I 
112TH CONGRESS 
2D SESSION 
H. R. 3988 
To amend the Federal Food, Drug, and Cosmetic Act to establish user- 
fee 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 Com-
mittee 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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
This Act may be cited as the ‘‘Generic Drug and Bio-
similar User Fee Act of 2012’’. 
SEC. 2. TABLE OF CONTENTS. 
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. 
TITLE I—FEES RELATING TO 
GENERIC DRUGS 
SEC. 101. SHORT TITLE; REFERENCES IN TITLE; FINDINGS. 
(a) SHORT TITLE.—This title may be cited as the 
‘‘Generic Drug User Fee Amendments of 2012’’. 
(b) REFERENCES IN ACT.—Except as otherwise spec-
ified, amendments made by this title to a section or other 
provision of law are amendments to such section or other 
provision of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301 et seq.). 
(c) FINDINGS.—The Congress finds that the fees au-
thorized by the amendments made in this title will be dedi-
cated, as set forth in the goals identified 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 the Chairman of the Com-
mittee on Energy and Commerce of the House of Rep-
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resentatives, as set forth in the Congressional Record. 
These fees are intended to help the Food and Drug Ad-
ministration ensure that participants in the United States 
generic drug system comply with United States quality 
standards, and to increase the likelihood that American 
consumers have timely access to low-cost, high-quality ge-
neric drugs. A comprehensive human generic drug user fee 
program, to be supplemental to traditional appropriated 
funding, should be focused on three key aims: 
(1) SAFETY.—Ensure that industry partici-
pants, foreign or domestic, who participate in the 
United States generic drug system are held to con-
sistent high-quality standards and are inspected bi-
ennially, using a risk-based approach, with foreign 
and domestic parity. 
(2) ACCESS.—Expedite the availability of low- 
cost, high-quality generic drugs by bringing greater 
predictability to the review times for abbreviated 
new drug applications, amendments, and supple-
ments, increasing predictability and timeliness in the 
review process. 
(3) TRANSPARENCY.—Enhance the Food and 
Drug Administration’s ability to protect Americans 
in the complex global supply environment by requir-
ing the identification of facilities involved in the 
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manufacture of generic drugs and associated active 
pharmaceutical ingredients, and improving the Food 
and Drug Administration’s communications and 
feedback with industry in order to expedite product 
access. 
SEC. 102. 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 
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‘‘(B) does not include an application for a 
positron emission tomography drug. 
‘‘(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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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 available on the public Internet Web 
site of the Food and Drug Administration 
a list of the drug master file numbers that 
correspond to drug master files that have 
successfully undergone an initial complete-
ness assessment, in accordance with cri-
teria to be published by the Secretary, and 
are available for reference. 
‘‘(E) FEE DUE DATE.— 
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‘‘(i) IN GENERAL.—Subject to clauses 
(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 when 
it arrives in the appropriate electronic portal of the 
Food and Drug Administration or, if in paper form, 
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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 
‘‘(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 
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amounts specified in paragraph (1)(A)(ii) for fiscal 
year 2013 and (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 
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 
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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 
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-
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ister, for a fiscal year, by an amount equal to the 
sum of— 
‘‘(A) one; 
‘‘(B) the average annual 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 
‘‘(C) the average annual change that oc-
curred 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 pre-
ceding 4 years of available data multiplied by 
the proportion of all costs other than personnel 
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 
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