(F) ADDITIONAL FEE FOR ACTIVE PHAR16 MACEUTICAL INGREDIENT INFORMATION NOT

17 INCLUDED BY REFERENCE TO TYPE II ACTIVE

18 PHARMACEUTICAL INGREDIENT DRUG MASTER

19 FILE.—An applicant that submits a generic 

20 drug submission on or after October 1, 2012, 

21 shall pay a fee, in the amount determined under 

22 subsection (d)(3), in addition to the fee re23 quired under subparagraph (A), if— 

24 ‘‘(i) such submission contains infor25 mation concerning the manufacture of an 


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1 active pharmaceutical ingredient at a facil2 ity by means other than reference by a let3 ter of authorization to a Type II active 

4 pharmaceutical drug master file; and 

5 ‘‘(ii) a fee in the amount equal to the 

6 drug master file fee established in para7 graph (2) has not been previously paid 

8 with respect to such information. 

9 ‘‘(4) GENERIC DRUG FACILITY FEE AND ACTIVE

10 PHARMACEUTICAL INGREDIENT FACILITY FEE.— 

11 ‘‘(A) IN GENERAL.—Facilities identified, 

12 or intended to be identified, in at least one ge13 neric drug submission that is pending or ap14 proved to produce a finished dosage form of a 

15 human generic drug or an active pharma16 ceutical ingredient contained in a human ge17 neric drug shall be subject to fees as follows: 

18 ‘‘(i) GENERIC DRUG FACILITY.—Each 

19 person that owns a facility which is identi20 fied or intended to be identified in at least 

21 one generic drug submission that is pend22 ing or approved to produce one or more 

23 finished dosage forms of a human generic 

24 drug shall be assessed an annual fee for 

25 each such facility. 


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1 ‘‘(ii) ACTIVE PHARMACEUTICAL IN2 GREDIENT FACILITY.—Each person that 

3 owns a facility which produces, or which is 

4 pending review to produce, one or more ac5 tive pharmaceutical ingredients identified, 

6 or intended to be identified, in at least one 

7 generic drug submission that is pending or 

8 approved or in a Type II active pharma9 ceutical ingredient drug master file ref10 erenced in such a generic drug submission, 

11 shall be assessed an annual fee for each 

12 such facility. 

13 ‘‘(iii) FACILITIES PRODUCING BOTH

14 ACTIVE PHARMACEUTICAL INGREDIENTS

15 AND FINISHED DOSAGE FORMS.—Each 

16 person that owns a facility identified, or 

17 intended to be identified, in at least one 

18 generic drug submission that is pending or 

19 approved to produce both one or more fin20 ished dosage forms subject to clause (i) 

21 and one or more active pharmaceutical in22 gredients subject to clause (ii) shall be 

23 subject to fees under both such clauses for 

24 that facility. 


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1 ‘‘(B) AMOUNT.—The amount of fees estab2 lished under subparagraph (A) shall be estab3 lished under subsection (d). 

4 ‘‘(C) NOTICE.— 

5 ‘‘(i) FISCAL YEAR 2013.—For fiscal 

6 year 2013, the Secretary shall cause to be 

7 published in the Federal Register a notice 

8 announcing the amount of the fees pro9 vided for in subparagraph (A) within the 

10 timeframe specified in subsection 

11 (d)(1)(B). 

12 ‘‘(ii) FISCAL YEARS 2014 THROUGH

13 2017.—Within the timeframe specified in 

14 subsection (d)(2), the Secretary shall cause 

15 to be published in the Federal Register the 

16 amount of the fees under subparagraph 

17 (A) for such fiscal year. 

18 ‘‘(D) FEE DUE DATE.— 

19 ‘‘(i) FISCAL YEAR 2013.—For fiscal 

20 year 2013, the fees under subparagraph 

21 (A) shall be due on the later of— 

22 ‘‘(I) not later than 45 days after 

23 the publication of the notice under 

24 subparagraph (B); or 


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1 ‘‘(II) if an appropriations Act is 

2 not enacted providing for the collec3 tion and obligation of fees under this 

4 section by the date of the publication 

5 of such notice, 30 days after the date 

6 that such an appropriations Act is en7 acted. 

8 ‘‘(ii) FISCAL YEARS 2014 THROUGH

9 2017.—For each of fiscal years 2014 

10 through 2017, the fees under subpara11 graph (A) for such fiscal year shall be due 

12 on the later of— 

13 ‘‘(I) the first business day on or 

14 after October 1 of each such year; or 

15 ‘‘(II) the first business day after 

16 the enactment of an appropriations 

17 Act providing for the collection and 

18 obligation of fees under this section 

19 for such year. 

20 ‘‘(5) DATE OF SUBMISSION.—For purposes of 

21 this part, a generic drug submission or Type II 

22 pharmaceutical master file is deemed to be ‘sub23 mitted’ to the Food and Drug Administration when 

24 it arrives in the appropriate electronic portal of the 

25 Food and Drug Administration or, if in paper form, 


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1 at the appropriate designated document room of the 

2 Food and Drug Administration. 

3 ‘‘(b) FEE REVENUE AMOUNTS.— 

4 ‘‘(1) IN GENERAL.— 

5 ‘‘(A) FISCAL YEAR 2013.—For fiscal year 

6 2013, fees under subsection (a) shall be estab7 lished to generate a total estimated revenue 

8 amount under such subsection of $299,000,000. 

9 Of that amount— 

10 ‘‘(i) $50,000,000 shall be generated 

11 by the one-time backlog fee for generic 

12 drug applications pending on October 1, 

13 2012, established in subsection (a)(1); and 

14 ‘‘(ii) $249,000,000 shall be generated 

15 by the fees under paragraphs (2) through 

16 (4) of subsection (a). 

17 ‘‘(B) FISCAL YEARS 2014 THROUGH 2017.— 

18 For each of the fiscal years 2014 through 2017, 

19 fees under paragraphs (2) through (4) of sub20 section (a) shall be established to generate a 

21 total estimated revenue amount under such sub22 section that is equal to $299,000,000, as ad23 justed pursuant to subsection (c). 

24 ‘‘(2) TYPES OF FEES.—In establishing fees 

25 under paragraph (1) to generate the revenue 


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1 amounts specified in paragraph (1)(A)(ii) for fiscal 

2 year 2013 and (1)(B) for each of fiscal years 2014 

3 through 2017, such fees shall be derived from the 

4 fees under paragraphs (2) through (4) of subsection 

5 (a) as follows: 

6 ‘‘(A) 6 percent shall be derived from fees 

7 under subsection (a)(2) (relating to drug mas8 ter files). 

9 ‘‘(B) 24 percent shall be derived from fees 

10 under subsection (a)(3) (relating to abbreviated 

11 new drug applications and supplements). The 

12 amount of a fee for a prior approval supplement 

13 shall be half the amount of the fee for an ab14 breviated new drug application. 

15 ‘‘(C) 56 percent shall be derived from fees 

16 under subsection (a)(4)(A)(i) (relating to ge17 neric drug facilities). The amount of the fee for 

18 a facility located outside the United States and 

19 its territories and possessions shall be not less 

20 than $15,000 and not more than $30,000 high21 er than the amount of the fee for a facility lo22 cated in the United States and its territories 

23 and possessions, as determined by the Secretary 

24 on the basis of data concerning the difference 

25 in cost between inspections of facilities located 


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1 in the United States, including its territories 

2 and possessions, and those located outside of 

3 the United States and its territories and posses4 sions. 

5 ‘‘(D) 14 percent shall be derived from fees 

6 under subsection (a)(4)(A)(ii) (relating to active 

7 pharmaceutical ingredient facilities). The 

8 amount of the fee for a facility located outside 

9 the United States and its territories and posses10 sions shall be not less than $15,000 and not 

11 more than $30,000 higher than the amount of 

12 the fee for a facility located in the United 

13 States, including its territories and possessions, 

14 as determined by the Secretary on the basis of 

15 data concerning the difference in cost between 

16 inspections of facilities located in the United 

17 States and its territories and possessions and 

18 those located outside of the United States and 

19 its territories and possessions. 

20 ‘‘(c) ADJUSTMENTS.— 

21 ‘‘(1) INFLATION ADJUSTMENT.—For fiscal year 

22 2014 and subsequent fiscal years, the revenues es23 tablished in subsection (b) shall be adjusted by the 

24 Secretary by notice, published in the Federal RegVerDate Mar 15 2010 04:33 Feb 09, 2012 Jkt 019200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6201 E:\BILLS\H3988.IH H3988

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1 ister, for a fiscal year, by an amount equal to the 

2 sum of— 

3 ‘‘(A) one; 

4 ‘‘(B) the average annual change in the 

5 cost, per full-time equivalent position of the 

6 Food and Drug Administration, of all personnel 

7 compensation and benefits paid with respect to 

8 such positions for the first 3 years of the pre9 ceding 4 fiscal years multiplied by the propor10 tion of personnel compensation and benefits 

11 costs to total costs of human generic drug ac12 tivities for the first 3 years of the preceding 4 

13 fiscal years; and 

14 ‘‘(C) the average annual change that oc15 curred in the Consumer Price Index for urban 

16 consumers (Washington-Baltimore, DC–MD– 

17 VA–WV; Not Seasonally Adjusted; All items; 

18 Annual Index) for the first 3 years of the pre19 ceding 4 years of available data multiplied by 

20 the proportion of all costs other than personnel 

21 compensation and benefits costs to total costs 

22 of human generic drug activities for the first 3 

23 years of the preceding 4 fiscal years. 

