I 
112TH CONGRESS 
2D SESSION 
H. R. 5651 
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend 
the user-fee programs for prescription drugs and for medical devices, 
to establish user-fee programs for generic drugs and biosimilars, and 
for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 9, 2012 
Mr. UPTON (for himself, Mr. WAXMAN, Mr. PITTS, Mr. PALLONE, Mr. BAR-
TON of Texas, and Mr. DINGELL) 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 
revise and extend the user-fee programs for prescription 
drugs and for medical devices, to establish user-fee pro-
grams for generic drugs and biosimilars, and for other 
purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Food and Drug Ad-
ministration Reform Act of 2012’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents of this Act is as follows: 
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Sec. 1. Short title. 
Sec. 2. Table of contents. 
Sec. 3. References in Act. 
TITLE I—FEES RELATING TO DRUGS 
Sec. 101. Short title; finding. 
Sec. 102. Definitions. 
Sec. 103. Authority to assess and use drug fees. 
Sec. 104. Reauthorization; reporting requirements. 
Sec. 105. Sunset dates. 
Sec. 106. Effective date. 
Sec. 107. Savings clause. 
TITLE II—MEDICAL DEVICE USER FEE AMENDMENTS OF 2012 
Sec. 201. Short title; findings. 
Sec. 202. Definitions. 
Sec. 203. Authority to assess and use device fees. 
Sec. 204. Reauthorization; reporting requirements. 
Sec. 205. Savings clause. 
Sec. 206. Effective date. 
Sec. 207. Sunset clause. 
Sec. 208. Streamlined hiring authority to support activities related to the proc-
ess for the review of device applications. 
TITLE III—FEES RELATING TO GENERIC DRUGS 
Sec. 301. Short title. 
Sec. 302. Authority to assess and use human generic drug fees. 
Sec. 303. Reauthorization; reporting requirements. 
Sec. 304. Sunset dates. 
Sec. 305. Effective date. 
Sec. 306. Amendment with respect to misbranding. 
Sec. 307. Streamlined hiring authority to support activities related to human 
generic drugs. 
TITLE IV—FEES RELATING TO BIOSIMILAR BIOLOGICAL 
PRODUCTS 
Sec. 401. Short title; finding. 
Sec. 402. Fees relating to biosimilar biological products. 
Sec. 403. Reauthorization; reporting requirements. 
Sec. 404. Sunset dates. 
Sec. 405. Effective date. 
Sec. 406. Savings clause. 
Sec. 407. Conforming amendment. 
TITLE V—REAUTHORIZATION OF BEST PHARMACEUTICALS FOR 
CHILDREN ACT AND PEDIATRIC RESEARCH EQUITY ACT 
Sec. 501. Permanent extension of Best Pharmaceuticals for Children Act and 
Pediatric Research Equity Act. 
Sec. 502. Food and Drug Administration Report. 
Sec. 503. Internal Committee for Review of Pediatric Plans, Assessments, De-
ferrals, Deferral Extensions, and Waivers. 
Sec. 504. Staff of Office of Pediatric Therapeutics. 
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Sec. 505. Continuation of operation of Pediatric Advisory Committee. 
Sec. 506. Pediatric Subcommittee of the Oncologic Drugs Advisory Committee. 
TITLE VI—FOOD AND DRUG ADMINISTRATION ADMINISTRATIVE 
REFORMS 
Sec. 601. Public participation in issuance of FDA guidance documents. 
Sec. 602. Conflicts of interest. 
Sec. 603. Electronic submission of applications. 
Sec. 604. Notification of FDA intent to regulate laboratory-developed tests. 
TITLE VII—MEDICAL DEVICE REGULATORY IMPROVEMENTS 
Subtitle A—Premarket Predictability 
Sec. 701. Investigational device exemptions. 
Sec. 702. Clarification of least burdensome standard. 
Sec. 703. Agency documentation and review of significant decisions. 
Sec. 704. Transparency in clearance process. 
Sec. 705. Device Modifications Requiring Premarket Notification Prior to Mar-
keting. 
Subtitle B—Patients Come First 
Sec. 711. Establishment of schedule and promulgation of regulation. 
Sec. 712. Program to improve the device recall system. 
Subtitle C—Novel Device Regulatory Relief 
Sec. 721. Modification of de novo application process. 
Subtitle D—Keeping America Competitive Through Harmonization 
Sec. 731. Harmonization of device premarket review, inspection, and labeling 
symbols; report. 
Sec. 732. Participation in international fora. 
Subtitle E—FDA Renewing Efficiency From Outside Reviewer Management 
Sec. 741. Reauthorization of Third Party Review. 
Sec. 742. Reauthorization of third party inspection. 
Subtitle F—Humanitarian Device Reform 
Sec. 751. Expanded access to humanitarian use devices. 
Subtitle G—Records and Reports on Devices 
Sec. 761. Unique device identification system regulations. 
Sec. 762. Effective device sentinel program. 
Subtitle H—Miscellaneous 
Sec. 771. Custom devices. 
Sec. 772. Pediatric device reauthorization. 
Sec. 773. Report on regulation of health information technology. 
TITLE VIII—DRUG REGULATORY IMPROVEMENTS 
Subtitle A—Drug Supply Chain 
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Sec. 801. Registration of producers of drugs. 
Sec. 802. Inspection of drugs. 
Sec. 803. Drug supply quality and safety. 
Sec. 804. Prohibition against delaying, denying, limiting, or refusing inspection. 
Sec. 805. Destruction of adulterated, misbranded, or counterfeit drugs offered 
for import. 
Sec. 806. Administrative detention. 
Sec. 807. Enhanced criminal penalty for counterfeit drugs. 
Sec. 808. Unique facility identification number. 
Sec. 809. Documentation for admissibility of imports. 
Sec. 810. Registration of commercial importers. 
Sec. 811. Notification. 
Sec. 812. Exchange of information. 
Sec. 813. Extraterritorial jurisdiction. 
Sec. 814. Protection against intentional adulteration. 
Sec. 815. Records for inspection. 
Subtitle B—Medical Gas Safety 
Sec. 821. Regulation of medical gases. 
Sec. 822. Changes to regulations. 
Sec. 823. Rules of construction. 
Subtitle C—Generating Antibiotic Incentives Now 
Sec. 831. Extension of exclusivity period for drugs. 
Sec. 832. Study on incentives for qualified infectious disease biological prod-
ucts. 
Sec. 833. Clinical trials. 
Sec. 834. Reassessment of qualified infectious disease product incentives in 5 
years. 
Sec. 835. Guidance on pathogen-focused antibacterial drug development. 
Subtitle D—Accelerated Approval 
Sec. 841. Expedited approval of drugs for serious or life-threatening diseases 
or conditions. 
Sec. 842. Guidance; amended regulations. 
Sec. 843. Independent review. 
Subtitle E—Critical Path Reauthorization 
Sec. 851. Reauthorization of the critical path public-private partnerships. 
Subtitle F—Miscellaneous 
Sec. 861. Reauthorization of provision relating to exclusivity of certain drugs 
containing single enantiomers. 
Sec. 862. Extension of period for first applicant to obtain tentative approval 
without forfeiting 180-day exclusivity period. 
Sec. 863. Final agency action relating to petitions and civil actions. 
Sec. 864. Deadline for determination on certain petitions. 
Sec. 865. Rare pediatric disease priority review voucher incentive program. 
Sec. 866. Combating prescription drug abuse. 
Sec. 867. Assessment and modification of REMS. 
Sec. 868. Consultation with external experts on rare diseases, targeted thera-
pies, and genetic targeting of treatments. 
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Sec. 869. Breakthrough therapies. 
Sec. 870. Grants and Contracts for the Development of Orphan Drugs. 
TITLE IX—DRUG SHORTAGES 
Sec. 901. Discontinuance and interruptions of manufacturing of certain drugs. 
Sec. 902. Drug shortage list. 
Sec. 903. Quotas applicable to drugs in shortage. 
Sec. 904. Expedited review of major manufacturing changes for potential and 
verified shortages of drugs that are life-supporting, life-sus-
taining, or intended for use in the prevention of a debilitating 
disease or condition. 
Sec. 905. Study on drug shortages. 
Sec. 906. Annual report on drug shortages. 
Sec. 907. Attorney General report on drug shortages. 
Sec. 908. Hospital repackaging of drugs in shortage. 
SEC. 3. REFERENCES IN ACT. 
Except as otherwise specified, amendments made by 
this Act to a section or other provision of law are amend-
ments to such section or other provision of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 
TITLE I—FEES RELATING TO 
DRUGS 
SEC. 101. SHORT TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the 
‘‘Prescription Drug User Fee Amendments of 2012’’. 
