[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6433 Enrolled Bill (ENR)]

        H.R.6433

                      One Hundred Twelfth Congress

                                 of the

                        United States of America


                          AT THE SECOND SESSION

          Begun and held at the City of Washington on Tuesday,
            the third day of January, two thousand and twelve


                                 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.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.