24 The adjustment made each fiscal year under this 

25 subsection shall be added on a compounded basis to 


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1 the sum of all adjustments made each fiscal year 

2 after fiscal year 2013 under this subsection. 

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

4 year 2017, the Secretary may, in addition to adjust5 ments under paragraph (1), further increase the fee 

6 revenues and fees established in subsection (b) if 

7 such an adjustment is necessary to provide for not 

8 more than 3 months of operating reserves of carry9 over user fees for human generic drug activities for 

10 the first 3 months of fiscal year 2018. Such fees 

11 may only be used in fiscal year 2018. If such an ad12 justment is necessary, the rationale for the amount 

13 of the increase shall be contained in the annual no14 tice establishing fee revenues and fees for fiscal year 

15 2017. If the Secretary has carryover balances for 

16 such activities in excess of 3 months of such oper17 ating reserves, the adjustment under this subpara18 graph shall not be made. 

19 ‘‘(d) ANNUAL FEE SETTING.— 

20 ‘‘(1) FISCAL YEAR 2013.—For fiscal year 

21 2013— 

22 ‘‘(A) the Secretary shall establish, by Octo23 ber 31, 2012, the one-time generic drug backlog 

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1 breviated new drug application fee, and the 

2 prior approval supplement fee under subsection 

3 (a), based on the revenue amounts established 

4 under subsection (b); and 

5 ‘‘(B) the Secretary shall establish, not 

6 later than 45 days after the date to comply 

7 with the requirement for identification of facili8 ties in subsection (f)(2), the generic drug facil9 ity fee and active pharmaceutical ingredient fa10 cility fee under subsection (a) based on the rev11 enue amounts established under subsection (b). 

12 ‘‘(2) FISCAL YEARS 2014 THROUGH 2017.—Not 

13 more than 60 days before the first day of each of 

14 fiscal years 2014 through 2017, the Secretary shall 

15 establish the drug master file fee, the abbreviated 

16 new drug application fee, the prior approval supple17 ment fee, the generic drug facility fee, and the active 

18 pharmaceutical ingredient facility fee under sub19 section (a) for such fiscal year, based on the revenue 

20 amounts established under subsection (b) and the 

21 adjustments provided under subsection (c). 

22 ‘‘(3) FEE FOR ACTIVE PHARMACEUTICAL IN23 GREDIENT INFORMATION NOT INCLUDED BY REF24 ERENCE TO TYPE II ACTIVE PHARMACEUTICAL IN25 GREDIENT DRUG MASTER FILE.—In establishing the 


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1 fees under paragraphs (1) and (2), the amount of 

2 the fee under subsection (a)(3)(F) shall be deter3 mined by multiplying— 

4 ‘‘(A) the sum of— 

5 ‘‘(i) the total number of such active 

6 pharmaceutical ingredients in such submis7 sion; and 

8 ‘‘(ii) for each such ingredient that is 

9 manufactured at more than one such facil10 ity, the total number of such additional fa11 cilities; and 

12 ‘‘(B) the amount equal to the drug master 

13 file fee established in subsection (a)(2) for such 

14 submission. 

15 ‘‘(e) LIMIT.—The total amount of fees charged, as 

16 adjusted under subsection (c), for a fiscal year may not 

17 exceed the total costs for such fiscal year for the resources 

18 allocated for human generic drug activities. 

19 ‘‘(f) IDENTIFICATION OF FACILITIES.— 

20 ‘‘(1) PUBLICATION OF NOTICE; DEADLINE FOR

21 COMPLIANCE.—Not later than October 1, 2012, the 

22 Secretary shall cause to be published in the Federal 

23 Register a notice requiring each person that owns a 

24 facility described in subsection (a)(4)(A), or a site or 

25 organization required to be identified by paragraph 


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1 (4), to submit to the Secretary information on the 

2 identity of each such facility, site, or organization. 

3 The notice required by this paragraph shall specify 

4 the type of information to be submitted and the 

5 means and format for submission of such informa6 tion. 

7 ‘‘(2) REQUIRED SUBMISSION OF FACILITY

8 IDENTIFICATION.—Each person that owns a facility 

9 described in subsection (a)(4)(A) or a site or organi10 zation required to be identified by paragraph (4) 

11 shall submit to the Secretary the information re12 quired under this subsection each year. Such infor13 mation shall— 

14 ‘‘(A) for fiscal year 2013, be submitted not 

15 later than 60 days after the publication of the 

16 notice under paragraph (1); and 

17 ‘‘(B) for each subsequent fiscal year, be 

18 submitted, updated, or reconfirmed on or before 

19 June 1 of such year. 

20 ‘‘(3) CONTENTS OF NOTICE.—At a minimum, 

21 the submission required by paragraph (2) shall in22 clude for each such facility— 

23 ‘‘(A) identification of a facility identified or 

24 intended to be identified in an approved or 

25 pending generic drug submission; 


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1 ‘‘(B) whether the facility manufactures ac2 tive pharmaceutical ingredients or finished dos3 age forms, or both; 

4 ‘‘(C) whether or not the facility is located 

5 within the United States and its territories and 

6 possessions; 

7 ‘‘(D) whether the facility manufactures 

8 positron emission tomography drugs solely, or 

9 in addition to other drugs; and 

10 ‘‘(E) whether the facility manufactures 

11 drugs that are not generic drugs. 

12 ‘‘(4) CERTAIN SITES AND ORGANIZATIONS.— 

13 ‘‘(A) IN GENERAL.—Any person that owns 

14 or operates a site or organization described in 

15 subparagraph (B) shall submit to the Secretary 

16 information concerning the ownership, name, 

17 and address of the site or organization. 

18 ‘‘(B) SITES AND ORGANIZATIONS.—A site 

19 or organization is described in this subpara20 graph if it is identified in a generic drug sub21 mission and is— 

22 ‘‘(i) a site in which a bioanalytical 

23 study is conducted; 

24 ‘‘(ii) a clinical research organization; 


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1 ‘‘(iii) a contract analytical testing site; 

2 or 

3 ‘‘(iv) a contract repackager site. 

4 ‘‘(C) NOTICE.—The Secretary may, by no5 tice published in the Federal Register, specify 

6 the means and format for submission of the in7 formation under subparagraph (A) and may 

8 specify, as necessary for purposes of this sec9 tion, any additional information to be sub10 mitted. 

11 ‘‘(D) INSPECTION AUTHORITY.—The Sec12 retary’s inspectional authority under section 

13 704(a)(1) shall extend to all such sites and or14 ganizations. 

15 ‘‘(g) EFFECT OF FAILURE TO PAY FEES.— 

16 ‘‘(1) GENERIC DRUG BACKLOG FEE.—Failure 

17 to pay the fee under subsection (a)(1) shall result in 

18 the Secretary placing the person that owns the ab19 breviated new drug application subject to that fee on 

20 an arrears list, such that no new abbreviated new 

21 drug applications or supplement submitted on or 

22 after October 1, 2012, from that person, or any af23 filiate of that person, will be received within the 

24 meaning of section 505(j)(5)(A) until such out25 standing fee is paid. 


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1 ‘‘(2) DRUG MASTER FILE FEE.— 

2 ‘‘(A) Failure to pay the fee under sub3 section (a)(2) within 20 calendar days after the 

4 applicable due date under subparagraph (E) of 

5 such subsection (as described in subsection 

6 (a)(2)(D)(ii)(I)) shall result in the Type II ac7 tive pharmaceutical ingredient drug master file 

8 not being deemed available for reference. 

9 ‘‘(B)(i) Any generic drug submission sub10 mitted on or after October 1, 2012, that ref11 erences, by a letter of authorization, a Type II 

12 active pharmaceutical ingredient drug master 

13 file that has not been deemed available for ref14 erence shall not be received within the meaning 

15 of section 505(j)(5)(A) unless the condition 

16 specified in clause (ii) is met. 

17 ‘‘(ii) The condition specified in this clause 

18 is that the fee established under subsection 

19 (a)(2) has been paid within 20 calendar days of 

20 the Secretary providing the notification to the 

21 sponsor of the abbreviated new drug application 

22 or supplement of the failure of the owner of the 

23 Type II active pharmaceutical ingredient drug 

24 master file to pay the drug master file fee as 

25 specified in subparagraph (C). 


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1 ‘‘(C)(i) If an abbreviated new drug applica2 tion or supplement to an abbreviated new drug 

3 application references a Type II active pharma4 ceutical ingredient drug master file for which a 

5 fee under subsection (a)(2)(A) has not been 

6 paid by the applicable date under subsection 

7 (a)(2)(E), the Secretary shall notify the sponsor 

8 of the abbreviated new drug application or sup9 plement of the failure of the owner of the Type 

10 II active pharmaceutical ingredient drug master 

11 file to pay the applicable fee. 

12 ‘‘(ii) If such fee is not paid within 20 cal13 endar days of the Secretary providing the noti14 fication, the abbreviated new drug application 

15 or supplement to an abbreviated new drug ap16 plication shall not be received within the mean17 ing of 505(j)(5)(A). 