(b) FINDING.—The Congress finds that the fees au-
thorized by the amendments made in this title will be dedi-
cated toward expediting the drug development process and 
the process for the review of human drug applications, in-
cluding postmarket drug safety activities, as set forth in 
the goals identified for purposes of part 2 of subchapter 
C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, in the letters from the Secretary of Health and 
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Human Services to the Chairman of the Committee on 
Health, Education, Labor, and Pensions of the Senate and 
the Chairman of the Committee on Energy and Commerce 
of the House of Representatives, as set forth in the Con-
gressional Record. 
SEC. 102. DEFINITIONS. 
Section 735(7) (21 U.S.C. 379g) is amended by strik-
ing ‘‘expenses incurred in connection with’’ and inserting 
‘‘expenses in connection with’’. 
SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES. 
Section 736 (21 U.S.C. 379h) is amended— 
(1) in subsection (a)— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘fiscal year 2008’’ and inserting 
‘‘fiscal year 2013’’; 
(B) in paragraph (1)(A)— 
(i) in clause (i), by striking ‘‘(c)(5)’’ 
inserting ‘‘(c)(4)’’; and 
(ii) in clause (ii), by striking ‘‘(c)(5)’’ 
inserting ‘‘(c)(4)’’; 
(C) in the matter following clause (ii) in 
paragraph (2)(A)— 
(i) by striking ‘‘(c)(5)’’ inserting 
‘‘(c)(4)’’; and 
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(ii) by striking ‘‘payable on or before 
October 1 of each year’’ and inserting 
‘‘due on the later of the first business day 
on or after October 1 of such fiscal year or 
the first business day after the enactment 
of an appropriations Act providing for the 
collection and obligation of fees for such 
fiscal year under this section’’; 
(D) in paragraph (3)— 
(i) in subparagraph (A)— 
(I) 
by 
striking 
‘‘subsection 
(c)(5)’’ 
and 
inserting 
‘‘subsection 
(c)(4)’’; and 
(II) by striking ‘‘payable on or 
before October 1 of each year.’’ and 
inserting ‘‘due on the later of the first 
business day on or after October 1 of 
each such fiscal year or the first busi-
ness day after the enactment of an 
appropriations Act providing for the 
collection and obligation of fees for 
each such fiscal year under this sec-
tion.’’; and 
(ii) by amending subparagraph (B) to 
read as follows: 
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‘‘(B) EXCEPTION.—A prescription drug 
product shall not be assessed a fee under sub-
paragraph (A) if such product is— 
‘‘(i) identified on the list compiled 
under section 505(j)(7)(A) with a potency 
described in terms of per 100 mL; 
‘‘(ii) the same product as another 
product that— 
‘‘(I) was approved under an ap-
plication filed under section 505(b) or 
505(j); and 
‘‘(II) is not in the list of discon-
tinued products compiled under sec-
tion 505(j)(7)(A); 
‘‘(iii) the same product as another 
product that was approved under an abbre-
viated application filed under section 507 
(as in effect on the day before the date of 
enactment of the Food and Drug Adminis-
tration Modernization Act of 1997); or 
‘‘(iv) the same product as another 
product that was approved under an abbre-
viated new drug application pursuant to 
regulations in effect prior to the implemen-
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tation of the Drug Price Competition and 
Patent Term Restoration Act of 1984.’’; 
(2) in subsection (b)— 
(A) in paragraph (1)— 
(i) in the language preceding subpara-
graph (A), by striking ‘‘fiscal years 2008 
through 2012’’ and inserting ‘‘fiscal years 
2013 through 2017’’; and 
(ii) in subparagraph (A), by striking 
‘‘$392,783,000; 
and’’ 
and 
inserting 
‘‘$693,099,000;’’; and 
(iii) by striking subparagraph (B) and 
inserting the following: 
‘‘(B) the dollar amount equal to the infla-
tion adjustment for fiscal year 2013 (as deter-
mined under paragraph (3)(A)); and 
‘‘(C) the dollar amount equal to the work-
load adjustment for fiscal year 2013 (as deter-
mined under paragraph (3)(B)).’’; and 
(B) by striking paragraphs (3) and (4) and 
inserting the following: 
‘‘(3) FISCAL YEAR 2013 INFLATION AND WORK-
LOAD ADJUSTMENTS.—For purposes of paragraph 
(1), the dollar amount of the inflation and workload 
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adjustments for fiscal year 2013 shall be determined 
as follows: 
‘‘(A) INFLATION ADJUSTMENT.—The infla-
tion adjustment for fiscal year 2013 shall be 
the sum of— 
‘‘(i) $652,709,000 multiplied by the 
result of an inflation adjustment calcula-
tion determined using the methodology de-
scribed in subsection (c)(1)(B); and 
‘‘(ii) $652,709,000 multiplied by the 
result of an inflation adjustment calcula-
tion determined using the methodology de-
scribed in subsection (c)(1)(C). 
‘‘(B) WORKLOAD
ADJUSTMENT.—Subject 
to subparagraph (C), the workload adjustment 
for fiscal 2013 shall be— 
‘‘(i) $652,709,000 plus the amount of 
the inflation adjustment calculated under 
subparagraph (A); multiplied by 
‘‘(ii) the amount (if any) by which a 
percentage workload adjustment for fiscal 
year 2013, as determined using the meth-
odology described in subsection (c)(2)(A), 
would exceed the percentage workload ad-
justment (as so determined) for fiscal year 
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2012, if both such adjustment percentages 
were calculated using the 5-year base pe-
riod consisting of fiscal years 2003 
through 2007. 
‘‘(C) 
LIMITATION.—Under 
no 
cir-
cumstances shall the adjustment under sub-
paragraph (B) result in fee revenues for fiscal 
year 2013 that are less than the sum of the 
amount under paragraph (1)(A) and the 
amount under paragraph (1)(B).’’; 
(3) by striking subsection (c) and inserting the 
following: 
‘‘(c) ADJUSTMENTS.— 
‘‘(1) INFLATION ADJUSTMENT.—For fiscal year 
2014 and subsequent fiscal years, the revenues es-
tablished in subsection (b) shall be adjusted by the 
Secretary by notice, published in the Federal Reg-
ister, for a fiscal year by the amount equal to the 
sum of— 
‘‘(A) one; 
‘‘(B) the average annual percent change in 
the cost, per full-time equivalent position of the 
Food and Drug Administration, of all personnel 
compensation and benefits paid with respect to 
such positions for the first 3 years of the pre-
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ceding 4 fiscal years, multiplied by the propor-
tion of personnel compensation and benefits 
costs to total costs of the process for the review 
of human drug applications (as defined in sec-
tion 735(6)) for the first 3 years of the pre-
ceding 4 fiscal years, and 
‘‘(C) the average annual percent change 
that occurred in the Consumer Price Index for 
urban consumers (Washington-Baltimore, DC– 
MD–VA–WV; Not Seasonally Adjusted; All 
items; Annual Index) for the first 3 years of the 
preceding 4 years of available data multiplied 
by the proportion of all costs other than per-
sonnel compensation and benefits costs to total 
costs of the process for the review of human 
drug applications (as defined in section 735(6)) 
for the first 3 years of the preceding 4 fiscal 
years. 
The adjustment made each fiscal year under this 
paragraph shall be added on a compounded basis to 
the sum of all adjustments made each fiscal year 
after fiscal year 2013 under this paragraph. 
‘‘(2) WORKLOAD
ADJUSTMENT.—For fiscal 
year 2014 and subsequent fiscal years, after the fee 
revenues established in subsection (b) are adjusted 
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for a fiscal year for inflation in accordance with 
paragraph (1), the fee revenues shall be adjusted 
further for such fiscal year to reflect changes in the 
workload of the Secretary for the process for the re-
view of human drug applications. With respect to 
such adjustment: 
‘‘(A) The adjustment shall be determined 
by the Secretary based on a weighted average 
of the change in the total number of human 
drug applications (adjusted for changes in re-
view activities, as described in the notice that 
the Secretary is required to publish in the Fed-
eral Register under this subparagraph), efficacy 
supplements, and manufacturing supplements 
submitted to the Secretary, and the change in 
the total number of active commercial investiga-
tional new drug applications (adjusted for 
changes in review activities, as so described) 
during the most recent 12-month period for 
which data on such submissions is available. 
The Secretary shall publish in the Federal Reg-
ister the fee revenues and fees resulting from 
the adjustment and the supporting methodolo-
gies. 
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‘‘(B) Under no circumstances shall the ad-
justment result in fee revenues for a fiscal year 
that are less than the sum of the amount under 
subsection (b)(1)(A) and the amount under 
subsection (b)(1)(B), as adjusted for inflation 
under paragraph (1). 
‘‘(C) The Secretary shall contract with an 
independent accounting or consulting firm to 
periodically review the adequacy of the adjust-
ment and publish the results of those reviews. 
