[Congressional Record Volume 158, Number 127 (Wednesday, September 19, 2012)]
[House]
[Pages H6137-H6138]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                              {time}  2050
                  FDA USER FEE CORRECTIONS ACT OF 2012

  Mr. UPTON. Mr. Speaker, I ask unanimous consent that the Committee on 
Energy and Commerce be discharged from further consideration of the 
bill (H.R. 6433) to make corrections with respect to Food and Drug 
Administration user fees, and ask for its immediate consideration in 
the House.
  The Clerk read the title of the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Michigan?
  There was no objection.
  The text of the bill is as follows:

                               H.R. 6433

       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

[[Page H6138]]

     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.

  The bill was ordered to be engrossed and read a third time, was read 
the third time, and passed, and a motion to reconsider was laid on the 
table.


                             General Leave

  Mr. UPTON. Mr. Speaker, I ask unanimous consent that all Members may 
have 5 legislative days in which to revise and extend their remarks and 
insert extraneous materials in the Record on this bill, H.R. 6433.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Michigan?
  There was no objection.

                          ____________________