18 ‘‘(3) ABBREVIATED NEW DRUG APPLICATION

19 FEE AND PRIOR APPROVAL SUPPLEMENT FEE.— 

20 Failure to pay a fee under subparagraph (A) or (F) 

21 of subsection (a)(3) within 20 calendar days of the 

22 applicable due date under subparagraph (C) of such 

23 subsection shall result in the abbreviated new drug 

24 application or the prior approval supplement to an 

25 abbreviated new drug application not being received 


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1 within the meaning of section 505(j)(5)(A) until 

2 such outstanding fee is paid. 

3 ‘‘(4) GENERIC DRUG FACILITY FEE AND ACTIVE

4 PHARMACEUTICAL INGREDIENT FACILITY FEE.— 

5 ‘‘(A) IN GENERAL.—Failure to pay the fee 

6 under subsection (a)(4) within 20 calendar days 

7 of the due date as specified in subparagraph 

8 (D) of such subsection shall result in the fol9 lowing: 

10 ‘‘(i) The Secretary shall place the fa11 cility on a publicly available arrears list, 

12 such that no new abbreviated new drug ap13 plication or supplement submitted on or 

14 after October 1, 2012, from the person 

15 that is responsible for paying such fee, or 

16 any affiliate of that person, will be received 

17 within the meaning of section 505(j)(5)(A). 

18 ‘‘(ii) Any new generic drug submission 

19 submitted on or after October 1, 2012, 

20 that references such a facility shall not be 

21 received, within the meaning of 

22 505(j)(5)(A) if the outstanding facility fee 

23 is not paid within 20 calendar days of the 

24 Secretary providing the notification to the 

25 sponsor of the failure of the owner of the 


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1 facility to pay the facility fee under sub2 section (a)(4)(C). 

3 ‘‘(iii) All drugs or active pharma4 ceutical ingredients manufactured in such 

5 a facility or containing an ingredient man6 ufactured in such a facility shall be deemed 

7 misbranded under section 502(aa). 

8 ‘‘(B) APPLICATION OF PENALTIES.—The 

9 penalties under this paragraph shall apply until 

10 the fee established by subsection (a)(4) is paid 

11 or the facility is removed from all generic drug 

12 submissions that refer to the facility. 

13 ‘‘(C) NONRECEIVAL FOR NONPAYMENT.— 

14 ‘‘(i) NOTICE.—If an abbreviated new 

15 drug application or supplement to an ab16 breviated new drug application submitted 

17 on or after October 1, 2012, references a 

18 facility for which a facility fee has not been 

19 paid by the applicable date under sub20 section (a)(4)(C), the Secretary shall notify 

21 the sponsor of the generic drug submission 

22 of the failure of the owner of the facility 

23 to pay the facility fee. 

24 ‘‘(ii) NONRECEIVAL.—If the facility 

25 fee is not paid within 20 calendar days of 


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1 the Secretary providing the notification 

2 under clause (i), the abbreviated new drug 

3 application or supplement to an abbre4 viated new drug application shall not be re5 ceived within the meaning of 505(j)(5)(A). 

6 ‘‘(h) LIMITATIONS.— 

7 ‘‘(1) IN GENERAL.—Fees under subsection (a) 

8 shall be refunded for a fiscal year beginning after 

9 fiscal year 2012, unless appropriations for salaries 

10 and expenses of the Food and Drug Administration 

11 for such fiscal year (excluding the amount of fees 

12 appropriated for such fiscal year) are equal to or 

13 greater than the amount of appropriations for the 

14 salaries and expenses of the Food and Drug Admin15 istration for the fiscal year 2009 (excluding the 

16 amount of fees appropriated for such fiscal year) 

17 multiplied by the adjustment factor (as defined in 

18 section 744A) applicable to the fiscal year involved. 

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

20 assess fees under subsection (a) during any portion 

21 of a fiscal year and if at a later date in such fiscal 

22 year the Secretary may assess such fees, the Sec23 retary may assess and collect such fees, without any 

24 modification in the rate, for Type II active pharma25 ceutical ingredient drug master files, abbreviated 


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1 new drug applications and prior approval supple2 ments, and generic drug facilities and active phar3 maceutical ingredient facilities at any time in such 

4 fiscal year notwithstanding the provisions of sub5 section (a) relating to the date fees are to be paid. 

6 ‘‘(i) CREDITING AND AVAILABILITY OF FEES.— 

7 ‘‘(1) IN GENERAL.—Fees authorized under sub8 section (a) shall be collected and available for obliga9 tion only to the extent and in the amount provided 

10 in advance in appropriations Acts, subject to para11 graph (2). Such fees are authorized to remain avail12 able until expended. Such sums as may be necessary 

13 may be transferred from the Food and Drug Admin14 istration salaries and expenses appropriation account 

15 without fiscal year limitation to such appropriation 

16 account for salaries and expenses with such fiscal 

17 year limitation. The sums transferred shall be avail18 able solely for human generic drug activities. 

19 ‘‘(2) COLLECTIONS AND APPROPRIATION

20 ACTS.— 

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

22 by this section— 

23 ‘‘(i) subject to subparagraphs (C) and 

24 (D), shall be collected and available in each 

25 fiscal year in an amount not to exceed the 


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1 amount specified in appropriation Acts, or 

2 otherwise made available for obligation for 

3 such fiscal year; and 

4 ‘‘(ii) shall be available for a fiscal year 

5 beginning after fiscal year 2012 to defray 

6 the costs of human generic drug activities 

7 (including such costs for an additional 

8 number of full-time equivalent positions in 

9 the Department of Health and Human 

10 Services to be engaged in such activities), 

11 only if the Secretary allocates for such 

12 purpose an amount for such fiscal year 

13 (excluding amounts from fees collected 

14 under this section) no less than 

15 $97,000,000 multiplied by the adjustment 

16 factor defined in subsection (p)(3) applica17 ble to the fiscal year involved. 

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

19 be considered to have met the requirements of 

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

21 costs funded by appropriations and allocated for 

22 human generic activities are not more than 10 

23 percent below the level specified in such sub24 paragraph. 


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1 ‘‘(C) FEE COLLECTION DURING FIRST

2 PROGRAM YEAR.—Until the date of enactment 

3 of an Act making appropriations through Sep4 tember 30, 2013 for the salaries and expenses 

5 account of the Food and Drug Administration, 

6 fees authorized by this section for fiscal year 

7 2013, may be collected and shall be credited to 

8 such account and remain available until ex9 pended. 

10 ‘‘(D) PROVISION FOR EARLY PAYMENTS IN

11 SUBSEQUENT YEARS.—Payment of fees author12 ized under this section for a fiscal year (after 

13 fiscal year 2013), prior to the due date for such 

14 fees, may be accepted by the Secretary in ac15 cordance with authority provided in advance in 

16 a prior year appropriations Act. 

17 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

18 For each of the fiscal years 2013 through 2017, 

19 there is authorized to be appropriated for fees under 

20 this section an amount equivalent to the total rev21 enue amount determined under subsection (b) for 

22 the fiscal year, as adjusted under subsection (c), if 

23 applicable, or as otherwise affected under paragraph 

24 (2) of this subsection. 


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1 ‘‘(j) COLLECTION OF UNPAID FEES.—In any case 

2 where the Secretary does not receive payment of a fee as3 sessed under subsection (a) within 30 calendar days after 

4 it is due, such fee shall be treated as a claim of the United 

5 States Government subject to subchapter II of chapter 37 

6 of title 31, United States Code. 

7 ‘‘(k) CONSTRUCTION.—This section may not be con8 strued to require that the number of full-time equivalent 

9 positions in the Department of Health and Human Serv10 ices, for officers, employees, and advisory committees not 

11 engaged in human generic drug activities, be reduced to 

12 offset the number of officers, employees, and advisory 

13 committees so engaged. 

14 ‘‘(l) POSITRON EMISSION TOMOGRAPHY DRUGS.— 

15 ‘‘(1) EXEMPTION FROM FEES.—Submission of 

16 an application for a positron emission tomography 

17 drug or active pharmaceutical ingredient for a 

18 positron emission tomography drug shall not require 

19 the payment of any fee under this section. Facilities 

20 that solely produce positron emission tomography 

21 drugs shall not be required to pay a facility fee as 

22 established in subsection (a)(4). 

23 ‘‘(2) IDENTIFICATION REQUIREMENT.—Facili24 ties that produce positron emission tomography 

25 drugs or active pharmaceutical ingredients of such 


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1 drugs are required to be identified pursuant to sub2 section (f). 

3 ‘‘(m) DISPUTES CONCERNING FEES.—To qualify for 

4 the return of a fee claimed to have been paid in error 

5 under this section, a person shall submit to the Secretary 

6 a written request justifying such return within 180 cal7 endar days after such fee was paid. 

8 ‘‘(n) SUBSTANTIALLY COMPLETE APPLICATIONS.— 

9 An abbreviated new drug application that is not consid10 ered to be received within the meaning of section 

11 505(j)(5)(A) because of failure to pay an applicable fee 

12 under this provision within the time period specified in 

13 subsection (g) shall be deemed not to have been ‘substan14 tially complete’ on the date of its submission within the 

15 meaning of section 505(j)(5)(B)(iv)(II)(cc). An abbre16 viated new drug application that is not substantially com17 plete on the date of its submission solely because of failure 

18 to pay an applicable fee under the preceding sentence shall 

19 be deemed substantially complete and received within the 

20 meaning of section 505(j)(5)(A) as of the date such appli21 cable fee is received.’’. 