The first review shall be conducted and pub-
lished by the end of fiscal year 2013 (to exam-
ine the performance of the adjustment since fis-
cal year 2009), and the second review shall be 
conducted and published by the end of fiscal 
year 2015 (to examine the continued perform-
ance of the adjustment). The reports shall 
evaluate whether the adjustment reasonably 
represents actual changes in workload volume 
and complexity and present options to dis-
continue, retain, or modify any elements of the 
adjustment. The reports shall be published for 
public comment. After review of the reports and 
receipt of public comments, the Secretary shall, 
if warranted, adopt appropriate changes to the 
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methodology. If the Secretary adopts changes to 
the methodology based on the first report, the 
changes shall be effective for the first fiscal 
year for which fees are set after the Secretary 
adopts such changes and each subsequent fiscal 
year. 
‘‘(3) FINAL
YEAR
ADJUSTMENT.—For fiscal 
year 2017, the Secretary may, in addition to adjust-
ments under this paragraph and paragraphs (1) and 
(2), further increase the fee revenues and fees estab-
lished in subsection (b) if such an adjustment is nec-
essary to provide for not more than 3 months of op-
erating reserves of carryover user fees for the proc-
ess for the review of human drug applications for 
the first 3 months of fiscal year 2018. If such an 
adjustment is necessary, the rationale for the 
amount of the increase shall be contained in the an-
nual notice establishing fee revenues and fees for fis-
cal year 2017. If the Secretary has carryover bal-
ances for such process in excess of 3 months of such 
operating reserves, the adjustment under this sub-
paragraph shall not be made. 
‘‘(4) ANNUAL
FEE
SETTING.—The Secretary 
shall, not later than 60 days before the start of each 
fiscal year that begins after September 30, 2012, es-
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tablish, for the next fiscal year, application, product, 
and establishment fees under subsection (a), based 
on the revenue amounts established under subsection 
(b) and the adjustments provided under this sub-
section. 
‘‘(5) LIMIT.—The total amount of fees charged, 
as adjusted under this subsection, for a fiscal year 
may not exceed the total costs for such fiscal year 
for the resources allocated for the process for the re-
view of human drug applications.’’; and 
(4) in subsection (g)— 
(A) in paragraph (1), by striking ‘‘Fees 
authorized’’ and inserting ‘‘Subject to para-
graph (2)(C), fees authorized’’; 
(B) in paragraph (2)— 
(i) in subparagraph (A)(i), by striking 
‘‘shall be retained’’ and inserting ‘‘shall be 
collected and available’’; 
(ii) in subparagraph (A)(ii), by strik-
ing ‘‘shall only be collected and available’’ 
and inserting ‘‘shall be available’’; and 
(iii) by adding at the end the fol-
lowing new subparagraph: 
‘‘(C) PROVISION FOR EARLY PAYMENTS.— 
Payment of fees authorized under this section 
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for a fiscal year, prior to the due date for such 
fees, may be accepted by the Secretary in ac-
cordance with authority provided in advance in 
a prior year appropriations Act.’’; 
(C) in paragraph (3), by striking ‘‘fiscal 
years 2008 through 2012’’ and inserting ‘‘fiscal 
years 2013 through 2017’’; and 
(D) in paragraph (4)— 
(i) by striking ‘‘fiscal years 2008 
through 2010’’ and inserting ‘‘fiscal years 
2013 through 2015’’; 
(ii) by striking ‘‘fiscal year 2011’’ and 
inserting ‘‘fiscal year 2016’’; 
(iii) by striking ‘‘fiscal years 2008 
though 2011’’ and inserting ‘‘fiscal years 
2013 through 2016’’; and 
(iv) by striking ‘‘fiscal year 2012’’ 
and inserting ‘‘fiscal year 2017’’. 
SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 736B (21 U.S.C. 379h–2) is amended— 
(1) by amending subsection (a) to read as fol-
lows: 
‘‘(a) PERFORMANCE REPORT.— 
‘‘(1) IN GENERAL.—Beginning with fiscal year 
2013, not later than 120 days after the end of each 
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fiscal year for which fees are collected under this 
part, the Secretary shall prepare and submit to the 
Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a re-
port concerning— 
‘‘(A) the progress of the Food and Drug 
Administration in achieving the goals identified 
in the letters described in section 101(b) of the 
Prescription Drug User Fee Amendments of 
2012 during such fiscal year and the future 
plans of the Food and Drug Administration for 
meeting the goals, including the status of the 
independent assessment described in such let-
ters; and 
‘‘(B) the progress of the Center for Drug 
Evaluation and Research and the Center for 
Biologics Evaluation and Research in achieving 
the goals, and future plans for meeting the 
goals, including, for each review division— 
‘‘(i) the number of original standard 
new drug applications and biologics license 
applications filed per fiscal year for each 
review division; 
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‘‘(ii) the number of original priority 
new drug applications and biologics license 
applications filed per fiscal year for each 
review division; 
‘‘(iii) the number of standard efficacy 
supplements filed per fiscal year for each 
review division; 
‘‘(iv) the number of priority efficacy 
supplements filed per fiscal year for each 
review division; 
‘‘(v) the number of applications filed 
for review under accelerated approval per 
fiscal year for each review division; 
‘‘(vi) the number of applications filed 
for review as fast track products per fiscal 
year for each review division; and 
‘‘(vii) the number of applications filed 
for orphan-designated products per fiscal 
year for each review division. 
‘‘(2) INCLUSION.—The report under this sub-
section for a fiscal year shall include information on 
all previous cohorts for which the Secretary has not 
given a complete response on all human drug appli-
cations and supplements in the cohort.’’. 
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(2) in subsection (b), by striking ‘‘2008’’ and 
inserting ‘‘2013’’; and 
(3) in subsection (d), by striking ‘‘2012’’ each 
place it appears and inserting ‘‘2017’’. 
SEC. 105. SUNSET DATES. 
(a) AUTHORIZATION.—Sections 735 and 736 (21 
U.S.C. 379g; 379h) are repealed October 1, 2017. 
(b) REPORTING REQUIREMENTS.—Section 736B (21 
U.S.C. 379h–2) is repealed January 31, 2018. 
(c) PREVIOUS SUNSET PROVISION.—Section 106 of 
the Prescription Drug User Fee Amendments of 2007 
(Title I of Public Law 110–85) is repealed. 
(d) TECHNICAL CLARIFICATIONS.— 
(1) Effective September 30, 2007, section 508 
of the Prescription Drug User Fee Amendments Act 
of 2002 (Title V of Public Law 107–188) is re-
pealed. 
(2) Effective September 30, 2002, section 107 
of the Food and Drug Administration Modernization 
Act of 1997 (Public Law 105–115) is repealed. 
(3) Effective September 30, 1997, section 105 
of the Prescription Drug User Fee Act of 1992 
(Public Law 102–571) is repealed. 
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SEC. 106. EFFECTIVE DATE. 
The amendments made by this title shall take effect 
on October 1, 2012, or the date of the enactment of this 
Act, whichever is later, except that fees under part 2 of 
subchapter C of chapter VII of the Federal Food, Drug, 
and Cosmetic Act shall be assessed for all human drug 
applications received on or after October 1, 2012, regard-
less of the date of the enactment of this Act. 
SEC. 107. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this title, 
part 2 of subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act, as in effect on the day before 
the date of the enactment of this title, shall continue to 
be in effect with respect to human drug applications and 
supplements (as defined in such part as of such day) that 
on or after October 1, 2007, but before October 1, 2012, 
were accepted by the Food and Drug Administration for 
filing with respect to assessing and collecting any fee re-
quired by such part for a fiscal year prior to fiscal year 
2012. 
TITLE II—MEDICAL DEVICE 
USER FEE AMENDMENTS OF 2012 
SEC. 201. SHORT TITLE; FINDINGS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Medical Device User Fee Amendments of 2012’’. 
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(b) FINDINGS.—The Congress finds that the fees au-
thorized under the amendments made by this title will be 
dedicated toward expediting the process for the review of 
device applications and for assuring the safety and effec-
tiveness of devices, as set forth in the goals identified for 
purposes of part 3 of subchapter C of chapter VII of the 
Federal Food, Drug, and Cosmetic Act in the letters from 
the Secretary of Health and Human Services to the Chair-
man of the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Chairman of the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives, as set forth in the Congressional Record. 
SEC. 202. DEFINITIONS. 
Section 737 (21 U.S.C. 379i) is amended— 
(1) in paragraph (9), by striking ‘‘incurred’’ 
after ‘‘expenses’’; 
(2) in paragraph (10), by striking ‘‘October 
2001’’ and inserting ‘‘October 2011’’; and 
(3) in paragraph (13), by striking ‘‘is required 
to register’’ and all that follows through the end of 
paragraph (13) and inserting the following: ‘‘is reg-
istered (or is required to register) with the Secretary 
under section 510 because such establishment is en-
gaged in the manufacture, preparation, propagation, 
compounding, or processing of a device.’’. 
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SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES. 
(a) TYPES OF FEES.—Section 738(a) (21 U.S.C. 
