[United States Statutes at Large, Volume 126, 112th Congress, 2nd Session]
[From the U.S. Government Publishing Office, www.gpo.gov]


Public Law 112-193
112th Congress

An Act


 
To make corrections with respect to Food and Drug Administration user
fees. <>

Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <>
SECTION 1. SHORT TITLE.

This Act may be cited as the ``FDA User Fee Corrections Act of
2012''.
SEC. 2. CORRECTIONS TO FDA USER FEES.

(a) Section 502(aa) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 352(aa)) is amended by striking ``744A(a)(4)'' and inserting
``744B(a)(4)''.
(b) Subchapter C of title VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379f et seq.) is amended--
(1) in section 738(i)(2)(A)(ii), <> by
striking ``shall only be available'' and inserting ``shall be
available'';
(2) in sections 744B(a)(2)(E)(ii)(II),
744B(a)(3)(C)(ii)(III), 744B(a)(4)(D)(i)(II), and
744B(a)(4)(D)(ii)(II), <> by inserting
``for such year'' after ``obligation of fees'' each place it
appears; and
(3) in section 744B(i)(2)(C)--
(A) by inserting a comma after ``September 30,
2013''; and
(B) by striking the comma after ``for fiscal year
2013''.

(c)(1) <> Notwithstanding
section 744B(a)(2)(E)(ii) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-42(a)(2)(E)(ii)), the fee authorized under section
744B(a)(2) of such Act for fiscal year 2013 shall be due 30 calendar
days after publication of the notice provided for in section
744B(a)(2)(C)(i) of such Act.

(2) Notwithstanding section 744B(a)(3)(C)(ii) of such Act, the fee
authorized under section 744B(a)(3) of such Act for fiscal year 2013
shall be due on the later of--
(A) the date of submission of the abbreviated new drug
application or prior approval supplement for which such fee
applies; or
(B) 30 calendar days after publication of the notice
referred to in section 744B(a)(3)(B)(i) of such Act.

(3) Notwithstanding section 744B(a)(4)(D)(i) of such Act, the fee
authorized under section 744B(a)(4) of such Act for fiscal year

[[Page 1444]]

2013 shall be due not later than 45 days after the publication of the
notice under section 744B(a)(4)(C)(i) of such Act.

Approved October 5, 2012.

LEGISLATIVE HISTORY--H.R. 6433:
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CONGRESSIONAL RECORD, Vol. 158 (2012):
Sept. 19, considered and passed House.
Sept. 21, considered and passed Senate.