22 SEC. 103. REAUTHORIZATION; REPORTING REQUIREMENTS. 

23 Part 7 of subchapter C of chapter VII, as added by 

24 section 102 of this Act, is amended by inserting after sec25 tion 744B the following: 


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1 ‘‘SEC. 744C. REAUTHORIZATION; REPORTING REQUIRE2 MENTS. 

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

4 year 2013, not later than 120 days after the end of each 

5 fiscal year for which fees are collected under this part, 

6 the Secretary shall prepare and submit to the Committee 

7 on Energy and Commerce of the House of Representatives 

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

9 Pensions of the Senate a report concerning the progress 

10 of the Food and Drug Administration in achieving the 

11 goals identified in the letters described in section 101(c) 

12 of the Generic Drug User Fee Amendments of 2012 dur13 ing such fiscal year and the future plans of the Food and 

14 Drug Administration for meeting the goals. 

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

16 2013, not later than 120 days after the end of each fiscal 

17 year for which fees are collected under this part, the Sec18 retary shall prepare and submit to the Committee on En19 ergy and Commerce of the House of Representatives and 

20 the Committee on Health, Education, Labor, and Pen21 sions of the Senate a report on the implementation of the 

22 authority for such fees during such fiscal year and the 

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

24 collected for such fiscal year. 

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

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


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

2 Food and Drug Administration. 

3 ‘‘(d) REAUTHORIZATION.— 

4 ‘‘(1) CONSULTATION.—In developing rec5 ommendations to present to the Congress with re6 spect to the goals, and plans for meeting the goals, 

7 for human generic drug activities for the first 5 fis8 cal years after fiscal year 2017, and for the reau9 thorization of this part for such fiscal years, the Sec10 retary shall consult with— 

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

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

14 Labor, and Pensions of the Senate; 

15 ‘‘(C) scientific and academic experts; 

16 ‘‘(D) health care professionals; 

17 ‘‘(E) representatives of patient and con18 sumer advocacy groups; and 

19 ‘‘(F) the generic drug industry. 

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

21 negotiations with the generic drug industry on the 

22 reauthorization of this part, the Secretary shall— 

23 ‘‘(A) publish a notice in the Federal Reg24 ister requesting public input on the reauthoriza25 tion; 


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

2 public may present its views on the reauthoriza3 tion, including specific suggestions for changes 

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

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

6 public meeting to obtain written comments from 

7 the public suggesting changes to this part; and 

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

9 and Drug Administration’s Internet Web site. 

10 ‘‘(3) PERIODIC CONSULTATION.—Not less fre11 quently than once every month during negotiations 

12 with the generic drug industry, the Secretary shall 

13 hold discussions with representatives of patient and 

14 consumer advocacy groups to continue discussions of 

15 their views on the reauthorization and their sugges16 tions for changes to this part as expressed under 

17 paragraph (2). 

18 ‘‘(4) PUBLIC REVIEW OF RECOMMENDA19 TIONS.—After negotiations with the generic drug in20 dustry, the Secretary shall— 

21 ‘‘(A) present the recommendations devel22 oped under paragraph (1) to the Congressional 

23 committees specified in such paragraph; 

24 ‘‘(B) publish such recommendations in the 

25 Federal Register; 


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

2 the public to provide written comments on such 

3 recommendations; 

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

5 may present its views on such recommenda6 tions; and 

7 ‘‘(E) after consideration of such public 

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

10 ‘‘(5) TRANSMITTAL OF RECOMMENDATIONS.— 

11 Not later than January 15, 2017, the Secretary 

12 shall transmit to the Congress the revised rec13 ommendations under paragraph (4), a summary of 

14 the views and comments received under such para15 graph, and any changes made to the recommenda16 tions in response to such views and comments. 

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

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

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

21 Secretary shall make publicly available, on the 

22 public Web site of the Food and Drug Adminis23 tration, minutes of all negotiation meetings con24 ducted under this subsection between the Food 


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1 and Drug Administration and the generic drug 

2 industry. 

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

4 under subparagraph (A) shall summarize any 

5 substantive proposal made by any party to the 

6 negotiations as well as significant controversies 

7 or differences of opinion during the negotiations 

8 and their resolution.’’. 

9 SEC. 104. SUNSET DATES. 

10 (a) AUTHORIZATION.—The amendments made by 

11 section 102 cease to be effective October 1, 2017. 

12 (b) REPORTING REQUIREMENTS.—The amendments 

13 made by section 103 cease to be effective January 31, 

14 2018. 

15 SEC. 105. EFFECTIVE DATE. 

16 The amendments made by this title shall take effect 

17 on October 1, 2012, or the date of the enactment of this 

18 title, whichever is later, except that fees under section 102 

19 shall be assessed for all human generic drug submissions 

20 and Type II active pharmaceutical drug master files re21 ceived on or after October 1, 2012, regardless of the date 

22 of enactment of this title. 


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1 SEC. 106. AMENDMENT WITH RESPECT TO MISBRANDING. 

2 Section 502 of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 352) is amended by adding at the end the 

4 following: 

5 ‘‘(aa) If it is a drug, or an active pharmaceutical in6 gredient, and it was manufactured, prepared, propagated, 

7 compounded, or processed in a facility for which fees have 

8 not been paid as required by section 744A(a)(4) or for 

9 which identifying information required by section 744B(f) 

10 has not been submitted, or it contains an active pharma11 ceutical ingredient that was manufactured, prepared, 

12 propagated, compounded, or processed in such a facility.’’. 

13 SEC. 107. ELECTRONIC SUBMISSION OF APPLICATIONS. 

14 The Federal Food, Drug, and Cosmetic Act is amend15 ed by inserting after section 745 the following: 

16 ‘‘SEC. 745A. ELECTRONIC SUBMISSION OF APPLICATIONS:. 

17 ‘‘(a) IN GENERAL.—Beginning no earlier than 24 

18 months after the issuance of a final guidance issued after 

19 public notice and opportunity for comment, submissions 

20 under section 505(j) shall be submitted in such electronic 

21 format as specified by the Secretary in such guidance. 

22 ‘‘(b) GUIDANCE CONTENTS.—In such guidance, the 

23 Secretary may provide a timetable for establishment by 

24 the Secretary of further standards for such electronic sub25 mission, and set forth criteria for waivers of and exemp26 tions from the requirements of this section. 


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1 ‘‘(c) EXCEPTION.—This section shall not apply to 

2 submissions described in section 561.’’. 

3 SEC. 108. STREAMLINED HIRING AUTHORITY OF THE FOOD 

4 AND DRUG ADMINISTRATION TO SUPPORT 

5 ACTIVITIES RELATED TO HUMAN GENERIC 

6 DRUGS. 

7 Subchapter A of chapter VII of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amend9 ed by inserting after section 713 the following new section: 

10 ‘‘SEC. 714. STREAMLINED HIRING AUTHORITY. 

11 ‘‘(a) IN GENERAL.—In addition to any other per12 sonnel authorities under other provisions of law, the Sec13 retary may, without regard to the provisions of title 5, 

14 United States Code, governing appointments in the com15 petitive service, appoint employees to positions in the Food 

16 and Drug Administration to perform, administer, or sup17 port activities described in subsection (b), if the Secretary 

18 determines that such appointments are needed to achieve 

19 the objectives specified in subsection (c). 

20 ‘‘(b) ACTIVITIES DESCRIBED.—The activities de21 scribed in this subsection are activities under this Act re22 lated to human generic drug activities (as defined in sec23 tion 744A). 

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1 spect to section 744A (regarding assessment and use of 

2 human generic drug fees), as set forth in the letters de3 scribed in section 101(c) of the Generic Drug User Fee 

4 Amendments of 2012. 

5 ‘‘(d) INTERNAL CONTROLS.—The Secretary shall in6 stitute appropriate internal controls for appointments 

7 under this section. 

8 ‘‘(e) SUNSET.—The authority to appoint employees 

9 under this section shall terminate on the date that is three 

10 years after the date of enactment of this section.’’. 

11 TITLE II—FEES RELATING TO 

12 BIOSIMILAR BIOLOGICAL 

13 PRODUCTS 

14 SEC. 201. SHORT TITLE; REFERENCES IN TITLE; FINDING. 

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

16 ‘‘Biosimilar User Fee Act of 2012’’. 

17 (b) REFERENCES IN ACT.—Except as otherwise spec18 ified, amendments made by this title to a section or other 

19 provision of law are amendments to such section or other 

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

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

22 (c) FINDING.—The Congress finds that the fees au23 thorized by the amendments made in this title will be dedi24 cated to expediting the process for the review of biosimilar 

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1 ty activities, as set forth in the goals identified for pur2 poses of part 8 of subchapter C of chapter VII of the Fed3 eral Food, Drug, and Cosmetic Act, in the letters from 

4 the Secretary of Health and Human Services to the Chair5 man of the Committee on Health, Education, Labor, and 

6 Pensions of the Senate and the Chairman of the Com7 mittee on Energy and Commerce of the House of Rep8 resentatives, as set forth in the Congressional Record. 

9 SEC. 202. FEES RELATING TO BIOSIMILAR BIOLOGICAL 

10 PRODUCTS. 

11 Subchapter C of chapter VII (21 U.S.C. 379f et seq.) 

12 is amended by inserting after part 7, as added by title 

13 I of this Act, the following: 

14 ‘‘PART 8—FEES RELATING TO BIOSIMILAR 

15 BIOLOGICAL PRODUCTS 

16 ‘‘SEC. 744G. DEFINITIONS. 