379j(a)) is amended— 
(1) in paragraph (1), by striking ‘‘fiscal year 
2008’’ and inserting ‘‘fiscal year 2013’’; 
(2) in paragraph (2)(A)— 
(A) in the matter preceding clause (i)— 
(i) by striking ‘‘subsections (d) and 
(e)’’ and inserting ‘‘subsections (d), (e), 
and (f)’’; 
(ii) by striking ‘‘October 1, 2002’’ and 
inserting ‘‘October 1, 2012’’; and 
(iii) by striking ‘‘subsection (c)(1)’’ 
and inserting ‘‘subsection (c)’’; and 
(B) in clause (viii), by striking ‘‘1.84’’ and 
inserting ‘‘2’’; and 
(3) in paragraph (3)— 
(A) in subparagraph (A), by inserting 
‘‘and subsection (f)’’ after ‘‘subparagraph (B)’’; 
and 
(B) in subparagraph (C), by striking ‘‘ini-
tial registration’’ and all that follows through 
‘‘section 510.’’ and inserting ‘‘later of— 
‘‘(i) the initial or annual registration 
(as applicable) of the establishment under 
section 510; or 
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‘‘(ii) the first business day after the 
date of enactment of an appropriations Act 
providing for the collection and obligation 
of fees for such year under this section.’’. 
(b) FEE AMOUNTS.—Section 738(b) (21 U.S.C. 
379j(b)) is amended to read as follows: 
‘‘(b) FEE AMOUNTS.— 
‘‘(1) IN GENERAL.—Subject to subsections (c), 
(d), (e), (f), and (i), for each of fiscal years 2013 
through 2017, fees under subsection (a) shall be de-
rived from the base fee amounts specified in para-
graph (2), to generate the total revenue amounts 
specified in paragraph (3). 
‘‘(2) BASE
FEE
AMOUNTS
SPECIFIED.—For 
purposes of paragraph (1), the base fee amounts 
specified in this paragraph are as follows: 
‘‘Fee Type 
Fiscal 
Year 
2013 
Fiscal 
Year 
2014 
Fiscal 
Year 
2015 
Fiscal 
Year 
2016 
Fiscal 
Year 
2017 
Premarket Application ........................
$248,000 
$252,960 
$258,019 
$263,180 
$268,443 
Establishment Registration ................
$2,575 
$3,200 
$3,750 
$3,872 
$3,872 
‘‘(3) TOTAL
REVENUE
AMOUNTS.—For pur-
poses of paragraph (1), the total revenue amounts 
specified in this paragraph are as follows: 
‘‘(A) $97,722,301 for fiscal year 2013. 
‘‘(B) $112,580,497 for fiscal year 2014. 
‘‘(C) $125,767,107 for fiscal year 2015. 
‘‘(D) $129,339,949 for fiscal year 2016. 
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‘‘(E) $130,184,348 for fiscal year 2017.’’. 
(c) ANNUAL FEE SETTING; ADJUSTMENTS.—Section 
738(c) (21 U.S.C. 379j(c)) is amended— 
(1) in the subsection heading, by inserting ‘‘; 
ADJUSTMENTS’’ after ‘‘SETTING’’; 
(2) by striking paragraphs (1) and (2); 
(3) by redesignating paragraphs (3) and (4) as 
paragraphs (4) and (5), respectively; and 
(4) by inserting before paragraph (4), as so re-
designated, the following: 
‘‘(1) IN
GENERAL.—The Secretary shall, 60 
days before the start of each fiscal year after Sep-
tember 30, 2012, establish fees under subsection (a), 
based on amounts specified under subsection (b) and 
the adjustments provided under this subsection, and 
publish such fees, and the rationale for any adjust-
ments to such fees, in the Federal Register. 
‘‘(2) INFLATION ADJUSTMENTS.— 
‘‘(A) ADJUSTMENT
TO
TOTAL
REVENUE 
AMOUNTS.—For fiscal year 2014 and each sub-
sequent fiscal year, the Secretary shall adjust 
the total revenue amount specified in subsection 
(b)(3) for such fiscal year by multiplying such 
amount by the applicable inflation adjustment 
under subparagraph (B) for such year. 
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‘‘(B) APPLICABLE
INFLATION
ADJUST-
MENT TO TOTAL REVENUE AMOUNTS.—The ap-
plicable inflation adjustment for a fiscal year 
is— 
‘‘(i) for fiscal year 2014, the base in-
flation adjustment under subparagraph (C) 
for such fiscal year; and 
‘‘(ii) for fiscal year 2015 and each 
subsequent fiscal year, the product of— 
‘‘(I) the base inflation adjust-
ment under subparagraph (C) for 
such fiscal year; and 
‘‘(II) the product of the base in-
flation adjustment under subpara-
graph (C) for each of the fiscal years 
preceding such fiscal year, beginning 
with fiscal year 2014. 
‘‘(C) BASE
INFLATION
ADJUSTMENT
TO 
TOTAL REVENUE AMOUNTS.— 
‘‘(i) IN GENERAL.—Subject to further 
adjustment under clause (ii), the base in-
flation adjustment for a fiscal year is the 
sum of one plus— 
‘‘(I) the average annual percent 
change in the cost, per full-time equiv-
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alent position of the Food and Drug 
Administration, of all personnel com-
pensation and benefits paid with re-
spect to such positions for the first 3 
years of the preceding 4 fiscal years, 
multiplied by 0.60; and 
‘‘(II) the average annual percent 
change that occurred in the Consumer 
Price Index for urban consumers 
(Washington-Baltimore, DC–MD–VA– 
WV; Not Seasonally Adjusted; All 
items; Annual Index) for the first 3 
years of the preceding 4 years of 
available data multiplied by 0.40. 
‘‘(ii) LIMITATIONS.—For purposes of 
subparagraph (B), if the base inflation ad-
justment for a fiscal year under clause 
(i)— 
‘‘(I) is less than 1, such adjust-
ment shall be considered to be equal 
to 1; or 
‘‘(II) is greater than 1.04, such 
adjustment shall be considered to be 
equal to 1.04. 
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‘‘(D) 
ADJUSTMENT
TO
BASE
FEE 
AMOUNTS.—For each of fiscal years 2014 
through 2017, the base fee amounts specified in 
subsection (b)(2) shall be adjusted as needed, 
on a uniform proportionate basis, to generate 
the total revenue amounts under subsection 
(b)(3), as adjusted for inflation under subpara-
graph (A). 
‘‘(3) VOLUME-BASED ADJUSTMENTS TO ESTAB-
LISHMENT REGISTRATION BASE FEES.—For each of 
fiscal years 2014 through 2017, after the base fee 
amounts specified in subsection (b)(2) are adjusted 
under paragraph (2)(D), the base establishment reg-
istration fee amounts specified in such subsection 
shall be further adjusted, as the Secretary estimates 
is necessary in order for total fee collections for such 
fiscal year to generate the total revenue amounts, as 
adjusted under paragraph (2).’’. 
(d) FEE WAIVER OR REDUCTION.—Section 738 (21 
U.S.C. 379j) is amended by— 
(1) redesignating subsections (f) through (k) as 
subsections (g) through (l), respectively; and 
(2) by inserting after subsection (e) the fol-
lowing new subsection (f): 
‘‘(f) FEE WAIVER OR REDUCTION.— 
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‘‘(1) IN GENERAL.—The Secretary may, at the 
Secretary’s sole discretion, grant a waiver or reduc-
tion of fees under subsection (a)(2) or (a)(3) if the 
Secretary finds that such waiver or reduction is in 
the interest of public health. 
‘‘(2) LIMITATION.—The sum of all fee waivers 
or reductions granted by the Secretary in any fiscal 
year under paragraph (1) shall not exceed 2 percent 
of the total fee revenue amounts established for such 
year under subsection (c). 
‘‘(3) DURATION.—The authority provided by 
this subsection terminates October 1, 2017.’’. 
(e) CONDITIONS.—Section 738(h)(1)(A) (21 U.S.C. 
379j(h)(1)(A)), as redesignated by subsection (d)(1), is 
amended by striking ‘‘$205,720,000’’ and inserting 
‘‘$280,587,000’’. 
