[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6433 Received in Senate (RDS)]

112th CONGRESS
  2d Session
                                H. R. 6433


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 20, 2012

                                Received

_______________________________________________________________________

                                 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 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.

            Passed the House of Representatives September 19, 2012.

            Attest:

                                                 KAREN L. HAAS,

                                                                 Clerk.