17 ‘‘For purposes of this part: 

18 ‘‘(1) The term ‘adjustment factor’ applicable to 

19 a fiscal year that is the Consumer Price Index for 

20 all urban consumers (Washington-Baltimore, DC– 

21 MD–VA–WV; Not Seasonally Adjusted; All items) of 

22 the preceding fiscal year divided by such Index for 

23 September 2011. 


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1 ‘‘(2) The term ‘affiliate’ means a business enti2 ty that has a relationship with a second business en3 tity if, directly or indirectly— 

4 ‘‘(A) one business entity controls, or has 

5 the power to control, the other business entity; 

6 or 

7 ‘‘(B) a third party controls, or has power 

8 to control, both of the business entities. 

9 ‘‘(3) The term ‘biosimilar biological product’ 

10 means a product for which a biosimilar biological 

11 product application has been approved. 

12 ‘‘(4)(A) Subject to subparagraph (B), the term 

13 ‘biosimilar biological product application’ means an 

14 application for licensure of a biological product 

15 under section 351(k) of the Public Health Service 

16 Act. 

17 ‘‘(B) Such term does not include— 

18 ‘‘(i) a supplement to such an application; 

19 ‘‘(ii) an application filed under section 

20 351(k) of the Public Health Service Act that 

21 cites as the reference product a bovine blood 

22 product for topical application licensed before 

23 September 1, 1992, or a large volume paren24 teral drug product approved before such date; 


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1 ‘‘(iii) an application filed under section 

2 351(k) of the Public Health Service Act with 

3 respect to— 

4 ‘‘(I) whole blood or a blood component 

5 for transfusion; 

6 ‘‘(II) an allergenic extract product; 

7 ‘‘(III) an in vitro diagnostic biological 

8 product; or 

9 ‘‘(IV) a biological product for further 

10 manufacturing use only; or 

11 ‘‘(iv) an application for licensure under 

12 section 351(k) of the Public Health Service Act 

13 that is submitted by a State or Federal Govern14 ment entity for a product that is not distributed 

15 commercially. 

16 ‘‘(5) The term ‘biosimilar biological product de17 velopment meeting’ means any meeting, other than 

18 a biosimilar initial advisory meeting, regarding the 

19 content of a development program, including a pro20 posed design for, or data from, a study intended to 

21 support a biosimilar biological product application. 

22 ‘‘(6) The term ‘biosimilar biological product de23 velopment program’ means the program under this 

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1 missions in connection with biosimilar biological 

2 product development. 

3 ‘‘(7)(A) The term ‘biosimilar biological product 

4 establishment’ means a foreign or domestic place of 

5 business— 

6 ‘‘(i) that is at one general physical location 

7 consisting of one or more buildings, all of which 

8 are within five miles of each other; and 

9 ‘‘(ii) at which one or more biosimilar bio10 logical products are manufactured in final dos11 age form. 

12 ‘‘(B) For purposes of subparagraph (A)(ii), the 

13 term ‘manufactured’ does not include packaging. 

14 ‘‘(8) The term ‘biosimilar initial advisory meet15 ing’— 

16 ‘‘(A) means a meeting, if requested, that is 

17 limited to— 

18 ‘‘(i) a general discussion regarding 

19 whether licensure under section 351(k) of 

20 the Public Health Service Act may be fea21 sible for a particular product; and 

22 ‘‘(ii) if so, general advice on the ex23 pected content of the development pro24 gram; and 


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1 ‘‘(B) does not include any meeting that in2 volves substantive review of summary data or 

3 full study reports. 

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

5 the process for the review of biosimilar biological 

6 product applications’ means the expenses in connec7 tion with the process for the review of biosimilar bio8 logical product applications for— 

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

10 and Drug Administration, contractors of the 

11 Food and Drug Administration, advisory com12 mittees, and costs related to such officers em13 ployees and committees and to contracts with 

14 such contractors; 

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

16 acquisition, maintenance, and repair of com17 puter resources; 

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

19 repair of facilities and acquisition, maintenance, 

20 and repair of fixtures, furniture, scientific 

21 equipment, and other necessary materials and 

22 supplies; and 

23 ‘‘(D) collecting fees under section 744H 

24 and accounting for resources allocated for the 

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1 similar biological product development, bio2 similar biological product applications, and sup3 plements. 

4 ‘‘(10) The term ‘final dosage form’ means, with 

5 respect to a biosimilar biological product, a finished 

6 dosage form which is approved for administration to 

7 a patient without substantial further manufacturing 

8 (such as lyophilized products before reconstitution). 

9 ‘‘(11) The term ‘financial hold’— 

10 ‘‘(A) means an order issued by the Sec11 retary to prohibit the sponsor of a clinical in12 vestigation from continuing the investigation if 

13 the Secretary determines that the investigation 

14 is intended to support a biosimilar biological 

15 product application and the sponsor has failed 

16 to pay any fee for the product required under 

17 subparagraph (A), (B), or (D) of section 

18 744H(a)(1); and 

19 ‘‘(B) does not mean that any of the bases 

20 for a ‘clinical hold’ under section 505(i)(3) have 

21 been determined by the Secretary to exist con22 cerning the investigation. 

23 ‘‘(12) The term ‘person’ includes an affiliate of 

24 such person. 


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1 ‘‘(13) The term ‘process for the review of bio2 similar biological product applications’ means the 

3 following activities of the Secretary with respect to 

4 the review of submissions in connection with bio5 similar biological product development, biosimilar bi6 ological product applications, and supplements: 

7 ‘‘(A) The activities necessary for the re8 view of submissions in connection with bio9 similar biological product development, bio10 similar biological product applications, and sup11 plements. 

12 ‘‘(B) Actions related to submissions in con13 nection with biosimilar biological product devel14 opment, the issuance of action letters which ap15 prove biosimilar biological product applications 

16 or which set forth in detail the specific defi17 ciencies in such applications, and where appro18 priate, the actions necessary to place such ap19 plications in condition for approval. 

20 ‘‘(C) The inspection of biosimilar biological 

21 product establishments and other facilities un22 dertaken as part of the Secretary’s review of 

23 pending biosimilar biological product applica24 tions and supplements. 


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1 ‘‘(D) Activities necessary for the release of 

2 lots of biosimilar biological products under sec3 tion 351(k) of the Public Health Service Act. 

4 ‘‘(E) Monitoring of research conducted in 

5 connection with the review of biosimilar biologi6 cal product applications. 

7 ‘‘(F) Postmarket safety activities with re8 spect to biologics approved under biosimilar bio9 logical product applications or supplements, in10 cluding the following activities: 

11 ‘‘(i) Collecting, developing, and re12 viewing safety information on biosimilar bi13 ological products, including adverse event 

14 reports. 

15 ‘‘(ii) Developing and using improved 

16 adverse-event data-collection systems, in17 cluding information technology systems. 

18 ‘‘(iii) Developing and using improved 

19 analytical tools to assess potential safety 

20 problems, including access to external data 

21 bases. 

22 ‘‘(iv) Implementing and enforcing sec23 tion 505(o) (relating to postapproval stud24 ies and clinical trials and labeling changes) 


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1 and section 505(p) (relating to risk evalua2 tion and mitigation strategies). 

3 ‘‘(v) Carrying out section 505(k)(5) 

4 (relating to adverse event reports and 

5 postmarket safety activities). 

6 ‘‘(14) The term ‘supplement’ means a request 

7 to the Secretary to approve a change in a biosimilar 

8 biological product application which has been ap9 proved, including a supplement requesting that the 

10 Secretary determine that the biosimilar biological 

11 product meets the standards for interchangeability 

12 described in section 351(k)(4) of the Public Health 

13 Service Act. 

14 ‘‘SEC. 744H. AUTHORITY TO ASSESS AND USE BIOSIMILAR 

15 BIOLOGICAL PRODUCT FEES. 

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

17 2013, the Secretary shall assess and collect fees in accord18 ance with this section as follows: 

19 ‘‘(1) BIOSIMILAR DEVELOPMENT PROGRAM

20 FEES.— 

21 ‘‘(A) INITIAL BIOSIMILAR BIOLOGICAL

22 PRODUCT DEVELOPMENT FEE.— 

23 ‘‘(i) IN GENERAL.—Each person that 

24 submits to the Secretary a meeting request 

25 described under clause (ii) or a clinical 


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1 protocol for an investigational new drug 

2 protocol described under clause (iii) shall 

3 pay for the product named in the meeting 

4 request or the investigational new drug ap5 plication the initial biosimilar biological 

6 product development fee established under 

7 subsection (b)(1)(A). 

8 ‘‘(ii) MEETING REQUEST.—The meet9 ing request defined in this clause is a re10 quest for a biosimilar biological product 

11 development meeting for a product. 

12 ‘‘(iii) CLINICAL PROTOCOL FOR IND.— 

13 A clinical protocol for an investigational 

14 new drug protocol described in this clause 

15 is a clinical protocol consistent with the 

16 provisions of section 505(i), including any 

17 regulations promulgated under section 

18 505(i), (referred to in this section as ‘in19 vestigational new drug application’) de20 scribing an investigation that the Secretary 

21 determines is intended to support a bio22 similar biological product application for a 

23 product. 


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1 ‘‘(iv) DUE DATE.—The initial bio2 similar biological product development fee 

3 shall be due by the earlier of the following: 

4 ‘‘(I) Not later than 5 days after 

5 the Secretary grants a request for a 

6 biosimilar biological product develop7 ment meeting. 