(f) CREDITING AND AVAILABILITY OF FEES.—Sec-
tion 738(i) (21 U.S.C. 379j(i)), as redesignated by sub-
section (d)(1), is amended— 
(1) in paragraph (1), by striking ‘‘Fees author-
ized’’ and inserting ‘‘Subject to paragraph (2)(C), 
fees authorized’’; 
(2) in paragraph (2)— 
(A) in subparagraph (A)— 
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(i) in clause (i), by striking ‘‘shall be 
retained’’ and inserting ‘‘subject to sub-
paragraph (C), shall be collected and avail-
able’’; and 
(ii) in clause (ii)— 
(I) by striking ‘‘collected and’’ 
after ‘‘shall only be’’; and 
(II) by striking ‘‘fiscal year 
2002’’ and inserting ‘‘fiscal year 
2009’’; and 
(B) by adding at the end, the following: 
‘‘(C) PROVISION
FOR
EARLY
YEAR
PAY-
MENTS.—Payment of fees authorized under this 
section for a fiscal year, prior to the due date 
for such fees, may be accepted by the Secretary 
in accordance with authority provided in ad-
vance in a prior year appropriations Act.’’; 
(3) in paragraph (3), by amending to read as 
follows: 
‘‘(3) AUTHORIZATIONS OF APPROPRIATIONS.— 
For each of the fiscal years 2013 through 2017, 
there is authorized to be appropriated for fees under 
this section an amount equal to the total revenue 
amount specified under subsection (b)(3) for the fis-
cal year, as adjusted under subsection (c) and, for 
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fiscal year 2017 only, as further adjusted under 
paragraph (4).’’; and 
(4) in paragraph (4)— 
(A) by striking ‘‘fiscal years 2008, 2009, 
and 2010’’ and inserting ‘‘fiscal years 2013, 
2014, and 2015’’; 
(B) by striking ‘‘fiscal year 2011’’ and in-
serting ‘‘fiscal year 2016’’; 
(C) by striking ‘‘June 30, 2011’’ and in-
serting ‘‘June 30, 2016’’; 
(D) by striking ‘‘the amount of fees speci-
fied in aggregate in’’ and inserting ‘‘the cumu-
lative amount appropriated pursuant to’’; 
(E) by striking ‘‘aggregate amount in’’ be-
fore ‘‘excess shall be credited’’; and 
(F) by striking ‘‘fiscal year 2012’’ and in-
serting ‘‘fiscal year 2017’’. 
(g) 
CONFORMING
AMENDMENT.—Section 
515(c)(4)(A) (21 U.S.C. 360e(c)(4)(A)) is amended by 
striking ‘‘738(g)’’ and inserting ‘‘738(h)’’. 
SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS. 
(a) 
REAUTHORIZATION.—Section 
738A(b) 
(21 
U.S.C. 379j–1(b)) is amended— 
(1) in paragraph (1), by striking ‘‘2012’’ and 
inserting ‘‘2017’’; and 
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(2) in paragraph (5), by striking ‘‘2012’’ and 
inserting ‘‘2017’’. 
(b) PERFORMANCE REPORTS.—Section 738A(a) (21 
U.S.C. 379j–1(a)) is amended— 
(1) by striking paragraph (1) and inserting the 
following: 
‘‘(1) PERFORMANCE REPORT.— 
‘‘(A) IN GENERAL.—Beginning with fiscal 
year 2013, for each fiscal year for which fees 
are collected under this part, the Secretary 
shall prepare and submit to the Committee on 
Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Com-
merce of the House of Representatives annual 
reports concerning the progress of the Food 
and Drug Administration in achieving the goals 
identified in the letters described in section 
201(b) of the Medical Device User Fee Amend-
ments of 2012 during such fiscal year and the 
future plans of the Food and Drug Administra-
tion for meeting the goals. 
‘‘(B) PUBLICATION.—With regard to infor-
mation to be reported by the Food and Drug 
Administration to industry on a quarterly and 
annual basis pursuant to the letters described 
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in section 201(b) of the Medical Device User 
Fee Amendments Act of 2012, the Secretary 
shall make such information publicly available 
on the Internet Website of the Food and Drug 
Administration not later than 60 days after the 
end of each quarter or 120 days after the end 
of each fiscal year, respectively, to which such 
information applies. This information shall in-
clude the status of the independent assessment 
identified in the letters described in such sec-
tion 201(b). 
‘‘(C) UPDATES.—The Secretary shall in-
clude in each report under subparagraph (A) 
information on all previous cohorts for which 
the Secretary has not given a complete response 
on all device premarket applications and re-
ports, supplements, and premarket notifications 
in the cohort.’’; and 
(2) in paragraph (2), by striking ‘‘2008 
through 2012’’ and inserting ‘‘2013 through 2017’’. 
SEC. 205. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this title, 
part 3 of subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in 
effect on the day before the date of the enactment of this 
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title, shall continue to be in effect with respect to the sub-
missions listed in section 738(a)(2)(A) of such Act (as de-
fined in such part as of such day) that on or after October 
1, 2007, but before October 1, 2012, were accepted by 
the Food and Drug Administration for filing with respect 
to assessing and collecting any fee required by such part 
for a fiscal year prior to fiscal year 2013. 
SEC. 206. EFFECTIVE DATE. 
The amendments made by this title shall take effect 
on October 1, 2012, or the date of the enactment of this 
Act, whichever is later, except that fees under part 3 of 
subchapter C of chapter VII of the Federal Food, Drug, 
and Cosmetic Act shall be assessed for all submissions list-
ed in section 738(a)(2)(A) of such Act received on or after 
October 1, 2012, regardless of the date of the enactment 
of this Act. 
SEC. 207. SUNSET CLAUSE. 
(a) IN GENERAL.—Sections 737 and 738 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 739i; 739j) 
shall cease to be effective October 1, 2017. Section 738A 
(21 U.S.C. 739j–1) of the Federal Food, Drug, and Cos-
metic Act (regarding reauthorization and reporting re-
quirements) are repealed January 31, 2018. 
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(b) PREVIOUS SUNSET PROVISION.—Section 217 of 
the Medical Device User Fee Amendments of 2007 (Title 
II of Public Law 110–85) is repealed. 
(c) TECHNICAL
CLARIFICATION.—Effective Sep-
tember 30, 2007, section 107 of the Medical Device User 
Fee and Modernization Act of 2002 (Public Law 107– 
250) is repealed. 
SEC. 208. STREAMLINED HIRING AUTHORITY TO SUPPORT 
ACTIVITIES RELATED TO THE PROCESS FOR 
THE REVIEW OF DEVICE APPLICATIONS. 
Subchapter A of chapter VII (21 U.S.C. 371 et seq.) 
is amended by inserting after section 713 the following 
new section: 
‘‘SEC. 714. STREAMLINED HIRING AUTHORITY. 
‘‘(a) IN GENERAL.—In addition to any other per-
sonnel authorities under other provisions of law, the Sec-
retary may, without regard to the provisions of title 5, 
United States Code, governing appointments in the com-
petitive service, appoint employees to positions in the Food 
and Drug Administration to perform, administer, or sup-
port activities described in subsection (b), if the Secretary 
determines that such appointments are needed to achieve 
the objectives specified in subsection (c). 
‘‘(b) ACTIVITIES DESCRIBED.—The activities de-
scribed in this subsection are activities under this Act re-
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lated to the process for the review of device applications 
(as defined in section 737(8)). 
‘‘(c) OBJECTIVES SPECIFIED.—The objectives speci-
fied in this subsection are with respect to the activities 
under subsection (b)(1), the goals referred to in section 
738A(a)(1). 
‘‘(d) INTERNAL CONTROLS.—The Secretary shall in-
stitute appropriate internal controls for appointments 
under this section. 
‘‘(e) SUNSET.—The authority to appoint employees 
under this section shall terminate on the date that is three 
years after the date of enactment of this section.’’. 
TITLE III—FEES RELATING TO 
GENERIC DRUGS 
SEC. 301. SHORT TITLE. 
(a) SHORT TITLE.—This title may be cited as the 
‘‘Generic Drug User Fee Amendments of 2012’’. 
(b) FINDING.—The Congress finds that the fees au-
thorized by the amendments made in this title will be dedi-
cated to human generic drug activities, as set forth in the 
goals identified for purposes of part 7 of subchapter C 
of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, in the letters from the Secretary of Health and 
Human Services to the Chairman of the Committee on 
Health, Education, Labor, and Pensions of the Senate and 
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the Chairman of the Committee on Energy and Commerce 
of the House of Representatives, as set forth in the Con-
gressional Record. 
SEC. 302. AUTHORITY TO ASSESS AND USE HUMAN GE-
NERIC DRUG FEES. 
Subchapter C of chapter VII (21 U.S.C. 379f et seq.) 
is amended by adding at the end the following: 
‘‘PART 7—FEES RELATING TO GENERIC DRUGS 
‘‘SEC. 744A. DEFINITIONS. 
‘‘For purposes of this part: 
‘‘(1) The term ‘abbreviated new drug applica-
tion’— 
‘‘(A) means an application submitted 
under section 505(j), an abbreviated application 
submitted under section 507 (as in effect on the 
day before the date of enactment of the Food 
and Drug Administration Modernization Act of 
1997), or an abbreviated new drug application 
submitted pursuant to regulations in effect 
prior to the implementation of the Drug Price 
Competition and Patent Term Restoration Act 
of 1984; and 
‘‘(B) does not include an application for a 
positron emission tomography drug. 
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‘‘(2) The term ‘active pharmaceutical ingre-
dient’ means— 
‘‘(A) a substance, or a mixture when the 
substance is unstable or cannot be transported 
on its own, intended— 
‘‘(i) to be used as a component of a 
drug; and 
‘‘(ii) to furnish pharmacological activ-
ity or other direct effect in the diagnosis, 
cure, mitigation, treatment, or prevention 
of disease, or to affect the structure or any 
function of the human body; or 
‘‘(B) a substance intended for final crys-
tallization, purification, or salt formation, or 
any combination of those activities, to become a 
substance or mixture described in subparagraph 
(A). 
