II 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.

1.

Short title

This Act may be cited as the FDA User Fee Corrections Act of 2012.

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. Karen L. Haas, Clerk