8 ‘‘(II) The date of submission of 

9 an investigational new drug applica10 tion describing an investigation that 

11 the Secretary determines is intended 

12 to support a biosimilar biological 

13 product application. 

14 ‘‘(v) TRANSITION RULE.—Each per15 son that has submitted an investigational 

16 new drug application prior to the date of 

17 enactment of the Biosimilars User Fee Act 

18 of 2012 shall pay the initial biosimilar bio19 logical product development fee by the ear20 lier of the following: 

21 ‘‘(I) Not later than 60 days after 

22 the date of the enactment of the 

23 Biosimilars User Fee Act of 2012, if 

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1 scribes an investigation that is in2 tended to support a biosimilar biologi3 cal product application. 

4 ‘‘(II) Not later than 5 days after 

5 the Secretary grants a request for a 

6 biosimilar biological product develop7 ment meeting. 

8 ‘‘(B) ANNUAL BIOSIMILAR BIOLOGICAL

9 PRODUCT DEVELOPMENT FEE.— 

10 ‘‘(i) IN GENERAL.—A person that 

11 pays an initial biosimilar biological product 

12 development fee for a product shall pay for 

13 such product, beginning in the fiscal year 

14 following the fiscal year in which the initial 

15 biosimilar biological product development 

16 fee was paid, an annual fee established 

17 under subsection (b)(1)(B) for biosimilar 

18 biological product development (referred to 

19 in this section as ‘annual biosimilar bio20 logical product development fee’). 

21 ‘‘(ii) DUE DATE.—The annual bio22 similar biological product development pro23 gram fee for each fiscal year will be due on 

24 the later of— 


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1 ‘‘(I) the first business day on or 

2 after October 1 of each such year; or 

3 ‘‘(II) the first business day after 

4 the enactment of an appropriations 

5 Act providing for the collection and 

6 obligation of fees for such year under 

7 this section. 

8 ‘‘(iii) EXCEPTION.—The annual bio9 similar development program fee for each 

10 fiscal year will be due on the date specified 

11 in clause (ii), unless the person has— 

12 ‘‘(I) submitted a marketing appli13 cation for the biological product that 

14 was accepted for filing; or 

15 ‘‘(II) discontinued participation 

16 in the biosimilar biological product de17 velopment program for the product 

18 under subparagraph (C). 

19 ‘‘(C) DISCONTINUATION OF FEE OBLIGA20 TION.—A person may discontinue participation 

21 in the biosimilar biological product development 

22 program for a product effective October 1 of a 

23 fiscal year by, not later than August 1 of the 

24 preceding fiscal year— 


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1 ‘‘(i) if no investigational new drug ap2 plication concerning the product has been 

3 submitted, submitting to the Secretary a 

4 written declaration that the person has no 

5 present intention of further developing the 

6 product as a biosimilar biological product; 

7 or 

8 ‘‘(ii) if an investigational new drug 

9 application concerning the product has 

10 been submitted, by withdrawing the inves11 tigational new drug application in accord12 ance with part 312 of title 21, Code of 

13 Federal Regulations (or any successor reg14 ulations). 

15 ‘‘(D) REACTIVATION FEE.— 

16 ‘‘(i) IN GENERAL.—A person that has 

17 discontinued participation in the biosimilar 

18 biological product development program for 

19 a product under subparagraph (C) shall 

20 pay a fee (referred to in this section as ‘re21 activation fee’) by the earlier of the fol22 lowing: 

23 ‘‘(I) Not later than 5 days after 

24 the Secretary grants a request for a 

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1 ment meeting for the product (after 

2 the date on which such participation 

3 was discontinued). 

4 ‘‘(II) Upon the date of submis5 sion (after the date on which such 

6 participation was discontinued) of an 

7 investigational new drug application 

8 describing an investigation that the 

9 Secretary determines is intended to 

10 support a biosimilar biological product 

11 application for that product. 

12 ‘‘(ii) APPLICATION OF ANNUAL

13 FEE.—A person that pays a reactivation 

14 fee for a product shall pay for such prod15 uct, beginning in the next fiscal year, the 

16 annual biosimilar biological product devel17 opment fee under subparagraph (B). 

18 ‘‘(E) EFFECT OF FAILURE TO PAY BIO19 SIMILAR DEVELOPMENT PROGRAM FEES.— 

20 ‘‘(i) NO BIOSIMILAR BIOLOGICAL

21 PRODUCT DEVELOPMENT MEETINGS.—If a 

22 person has failed to pay an initial or an23 nual biosimilar biological product develop24 ment fee as required under subparagraph 

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1 quired under subparagraph (D), the Sec2 retary shall not provide a biosimilar bio3 logical product development meeting relat4 ing to the product for which fees are owed. 

5 ‘‘(ii) NO RECEIPT OF INVESTIGA6 TIONAL NEW DRUG APPLICATIONS.—Ex7 cept in extraordinary circumstances, the 

8 Secretary shall not consider an investiga9 tional new drug application to have been 

10 received under section 505(i)(2) if— 

11 ‘‘(I) the Secretary determines 

12 that the investigation is intended to 

13 support a biosimilar biological product 

14 application; and 

15 ‘‘(II) the sponsor has failed to 

16 pay an initial or annual biosimilar bio17 logical product development fee for 

18 the product as required under sub19 paragraph (A) or (B), or a reactiva20 tion fee as required under subpara21 graph (D). 

22 ‘‘(iii) FINANCIAL HOLD.—Notwith23 standing section 505(i)(2), except in ex24 traordinary circumstances, the Secretary 

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1 vestigation from continuing the investiga2 tion if— 

3 ‘‘(I) the Secretary determines 

4 that the investigation is intended to 

5 support a biosimilar biological product 

6 application; and 

7 ‘‘(II) the sponsor has failed to 

8 pay an initial or annual biosimilar bio9 logical product development fee for 

10 the product as required under sub11 paragraph (A) or (B), or a reactiva12 tion fee for the product as required 

13 under subparagraph (D). 

14 ‘‘(iv) NO ACCEPTANCE OF BIOSIMILAR

15 BIOLOGICAL PRODUCT APPLICATIONS OR

16 SUPPLEMENTS.—If a person has failed to 

17 pay an initial or annual biosimilar biologi18 cal product development fee as required 

19 under subparagraph (A) or (B), or a reac20 tivation fee as required under subpara21 graph (D), any biosimilar biological prod22 uct application or supplement submitted by 

23 that person shall be considered incomplete 

24 and shall not be accepted for filing by the 


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1 Secretary until all such fees owed by such 

2 person have been paid. 

3 ‘‘(F) LIMITS REGARDING BIOSIMILAR DE4 VELOPMENT PROGRAM FEES.— 

5 ‘‘(i) NO REFUNDS.—The Secretary 

6 shall not refund any initial or annual bio7 similar biological product development fee 

8 paid under subparagraph (A) or (B), or 

9 any reactivation fee paid under subpara10 graph (D). 

11 ‘‘(ii) NO WAIVERS, EXEMPTIONS, OR

12 REDUCTIONS.—The Secretary shall not 

13 grant a waiver, exemption, or reduction of 

14 any initial or annual biosimilar biological 

15 product development fee due or payable 

16 under subparagraph (A) or (B), or any re17 activation fee due or payable under sub18 paragraph (D). 

19 ‘‘(2) BIOSIMILAR BIOLOGICAL PRODUCT APPLI20 CATION AND SUPPLEMENT FEE.— 

21 ‘‘(A) IN GENERAL.—Each person that sub22 mits, on or after October 1, 2012, a biosimilar 

23 biological product application or a supplement 

24 shall be subject to the following fees: 


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1 ‘‘(i) A fee for a biosimilar biological 

2 product application that is equal to— 

3 ‘‘(I) the amount of the fee estab4 lished under subsection (b)(1)(D) for 

5 a biosimilar biological product applica6 tion; minus 

7 ‘‘(II) the cumulative amount of 

8 fees paid, if any, under subparagraphs 

9 (A), (B), and (D) of paragraph (1) 

10 for the product that is the subject of 

11 the application. 

12 ‘‘(ii) A fee for a biosimilar biological 

13 product application for which clinical data 

14 (other than comparative bioavailability 

15 studies) with respect to safety or effective16 ness are not required, that is equal to— 

17 ‘‘(I) half of the amount of the fee 

18 established under subsection (b)(1)(D) 

19 for a biosimilar biological product ap20 plication; minus 

21 ‘‘(II) the cumulative amount of 

22 fees paid, if any, under subparagraphs 

23 (A), (B), and (D) of paragraph (1) 

24 for that product. 


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1 ‘‘(iii) A fee for a supplement for which 

2 clinical data (other than comparative bio3 availability studies) with respect to safety 

4 or effectiveness are required, that is equal 

5 to half of the amount of the fee established 

6 under subsection (b)(1)(D) for a biosimilar 

7 biological product application. 

8 ‘‘(B) REDUCTION IN FEES.—Notwith9 standing section 204 of the Biosimilars User 

10 Fee Act of 2012, any person who pays a fee 

11 under subparagraph (A), (B), or (D) of para12 graph (1) for a product before October 1, 2017, 

13 but submits a biosimilar biological product ap14 plication for that product after such date, shall 

15 be entitled to the reduction of any biosimilar bi16 ological product application fees that may be 

17 assessed at the time when such biosimilar bio18 logical product application is submitted, by the 

19 cumulative amount of fees paid under subpara20 graphs (A), (B), and (D) of paragraph (1) for 

21 that product. 