‘‘(3) The term ‘adjustment factor’ means a fac-
tor applicable to a fiscal year that is the Consumer 
Price Index for all urban consumers (all items; 
United States city average) for October of the pre-
ceding fiscal year divided by such Index for October 
2011. 
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‘‘(4) The term ‘affiliate’ means a business enti-
ty that has a relationship with a second business en-
tity if, directly or indirectly— 
‘‘(A) one business entity controls, or has 
the power to control, the other business entity; 
or 
‘‘(B) a third party controls, or has power 
to control, both of the business entities. 
‘‘(5)(A) The term ‘facility’— 
‘‘(i) means a business or other entity— 
‘‘(I) under one management, either di-
rect or indirect; and 
‘‘(II) at one geographic location or ad-
dress engaged in manufacturing or proc-
essing an active pharmaceutical ingredient 
or a finished dosage form; and 
‘‘(ii) does not include a business or other 
entity whose only manufacturing or processing 
activities are one or more of the following: re-
packaging, relabeling, or testing. 
‘‘(B) For purposes of subparagraph (A), sepa-
rate buildings within close proximity are considered 
to be at one geographic location or address if the ac-
tivities in them are— 
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‘‘(i) closely related to the same business 
enterprise; 
‘‘(ii) under the supervision of the same 
local management; and 
‘‘(iii) capable of being inspected by the 
Food and Drug Administration during a single 
inspection. 
‘‘(C) If a business or other entity would meet 
the definition of a facility under this paragraph but 
for being under multiple management, the business 
or other entity is deemed to constitute multiple fa-
cilities, one per management entity, for purposes of 
this paragraph. 
‘‘(6) The term ‘finished dosage form’ means— 
‘‘(A) a drug product in the form in which 
it will be administered to a patient, such as a 
tablet, capsule, solution, or topical application; 
‘‘(B) a drug product in a form in which re-
constitution is necessary prior to administration 
to a patient, such as oral suspensions or 
lyophilized powders; or 
‘‘(C) any combination of an active pharma-
ceutical ingredient with another component of a 
drug product for purposes of production of a 
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drug product described in subparagraph (A) or 
(B). 
‘‘(7) The term ‘generic drug submission’ means 
an abbreviated new drug application, an amendment 
to an abbreviated new drug application, or a prior 
approval supplement to an abbreviated new drug ap-
plication. 
‘‘(8) The term ‘human generic drug activities’ 
means the following activities of the Secretary asso-
ciated with generic drugs and inspection of facilities 
associated with generic drugs: 
‘‘(A) The activities necessary for the re-
view of generic drug submissions, including re-
view of drug master files referenced in such 
submissions. 
‘‘(B) The issuance of— 
‘‘(i) approval letters which approve 
abbreviated new drug applications or sup-
plements to such applications; or 
‘‘(ii) complete response letters which 
set forth in detail the specific deficiencies 
in such applications and, where appro-
priate, the actions necessary to place such 
applications in condition for approval. 
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‘‘(C) The issuance of letters related to 
Type II active pharmaceutical drug master files 
which— 
‘‘(i) set forth in detail the specific de-
ficiencies in such submissions, and where 
appropriate, the actions necessary to re-
solve those deficiencies; or 
‘‘(ii) document that no deficiencies 
need to be addressed. 
‘‘(D) Inspections related to generic drugs. 
‘‘(E) Monitoring of research conducted in 
connection with the review of generic drug sub-
missions and drug master files. 
‘‘(F) Postmarket safety activities with re-
spect to drugs approved under abbreviated new 
drug applications or supplements, including the 
following activities: 
‘‘(i) Collecting, developing, and re-
viewing safety information on approved 
drugs, including adverse event reports. 
‘‘(ii) Developing and using improved 
adverse-event data-collection systems, in-
cluding information technology systems. 
‘‘(iii) Developing and using improved 
analytical tools to assess potential safety 
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problems, including access to external data 
bases. 
‘‘(iv) Implementing and enforcing sec-
tion 505(o) (relating to postapproval stud-
ies and clinical trials and labeling changes) 
and section 505(p) (relating to risk evalua-
tion and mitigation strategies) insofar as 
those activities relate to abbreviated new 
drug applications. 
‘‘(v) Carrying out section 505(k)(5) 
(relating to adverse-event reports and 
postmarket safety activities). 
‘‘(G) Regulatory science activities related 
to generic drugs. 
‘‘(9) The term ‘positron emission tomography 
drug’ has the meaning given to the term ‘com-
pounded positron emission tomography drug’ in sec-
tion 201(ii), except that paragraph (1)(B) of such 
section shall not apply. 
‘‘(10) The term ‘prior approval supplement’ 
means a request to the Secretary to approve a 
change in the drug substance, drug product, produc-
tion process, quality controls, equipment, or facilities 
covered by an approved abbreviated new drug appli-
cation when that change has a substantial potential 
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to have an adverse effect on the identity, strength, 
quality, purity, or potency of the drug product as 
these factors may relate to the safety or effective-
ness of the drug product. 
‘‘(11) The term ‘resources allocated for human 
generic drug activities’ means the expenses for— 
‘‘(A) officers and employees of the Food 
and Drug Administration, contractors of the 
Food and Drug Administration, advisory com-
mittees, and costs related to such officers and 
employees and to contracts with such contrac-
tors; 
‘‘(B) management of information, and the 
acquisition, maintenance, and repair of com-
puter resources; 
‘‘(C) leasing, maintenance, renovation, and 
repair of facilities and acquisition, maintenance, 
and repair of fixtures, furniture, scientific 
equipment, and other necessary materials and 
supplies; and 
‘‘(D) collecting fees under subsection (a) 
and accounting for resources allocated for the 
review of abbreviated new drug applications and 
supplements and inspection related to generic 
drugs. 
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‘‘(12) The term ‘Type II active pharmaceutical 
ingredient drug master file’ means a submission of 
information to the Secretary by a person that in-
tends to authorize the Food and Drug Administra-
tion to reference the information to support approval 
of a generic drug submission without the submitter 
having to disclose the information to the generic 
drug submission applicant. 
‘‘SEC. 744B. AUTHORITY TO ASSESS AND USE HUMAN GE-
NERIC DRUG FEES. 
‘‘(a) TYPES
OF FEES.—Beginning in fiscal year 
2013, the Secretary shall assess and collect fees in accord-
ance with this section as follows: 
‘‘(1) ONE-TIME
BACKLOG
FEE
FOR
ABBRE-
VIATED NEW DRUG APPLICATIONS PENDING ON OC-
TOBER 1, 2012.— 
‘‘(A) IN
GENERAL.—Each person that 
owns an abbreviated new drug application that 
is pending on October 1, 2012, and that has 
not received a tentative approval prior to that 
date, shall be subject to a fee for each such ap-
plication, as calculated under subparagraph 
(B). 
‘‘(B) METHOD OF FEE AMOUNT CALCULA-
TION.—The amount of each one-time backlog 
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fee shall be calculated by dividing $50,000,000 
by the total number of abbreviated new drug 
applications pending on October 1, 2012, that 
have not received a tentative approval as of that 
date. 
‘‘(C) NOTICE.—Not later than October 31, 
2012, the Secretary shall cause to be published 
in the Federal Register a notice announcing the 
amount of the fee required by subparagraph 
(A). 
‘‘(D) FEE DUE DATE.—The fee required 
by subparagraph (A) shall be due no later than 
30 calendar days after the date of the publica-
tion of the notice specified in subparagraph (C). 
‘‘(2) DRUG MASTER FILE FEE.— 
‘‘(A) IN
GENERAL.—Each person that 
owns a Type II active pharmaceutical ingre-
dient drug master file that is referenced on or 
after October 1, 2012, in a generic drug sub-
mission by any initial letter of authorization 
shall be subject to a drug master file fee. 
‘‘(B) ONE-TIME
PAYMENT.—If a person 
has paid a drug master file fee for a Type II 
active pharmaceutical ingredient drug master 
file, the person shall not be required to pay a 
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subsequent drug master file fee when that Type 
II active pharmaceutical ingredient drug master 
file is subsequently referenced in generic drug 
submissions. 
‘‘(C) NOTICE.— 
‘‘(i) FISCAL
YEAR
2013.—Not later 
than October 31, 2012, the Secretary shall 
cause to be published in the Federal Reg-
ister a notice announcing the amount of 
the drug master file fee for fiscal year 
2013. 
‘‘(ii) FISCAL
YEAR
2014
THROUGH 
2017.—Not later than 60 days before the 
start of each of fiscal years 2014 through 
2017, the Secretary shall cause to be pub-
lished in the Federal Register the amount 
of the drug master file fee established by 
this paragraph for such fiscal year. 
