spect to section 744A (regarding assessment and use of 
human generic drug fees), as set forth in the letters de-
scribed in section 101(c) of the Generic Drug User Fee 
Amendments of 2012. 
‘‘(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 II—FEES RELATING TO 
BIOSIMILAR 
BIOLOGICAL 
PRODUCTS 
SEC. 201. SHORT TITLE; REFERENCES IN TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the 
‘‘Biosimilar User Fee Act 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) FINDING.—The Congress finds that the fees au-
thorized by the amendments made in this title will be dedi-
cated to expediting the process for the review of biosimilar 
biological product applications, including postmarket safe-
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ty activities, as set forth in the goals identified for pur-
poses of part 8 of subchapter C of chapter VII of the Fed-
eral 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. FEES RELATING TO BIOSIMILAR BIOLOGICAL 
PRODUCTS. 
Subchapter C of chapter VII (21 U.S.C. 379f et seq.) 
is amended by inserting after part 7, as added by title 
I of this Act, the following: 
‘‘PART 8—FEES RELATING TO BIOSIMILAR 
BIOLOGICAL PRODUCTS 
‘‘SEC. 744G. DEFINITIONS. 
‘‘For purposes of this part: 
‘‘(1) The term ‘adjustment factor’ applicable to 
a fiscal year that is the Consumer Price Index for 
all urban consumers (Washington-Baltimore, DC– 
MD–VA–WV; Not Seasonally Adjusted; All items) of 
the preceding fiscal year divided by such Index for 
September 2011. 
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‘‘(2) 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. 
‘‘(3) The term ‘biosimilar biological product’ 
means a product for which a biosimilar biological 
product application has been approved. 
‘‘(4)(A) Subject to subparagraph (B), the term 
‘biosimilar biological product application’ means an 
application for licensure of a biological product 
under section 351(k) of the Public Health Service 
Act. 
‘‘(B) Such term does not include— 
‘‘(i) a supplement to such an application; 
‘‘(ii) an application filed under section 
351(k) of the Public Health Service Act that 
cites as the reference product a bovine blood 
product for topical application licensed before 
September 1, 1992, or a large volume paren-
teral drug product approved before such date; 
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‘‘(iii) an application filed under section 
351(k) of the Public Health Service Act with 
respect to— 
‘‘(I) whole blood or a blood component 
for transfusion; 
‘‘(II) an allergenic extract product; 
‘‘(III) an in vitro diagnostic biological 
product; or 
‘‘(IV) a biological product for further 
manufacturing use only; or 
‘‘(iv) an application for licensure under 
section 351(k) of the Public Health Service Act 
that is submitted by a State or Federal Govern-
ment entity for a product that is not distributed 
commercially. 
‘‘(5) The term ‘biosimilar biological product de-
velopment meeting’ means any meeting, other than 
a biosimilar initial advisory meeting, regarding the 
content of a development program, including a pro-
posed design for, or data from, a study intended to 
support a biosimilar biological product application. 
‘‘(6) The term ‘biosimilar biological product de-
velopment program’ means the program under this 
part for expediting the process for the review of sub-
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missions in connection with biosimilar biological 
product development. 
‘‘(7)(A) The term ‘biosimilar biological product 
establishment’ means a foreign or domestic place of 
business— 
‘‘(i) that is at one general physical location 
consisting of one or more buildings, all of which 
are within five miles of each other; and 
‘‘(ii) at which one or more biosimilar bio-
logical products are manufactured in final dos-
age form. 
‘‘(B) For purposes of subparagraph (A)(ii), the 
term ‘manufactured’ does not include packaging. 
‘‘(8) The term ‘biosimilar initial advisory meet-
ing’— 
‘‘(A) means a meeting, if requested, that is 
limited to— 
‘‘(i) a general discussion regarding 
whether licensure under section 351(k) of 
the Public Health Service Act may be fea-
sible for a particular product; and 
‘‘(ii) if so, general advice on the ex-
pected content of the development pro-
gram; and 
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‘‘(B) does not include any meeting that in-
volves substantive review of summary data or 
full study reports. 
‘‘(9) The term ‘costs of resources allocated for 
the process for the review of biosimilar biological 
product applications’ means the expenses in connec-
tion with the process for the review of biosimilar bio-
logical product applications 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 em-
ployees and committees and to contracts with 
such contractors; 
‘‘(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 section 744H 
and accounting for resources allocated for the 
review of submissions in connection with bio-
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