22 ‘‘(C) PAYMENT DUE DATE.—Any fee re23 quired by subparagraph (A) shall be due upon 

24 submission of the application or supplement for 

25 which such fee applies. 


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1 ‘‘(D) EXCEPTION FOR PREVIOUSLY FILED

2 APPLICATION OR SUPPLEMENT.—If a biosimilar 

3 biological product application or supplement 

4 was submitted by a person that paid the fee for 

5 such application or supplement, was accepted 

6 for filing, and was not approved or was with7 drawn (without a waiver), the submission of a 

8 biosimilar biological product application or a 

9 supplement for the same product by the same 

10 person (or the person’s licensee, assignee, or 

11 successor) shall not be subject to a fee under 

12 subparagraph (A). 

13 ‘‘(E) REFUND OF APPLICATION FEE IF AP14 PLICATION REFUSED FOR FILING OR WITH15 DRAWN BEFORE FILING.—The Secretary shall 

16 refund 75 percent of the fee paid under this 

17 paragraph for any application or supplement 

18 which is refused for filing or withdrawn without 

19 a waiver before filing. 

20 ‘‘(F) FEES FOR APPLICATIONS PRE21 VIOUSLY REFUSED FOR FILING OR WITHDRAWN

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1 ing, shall be subject to the full fee under sub2 paragraph (A) upon being resubmitted or filed 

3 over protest, unless the fee is waived under sub4 section (c). 

5 ‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT ESTAB6 LISHMENT FEE.— 

7 ‘‘(A) IN GENERAL.—Except as provided in 

8 subparagraph (E)(ii), each person that is 

9 named as the applicant in a biosimilar biologi10 cal product application shall be assessed an an11 nual fee established under subsection (b)(1)(E) 

12 for each biosimilar biological product establish13 ment that is listed in the approved biosimilar 

14 biological product application as an establish15 ment that manufactures the biosimilar biologi16 cal product named in such application. 

17 ‘‘(B) ASSESSMENT IN FISCAL YEARS.—The 

18 establishment fee shall be assessed in each fis19 cal year for which the biosimilar biological prod20 uct named in the application is assessed a fee 

21 under paragraph (4) unless the biosimilar bio22 logical product establishment listed in the appli23 cation does not engage in the manufacture of 

24 the biosimilar biological product during such 

25 fiscal year. 


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1 ‘‘(C) DUE DATE.—The establishment fee 

2 for a fiscal year shall be due on the later of— 

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

4 October 1 of such fiscal year; or 

5 ‘‘(ii) the first business day after the 

6 enactment of an appropriations Act pro7 viding for the collection and obligation of 

8 fees for such fiscal year under this section. 

9 ‘‘(D) APPLICATION TO ESTABLISHMENT.— 

10 ‘‘(i) Each biosimilar biological product 

11 establishment shall be assessed only one 

12 fee per biosimilar biological product estab13 lishment, notwithstanding the number of 

14 biosimilar biological products manufac15 tured at the establishment, subject to 

16 clause (ii). 

17 ‘‘(ii) In the event an establishment is 

18 listed in a biosimilar biological product ap19 plication by more than one applicant, the 

20 establishment fee for the fiscal year shall 

21 be divided equally and assessed among the 

22 applicants whose biosimilar biological prod23 ucts are manufactured by the establish24 ment during the fiscal year and assessed 


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1 biosimilar biological product fees under 

2 paragraph (4). 

3 ‘‘(E) EXCEPTION FOR NEW PRODUCTS.— 

4 If, during the fiscal year, an applicant initiates 

5 or causes to be initiated the manufacture of a 

6 biosimilar biological product at an establish7 ment listed in its biosimilar biological product 

8 application— 

9 ‘‘(i) that did not manufacture the bio10 similar biological product in the previous 

11 fiscal year; and 

12 ‘‘(ii) for which the full biosimilar bio13 logical product establishment fee has been 

14 assessed in the fiscal year at a time before 

15 manufacture of the biosimilar biological 

16 product was begun, 

17 the applicant shall not be assessed a share of 

18 the biosimilar biological product establishment 

19 fee for the fiscal year in which the manufacture 

20 of the product began. 

21 ‘‘(4) BIOSIMILAR BIOLOGICAL PRODUCT FEE.— 

22 ‘‘(A) IN GENERAL.—Each person who is 

23 named as the applicant in a biosimilar biologi24 cal product application shall pay for each such 


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1 biosimilar biological product the annual fee es2 tablished under subsection (b)(1)(F). 

3 ‘‘(B) DUE DATE.—The biosimilar biologi4 cal product fee for a fiscal year shall be due on 

5 the later of— 

6 ‘‘(i) the first business day on or after 

7 October 1 of each such year; or 

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

9 enactment of an appropriations Act pro10 viding for the collection and obligation of 

11 fees for such year under this section. 

12 ‘‘(C) ONE FEE PER PRODUCT PER YEAR.— 

13 The biosimilar biological product fee shall be 

14 paid only once for each product for each fiscal 

15 year. 

16 ‘‘(b) FEE SETTING AND AMOUNTS.— 

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

18 the Secretary shall, 60 days before the start of each 

19 fiscal year that begins after September 30, 2012, es20 tablish, for the next fiscal year, the fees under sub21 section (a). Except as provided in subsection (c), 

22 such fees shall be in the following amounts: 

23 ‘‘(A) INITIAL BIOSIMILAR BIOLOGICAL

24 PRODUCT DEVELOPMENT FEE.—The initial bio25 similar biological product development fee under 


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1 subsection (a)(1)(A) for a fiscal year shall be 

2 equal to 10 percent of the amount established 

3 under section 736(c)(5) for a human drug ap4 plication described in section 736(a)(1)(A)(i) 

5 for that fiscal year. 

6 ‘‘(B) ANNUAL BIOSIMILAR BIOLOGICAL

7 PRODUCT DEVELOPMENT FEE.—The annual 

8 biosimilar biological product development fee 

9 under subsection (a)(1)(B) for a fiscal year 

10 shall be equal to 10 percent of the amount es11 tablished under section 736(c)(5) for a human 

12 drug application described in section 

13 736(a)(1)(A)(i) for that fiscal year. 

14 ‘‘(C) REACTIVATION FEE.—The reactiva15 tion fee under subsection (a)(1)(D) for a fiscal 

16 year shall be equal to 20 percent of the amount 

17 of the fee established under section 736(c)(5) 

18 for a human drug application described in sec19 tion 736(a)(1)(A)(i) for that fiscal year. 

20 ‘‘(D) BIOSIMILAR BIOLOGICAL PRODUCT

21 APPLICATION FEE.—The biosimilar biological 

22 product application fee under subsection (a)(2) 

23 for a fiscal year shall be equal to the amount 

24 established under section 736(c)(5) for a 


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1 human drug application described in section 

2 736(a)(1)(A)(i) for that fiscal year. 

3 ‘‘(E) BIOSIMILAR BIOLOGICAL PRODUCT

4 ESTABLISHMENT FEE.—The biosimilar biologi5 cal product establishment fee under subsection 

6 (a)(3) for a fiscal year shall be equal to the 

7 amount established under section 736(c)(5) for 

8 a prescription drug establishment for that fiscal 

9 year. 

10 ‘‘(F) BIOSIMILAR BIOLOGICAL PRODUCT

11 FEE.—The biosimilar biological product fee 

12 under subsection (a)(4) for a fiscal year shall be 

13 equal to the amount established under section 

14 736(c)(5) for a prescription drug product for 

15 that fiscal year. 

16 ‘‘(2) LIMIT.—The total amount of fees charged 

17 for a fiscal year under this section may not exceed 

18 the total amount for such fiscal year of the costs of 

19 resources allocated for the process for the review of 

20 biosimilar biological product applications. 

21 ‘‘(c) APPLICATION FEE WAIVER FOR SMALL BUSI22 NESS.— 

23 ‘‘(1) WAIVER OF APPLICATION FEE.—The Sec24 retary shall grant to a person who is named in a bio25 similar biological product application a waiver from 


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1 the application fee assessed to that person under 

2 subsection (a)(2)(A) for the first biosimilar biologi3 cal product application that a small business or its 

4 affiliate submits to the Secretary for review. After a 

5 small business or its affiliate is granted such a waiv6 er, the small business or its affiliate shall pay— 

7 ‘‘(A) application fees for all subsequent 

8 biosimilar biological product applications sub9 mitted to the Secretary for review in the same 

10 manner as an entity that is not a small busi11 ness; and 

12 ‘‘(B) all supplement fees for all supple13 ments to biosimilar biological product applica14 tions submitted to the Secretary for review in 

15 the same manner as an entity that is not a 

16 small business. 

17 ‘‘(2) CONSIDERATIONS.—In determining wheth18 er to grant a waiver of a fee under paragraph (1), 

19 the Secretary shall consider only the circumstances 

20 and assets of the applicant involved and any affiliate 

21 of the applicant. 

22 ‘‘(3) SMALL BUSINESS DEFINED.—In this sub23 section, the term ‘small business’ means an entity 

24 that has fewer than 500 employees, including em25 ployees of affiliates, and does not have a drug prodVerDate Mar 15 2010 04:33 Feb 09, 2012 Jkt 019200 PO 00000 Frm 00079 Fmt 6652 Sfmt 6201 E:\BILLS\H3988.IH H3988

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1 uct that has been approved under a human drug ap2 plication (as defined in section 735) or a biosimilar 

3 biological product application (as defined in section 

4 744G(4)) and introduced or delivered for introduc5 tion into interstate commerce. 