‘‘(D) AVAILABILITY FOR REFERENCE.— 
‘‘(i) IN
GENERAL.—Subject to sub-
section (g)(2)(C), for a generic drug sub-
mission to reference a Type II active phar-
maceutical ingredient drug master file, the 
drug master file must be deemed available 
for reference by the Secretary. 
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‘‘(ii) CONDITIONS.—A drug master 
file shall be deemed available for reference 
by the Secretary if— 
‘‘(I) the person that owns a Type 
II active pharmaceutical ingredient 
drug master file has paid the fee re-
quired under subparagraph (A) within 
20 calendar days after the applicable 
due date under subparagraph (E); 
and 
‘‘(II) the drug master file has not 
failed an initial completeness assess-
ment by the Secretary, in accordance 
with criteria to be published by the 
Secretary. 
‘‘(iii) 
LIST.—The 
Secretary 
shall 
make publicly available on the Internet 
Web site of the Food and Drug Adminis-
tration a list of the drug master file num-
bers that correspond to drug master files 
that have successfully undergone an initial 
completeness assessment, in accordance 
with criteria to be published by the Sec-
retary, and are available for reference. 
‘‘(E) FEE DUE DATE.— 
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‘‘(i) IN GENERAL.—Subject to clause 
(ii), a drug master file fee shall be due no 
later than the date on which the first ge-
neric drug submission is submitted that 
references the associated Type II active 
pharmaceutical ingredient drug master file. 
‘‘(ii) LIMITATION.—No fee shall be 
due under subparagraph (A) for a fiscal 
year until the later of— 
‘‘(I) 30 calendar days after publi-
cation of the notice provided for in 
clause (i) or (ii) of subparagraph (C), 
as applicable; or 
‘‘(II) 30 calendar days after the 
date of enactment of an appropria-
tions Act providing for the collection 
and obligation of fees under this sec-
tion. 
‘‘(3) ABBREVIATED
NEW
DRUG
APPLICATION 
AND PRIOR APPROVAL SUPPLEMENT FILING FEE.— 
‘‘(A) IN GENERAL.—Each applicant that 
submits, on or after October 1, 2012, an abbre-
viated new drug application or a prior approval 
supplement to an abbreviated new drug applica-
tion shall be subject to a fee for each such sub-
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mission in the amount established under sub-
section (d). 
‘‘(B) NOTICE.— 
‘‘(i) FISCAL
YEAR
2013.—Not later 
than October 31, 2012, the Secretary shall 
cause to be published in the Federal Reg-
ister a notice announcing the amount of 
the fees under subparagraph (A) for fiscal 
year 2013. 
‘‘(ii) FISCAL
YEARS
2014
THROUGH 
2017.—Not later than 60 days before the 
start of each of fiscal years 2014 through 
2017, the Secretary shall cause to be pub-
lished in the Federal Register the amount 
of the fees under subparagraph (A) for 
such fiscal year. 
‘‘(C) FEE DUE DATE.— 
‘‘(i) IN
GENERAL.—Except as pro-
vided in clause (ii), the fees required by 
subparagraphs (A) and (F) shall be due no 
later than the date of submission of the 
abbreviated new drug application or prior 
approval supplement for which such fee ap-
plies. 
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‘‘(ii) SPECIAL RULE FOR 2013.—For 
fiscal year 2013, such fees shall be due on 
the later of— 
‘‘(I) the date on which the fee is 
due under clause (i); 
‘‘(II) 30 calendar days after pub-
lication of the notice referred to in 
subparagraph (B)(i); or 
‘‘(III) if an appropriations Act is 
not enacted providing for the collec-
tion and obligation of fees under this 
section by the date of submission of 
the application or prior approval sup-
plement for which the fees under sub-
paragraphs (A) and (F) apply, 30 cal-
endar days after the date that such an 
appropriations Act is enacted. 
‘‘(D) REFUND OF FEE IF ABBREVIATED 
NEW DRUG APPLICATION IS NOT CONSIDERED 
TO
HAVE
BEEN
RECEIVED.—The Secretary 
shall refund 75 percent of the fee paid under 
subparagraph (A) for any abbreviated new drug 
application or prior approval supplement to an 
abbreviated new drug application that the Sec-
retary considers not to have been received with-
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in the meaning of section 505(j)(5)(A) for a 
cause other than failure to pay fees. 
‘‘(E) FEE FOR AN APPLICATION THE SEC-
RETARY CONSIDERS NOT TO HAVE BEEN RE-
CEIVED, OR THAT HAS BEEN WITHDRAWN.—An 
abbreviated new drug application or prior ap-
proval supplement that was submitted on or 
after October 1, 2012, and that the Secretary 
considers not to have been received, or that has 
been withdrawn, shall, upon resubmission of the 
application or a subsequent new submission fol-
lowing the applicant’s withdrawal of the appli-
cation, be subject to a full fee under subpara-
graph (A). 
‘‘(F) ADDITIONAL FEE FOR ACTIVE PHAR-
MACEUTICAL
INGREDIENT
INFORMATION
NOT 
INCLUDED BY REFERENCE TO TYPE II ACTIVE 
PHARMACEUTICAL INGREDIENT DRUG MASTER 
FILE.—An applicant that submits a generic 
drug submission on or after October 1, 2012, 
shall pay a fee, in the amount determined under 
subsection (d)(3), in addition to the fee re-
quired under subparagraph (A), if— 
‘‘(i) such submission contains infor-
mation concerning the manufacture of an 
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active pharmaceutical ingredient at a facil-
ity by means other than reference by a let-
ter of authorization to a Type II active 
pharmaceutical drug master file; and 
‘‘(ii) a fee in the amount equal to the 
drug master file fee established in para-
graph (2) has not been previously paid 
with respect to such information. 
‘‘(4) GENERIC DRUG FACILITY FEE AND ACTIVE 
PHARMACEUTICAL INGREDIENT FACILITY FEE.— 
‘‘(A) IN
GENERAL.—Facilities identified, 
or intended to be identified, in at least one ge-
neric drug submission that is pending or ap-
proved to produce a finished dosage form of a 
human generic drug or an active pharma-
ceutical ingredient contained in a human ge-
neric drug shall be subject to fees as follows: 
‘‘(i) GENERIC DRUG FACILITY.—Each 
person that owns a facility which is identi-
fied or intended to be identified in at least 
one generic drug submission that is pend-
ing or approved to produce one or more 
finished dosage forms of a human generic 
drug shall be assessed an annual fee for 
each such facility. 
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‘‘(ii) ACTIVE
PHARMACEUTICAL
IN-
GREDIENT
FACILITY.—Each person that 
owns a facility which produces, or which is 
pending review to produce, one or more ac-
tive pharmaceutical ingredients identified, 
or intended to be identified, in at least one 
generic drug submission that is pending or 
approved or in a Type II active pharma-
ceutical ingredient drug master file ref-
erenced in such a generic drug submission, 
shall be assessed an annual fee for each 
such facility. 
‘‘(iii) FACILITIES
PRODUCING
BOTH 
ACTIVE
PHARMACEUTICAL
INGREDIENTS 
AND
FINISHED
DOSAGE
FORMS.—Each 
person that owns a facility identified, or 
intended to be identified, in at least one 
generic drug submission that is pending or 
approved to produce both one or more fin-
ished dosage forms subject to clause (i) 
and one or more active pharmaceutical in-
gredients subject to clause (ii) shall be 
subject to fees under both such clauses for 
that facility. 
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‘‘(B) AMOUNT.—The amount of fees estab-
lished under subparagraph (A) shall be estab-
lished under subsection (d). 
‘‘(C) NOTICE.— 
‘‘(i) FISCAL
YEAR
2013.—For fiscal 
year 2013, the Secretary shall cause to be 
published in the Federal Register a notice 
announcing the amount of the fees pro-
vided for in subparagraph (A) within the 
timeframe 
specified 
in 
subsection 
(d)(1)(B). 
‘‘(ii) FISCAL
YEARS
2014
THROUGH 
2017.—Within the timeframe specified in 
subsection (d)(2), the Secretary shall cause 
to be published in the Federal Register the 
amount of the fees under subparagraph 
(A) for such fiscal year. 
‘‘(D) FEE DUE DATE.— 
‘‘(i) FISCAL
YEAR
2013.—For fiscal 
year 2013, the fees under subparagraph 
(A) shall be due on the later of— 
‘‘(I) not later than 45 days after 
the publication of the notice under 
subparagraph (B); or 
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‘‘(II) if an appropriations Act is 
not enacted providing for the collec-
tion and obligation of fees under this 
section by the date of the publication 
of such notice, 30 days after the date 
that such an appropriations Act is en-
acted. 
‘‘(ii) FISCAL
YEARS
2014
THROUGH 
2017.—For each of fiscal years 2014 
through 2017, the fees under subpara-
graph (A) for such fiscal year shall be due 
on the later of— 
‘‘(I) the first business day on or 
after October 1 of each such year; or 
‘‘(II) the first business day after 
the enactment of an appropriations 
Act providing for the collection and 
obligation of fees under this section 
for such year. 