6 ‘‘(d) EFFECT OF FAILURE TO PAY FEES.—A bio7 similar biological product application or supplement sub8 mitted by a person subject to fees under subsection (a) 

9 shall be considered incomplete and shall not be accepted 

10 for filing by the Secretary until all fees owed by such per11 son have been paid. 

12 ‘‘(e) CREDITING AND AVAILABILITY OF FEES.— 

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

14 fees authorized under subsection (a) shall be col15 lected and available for obligation only to the extent 

16 and in the amount provided in advance in appropria17 tions Acts. Such fees are authorized to remain avail18 able until expended. Such sums as may be necessary 

19 may be transferred from the Food and Drug Admin20 istration salaries and expenses appropriation account 

21 without fiscal year limitation to such appropriation 

22 account for salaries and expenses with such fiscal 

23 year limitation. The sums transferred shall be avail24 able solely for the process for the review of bio25 similar biological product applications. 


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1 ‘‘(2) COLLECTIONS AND APPROPRIATION

2 ACTS.— 

3 ‘‘(A) IN GENERAL.—Subject to subpara4 graphs (C) and (D), the fees authorized by this 

5 section shall be collected and available in each 

6 fiscal year in an amount not to exceed the 

7 amount specified in appropriation Acts, or oth8 erwise made available for obligation for such 

9 fiscal year. 

10 ‘‘(B) USE OF FEES AND LIMITATION.— 

11 The fees authorized by this section shall be 

12 available for a fiscal year beginning after fiscal 

13 year 2012 to defray the costs of the process for 

14 the review of biosimilar biological product appli15 cations (including such costs for an additional 

16 number of full-time equivalent positions in the 

17 Department of Health and Human Services to 

18 be engaged in such process), only if the Sec19 retary allocates for such purpose an amount for 

20 such fiscal year (excluding amounts from fees 

21 collected under this section) no less than 

22 $20,000,000, multiplied by the adjustment fac23 tor applicable to the fiscal year involved. 

24 ‘‘(C) FEE COLLECTION DURING FIRST

25 PROGRAM YEAR.—Until the date of enactment 


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1 of an Act making appropriations through Sep2 tember 30, 2013, for the salaries and expenses 

3 account of the Food and Drug Administration, 

4 fees authorized by this section for fiscal year 

5 2013 may be collected and shall be credited to 

6 such account and remain available until ex7 pended. 

8 ‘‘(D) PROVISION FOR EARLY PAYMENTS IN

9 SUBSEQUENT YEARS.—Payment of fees author10 ized under this section for a fiscal year (after 

11 fiscal year 2013), prior to the due date for such 

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

14 a prior year appropriations Act. 

15 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

16 For each of fiscal years 2013 through 2017, there 

17 is authorized to be appropriated for fees under this 

18 section an amount equivalent to the total amount of 

19 fees assessed for such fiscal year under this section. 

20 ‘‘(f) 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. 


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1 ‘‘(g) WRITTEN REQUESTS FOR WAIVERS AND RE2 FUNDS.—To qualify for consideration for a waiver under 

3 subsection (c), or for a refund of any fee collected in ac4 cordance with subsection (a)(2)(A), a person shall submit 

5 to the Secretary a written request for such waiver or re6 fund not later than 180 days after such fee is due. 

7 ‘‘(h) CONSTRUCTION.—This section may not be con8 strued to require that the number of full-time equivalent 

9 positions in the Department of Health and Human Serv10 ices, for officers, employers, and advisory committees not 

11 engaged in the process of the review of biosimilar biologi12 cal product applications, be reduced to offset the number 

13 of officers, employees, and advisory committees so en14 gaged.’’. 

15 SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS. 

16 Part 8 of subchapter C of chapter VII, as amended 

17 by section 202 of this Act, is further amended by inserting 

18 after section 744H the following: 

19 ‘‘SEC. 744I. REAUTHORIZATION; REPORTING REQUIRE20 MENTS. 

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

22 year 2013, not later than 120 days after the end of each 

23 fiscal year for which fees are collected under this part, 

24 the Secretary shall prepare and submit to the Committee 

25 on Energy and Commerce of the House of Representatives 


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

2 Pensions of the Senate a report concerning the progress 

3 of the Food and Drug Administration in achieving the 

4 goals identified in the letters described in section 201(c) 

5 of the Biosimilars User Fee Act of 2012 during such fiscal 

6 year and the future plans of the Food and Drug Adminis7 tration for meeting such goals. The report for a fiscal year 

8 shall include information on all previous cohorts for which 

9 the Secretary has not given a complete response on all 

10 biosimilar biological product applications and supplements 

11 in the cohort. 

12 ‘‘(b) FISCAL REPORT.—Not later than 120 days after 

13 the end of fiscal year 2013 and each subsequent fiscal year 

14 for which fees are collected under this part, the Secretary 

15 shall prepare and submit to the Committee on Energy and 

16 Commerce of the House of Representatives and the Com17 mittee on Health, Education, Labor, and Pensions of the 

18 Senate a report on the implementation of the authority 

19 for such fees during such fiscal year and the use, by the 

20 Food and Drug Administration, of the fees collected for 

21 such fiscal year. 

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

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

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

25 Food and Drug Administration. 


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1 ‘‘(d) STUDY.— 

2 ‘‘(1) IN GENERAL.—The Secretary shall con3 tract with an independent accounting or consulting 

4 firm to study the workload volume and full costs as5 sociated with the process for the review of biosimilar 

6 biological product applications. 

7 ‘‘(2) INTERIM RESULTS.—Not later than June 

8 1, 2015, the Secretary shall publish, for public com9 ment, interim results of the study described under 

10 paragraph (1). 

11 ‘‘(3) FINAL RESULTS.—Not later than Sep12 tember 30, 2016, the Secretary shall publish, for 

13 public comment, the final results of the study de14 scribed under paragraph (1). 

15 ‘‘(e) REAUTHORIZATION.— 

16 ‘‘(1) CONSULTATION.—In developing rec17 ommendations to present to the Congress with re18 spect to the goals described in subsection (a), and 

19 plans for meeting the goals, for the process for the 

20 review of biosimilar biological product applications 

21 for the first 5 fiscal years after fiscal year 2017, and 

22 for the reauthorization of this part for such fiscal 

23 years, the Secretary shall consult with— 

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


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

2 Labor, and Pensions of the Senate; 

3 ‘‘(C) scientific and academic experts; 

4 ‘‘(D) health care professionals; 

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

7 ‘‘(F) the regulated industry. 

8 ‘‘(2) PUBLIC REVIEW OF RECOMMENDA9 TIONS.—After negotiations with the regulated indus10 try, the Secretary shall— 

11 ‘‘(A) present the recommendations devel12 oped under paragraph (1) to the Congressional 

13 committees specified in such paragraph; 

14 ‘‘(B) publish such recommendations in the 

15 Federal Register; 

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

17 the public to provide written comments on such 

18 recommendations; 

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

20 may present its views on such recommenda21 tions; and 

22 ‘‘(E) after consideration of such public 

23 views and comments, revise such recommenda24 tions as necessary. 


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1 ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.— 

2 Not later than January 15, 2017, the Secretary 

3 shall transmit to the Congress the revised rec4 ommendations under paragraph (2), a summary of 

5 the views and comments received under such para6 graph, and any changes made to the recommenda7 tions in response to such views and comments.’’. 

8 SEC. 204. SUNSET DATES. 

9 (a) AUTHORIZATION.—The amendment made by sec10 tion 202 shall cease to be effective October 1, 2017. 

11 (b) REPORTING REQUIREMENTS.—The amendment 

12 made by section 203 shall cease to be effective January 

13 31, 2018. 

14 SEC. 205. EFFECTIVE DATE. 

15 (a) IN GENERAL.—Except as provided under sub16 section (b), the amendments made by this title shall take 

17 effect on the later of— 

18 (1) October 1, 2012; or 

19 (2) the date of the enactment of this title. 

20 (b) EXCEPTION.—Fees under part 7 of subchapter 

21 C of chapter VII of the Federal Food, Drug, and Cosmetic 

22 Act, as added by this title, shall be assessed for all bio23 similar biological product applications received on or after 

24 October 1, 2012, regardless of the date of the enactment 

25 of this title. 


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1 SEC. 206. SAVINGS CLAUSE. 

2 Notwithstanding section 106 of the Prescription 

3 Drug User Fee Amendments of 2007 (21 U.S.C. 379g 

4 note), and notwithstanding the amendments made by this 

5 title, part 2 of subchapter C of chapter VII of the Federal 

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

7 before the date of the enactment of this title, shall con8 tinue to be in effect with respect to human drug applica9 tions and supplements (as defined in such part as of such 

10 day) that were accepted by the Food and Drug Adminis11 tration for filing on or after October 1, 2007, but before 

12 October 1, 2012, with respect to assessing and collecting 

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

14 fiscal year 2013. 

15 SEC. 207. TECHNICAL AMENDMENT; CONFORMING AMEND16 MENT. 

17 Section 735(1)(B) (21 U.S.C. 379g(1)(B)) is amend18 ed by striking ‘‘or (k)’’. 

Æ 


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