‘‘(5) DATE OF SUBMISSION.—For purposes of 
this part, a generic drug submission or Type II 
pharmaceutical master file is deemed to be ‘sub-
mitted’ to the Food and Drug Administration— 
‘‘(A) if it is submitted via a Food and 
Drug Administration electronic gateway, on the 
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day when transmission to that electronic gate-
way is completed, except that a submission or 
master file that arrives on a weekend, Federal 
holiday, or day when the Food and Drug Ad-
ministration office that will review that submis-
sion is not otherwise open for business shall be 
deemed to be submitted on the next day when 
that office is open for business; and 
‘‘(B) if it is submitted in physical media 
form, on the day it arrives at the appropriate 
designated document room of the Food and 
Drug Administration. 
‘‘(b) FEE REVENUE AMOUNTS.— 
‘‘(1) IN GENERAL.— 
‘‘(A) FISCAL YEAR 2013.—For fiscal year 
2013, fees under subsection (a) shall be estab-
lished to generate a total estimated revenue 
amount under such subsection of $299,000,000. 
Of that amount— 
‘‘(i) $50,000,000 shall be generated 
by the one-time backlog fee for generic 
drug applications pending on October 1, 
2012, established in subsection (a)(1); and 
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‘‘(ii) $249,000,000 shall be generated 
by the fees under paragraphs (2) through 
(4) of subsection (a). 
‘‘(B) FISCAL YEARS 2014 THROUGH 2017.— 
For each of the fiscal years 2014 through 2017, 
fees under paragraphs (2) through (4) of sub-
section (a) shall be established to generate a 
total estimated revenue amount under such sub-
section that is equal to $299,000,000, as ad-
justed pursuant to subsection (c). 
‘‘(2) TYPES
OF
FEES.—In establishing fees 
under paragraph (1) to generate the revenue 
amounts specified in paragraph (1)(A)(ii) for fiscal 
year 2013 and paragraph (1)(B) for each of fiscal 
years 2014 through 2017, such fees shall be derived 
from the fees under paragraphs (2) through (4) of 
subsection (a) as follows: 
‘‘(A) 6 percent shall be derived from fees 
under subsection (a)(2) (relating to drug mas-
ter files). 
‘‘(B) 24 percent shall be derived from fees 
under subsection (a)(3) (relating to abbreviated 
new drug applications and supplements). The 
amount of a fee for a prior approval supplement 
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shall be half the amount of the fee for an ab-
breviated new drug application. 
‘‘(C) 56 percent shall be derived from fees 
under subsection (a)(4)(A)(i) (relating to ge-
neric drug facilities). The amount of the fee for 
a facility located outside the United States and 
its territories and possessions shall be not less 
than $15,000 and not more than $30,000 high-
er than the amount of the fee for a facility lo-
cated in the United States and its territories 
and possessions, as determined by the Secretary 
on the basis of data concerning the difference 
in cost between inspections of facilities located 
in the United States, including its territories 
and possessions, and those located outside of 
the United States and its territories and posses-
sions. 
‘‘(D) 14 percent shall be derived from fees 
under subsection (a)(4)(A)(ii) (relating to active 
pharmaceutical 
ingredient 
facilities). 
The 
amount of the fee for a facility located outside 
the United States and its territories and posses-
sions shall be not less than $15,000 and not 
more than $30,000 higher than the amount of 
the fee for a facility located in the United 
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States, including its territories and possessions, 
as determined by the Secretary on the basis of 
data concerning the difference in cost between 
inspections of facilities located in the United 
States and its territories and possessions and 
those located outside of the United States and 
its territories and possessions. 
‘‘(c) ADJUSTMENTS.— 
‘‘(1) INFLATION ADJUSTMENT.—For fiscal year 
2014 and subsequent fiscal years, the revenues es-
tablished in subsection (b) shall be adjusted by the 
Secretary by notice, published in the Federal Reg-
ister, for a fiscal year, by an amount equal to the 
sum of— 
‘‘(A) one; 
‘‘(B) the average annual percent change in 
the cost, per full-time equivalent position of the 
Food and Drug Administration, of all personnel 
compensation and benefits paid with respect to 
such positions for the first 3 years of the pre-
ceding 4 fiscal years multiplied by the propor-
tion of personnel compensation and benefits 
costs to total costs of human generic drug ac-
tivities for the first 3 years of the preceding 4 
fiscal years; and 
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‘‘(C) the average annual percent change 
that occurred in the Consumer Price Index for 
urban consumers (Washington-Baltimore, DC– 
MD–VA–WV; Not Seasonally Adjusted; All 
items; Annual Index) for the first 3 years of the 
preceding 4 years of available data multiplied 
by the proportion of all costs other than per-
sonnel compensation and benefits costs to total 
costs of human generic drug activities for the 
first 3 years of the preceding 4 fiscal years. 
The adjustment made each fiscal year under this 
subsection shall be added on a compounded basis to 
the sum of all adjustments made each fiscal year 
after fiscal year 2013 under this subsection. 
‘‘(2) FINAL
YEAR
ADJUSTMENT.—For fiscal 
year 2017, the Secretary may, in addition to adjust-
ments under paragraph (1), further increase the fee 
revenues and fees established in subsection (b) if 
such an adjustment is necessary to provide for not 
more than 3 months of operating reserves of carry-
over user fees for human generic drug activities for 
the first 3 months of fiscal year 2018. Such fees 
may only be used in fiscal year 2018. If such an ad-
justment is necessary, the rationale for the amount 
of the increase shall be contained in the annual no-
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tice establishing fee revenues and fees for fiscal year 
2017. If the Secretary has carryover balances for 
such activities in excess of 3 months of such oper-
ating reserves, the adjustment under this subpara-
graph shall not be made. 
‘‘(d) ANNUAL FEE SETTING.— 
‘‘(1) FISCAL
YEAR
2013.—For fiscal year 
2013— 
‘‘(A) the Secretary shall establish, by Octo-
ber 31, 2012, the one-time generic drug backlog 
fee for generic drug applications pending on Oc-
tober 1, 2012, the drug master file fee, the ab-
breviated new drug application fee, and the 
prior approval supplement fee under subsection 
(a), based on the revenue amounts established 
under subsection (b); and 
‘‘(B) the Secretary shall establish, not 
later than 45 days after the date to comply 
with the requirement for identification of facili-
ties in subsection (f)(2), the generic drug facil-
ity fee and active pharmaceutical ingredient fa-
cility fee under subsection (a) based on the rev-
enue amounts established under subsection (b). 
‘‘(2) FISCAL YEARS 2014 THROUGH 2017.—Not 
more than 60 days before the first day of each of 
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‘‘(ii) If such fee is not paid within 20 cal-
endar days of the Secretary providing the noti-
fication, the abbreviated new drug application 
or supplement to an abbreviated new drug ap-
plication shall not be received within the mean-
ing of 505(j)(5)(A). 
‘‘(3) ABBREVIATED
NEW
DRUG
APPLICATION 
FEE
AND
PRIOR
APPROVAL
SUPPLEMENT
FEE.— 
Failure to pay a fee under subparagraph (A) or (F) 
of subsection (a)(3) within 20 calendar days of the 
applicable due date under subparagraph (C) of such 
subsection shall result in the abbreviated new drug 
application or the prior approval supplement to an 
abbreviated new drug application not being received 
within the meaning of section 505(j)(5)(A) until 
such outstanding fee is paid. 
‘‘(4) GENERIC DRUG FACILITY FEE AND ACTIVE 
PHARMACEUTICAL INGREDIENT FACILITY FEE.— 
‘‘(A) IN GENERAL.—Failure to pay the fee 
under subsection (a)(4) within 20 calendar days 
of the due date as specified in subparagraph 
(D) of such subsection shall result in the fol-
lowing: 
‘‘(i) The Secretary shall place the fa-
cility on a publicly available arrears list, 
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‘‘(II) Not later than 5 days after 
the Secretary grants a request for a 
biosimilar biological product develop-
ment meeting. 
‘‘(B) ANNUAL
BIOSIMILAR
BIOLOGICAL 
PRODUCT DEVELOPMENT FEE.— 
‘‘(i) IN
GENERAL.—A person that 
pays an initial biosimilar biological product 
development fee for a product shall pay for 
such product, beginning in the fiscal year 
following the fiscal year in which the initial 
biosimilar biological product development 
fee was paid, an annual fee established 
under subsection (b)(1)(B) for biosimilar 
biological product development (referred to 
in this section as ‘annual biosimilar bio-
logical product development fee’). 
‘‘(ii) DUE
DATE.—The annual bio-
similar biological product development pro-
gram fee for each fiscal year will be due on 
the later of— 
‘‘(I) the first business day on or 
after October 1 of each such year; or 
‘‘(II) the first business day after 
the enactment of an appropriations 
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