FDA User Fee Corrections Act of 2012 Public Law 112–193 FDA User Fee Corrections Act of 2012 193 112–193 Statute Compilation United States House of Representatives Office of the Legislative Counsel text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. GPO Statute Compilations USLM converter, version 20210527.1 2021-10-15 FDA User Fee Corrections Act of 2012 10002 112 2012-10-05 FDA User Fee Corrections Act of 2012 [(Public Law 112–193)] [This law has not been amended] [Currency: This publication is a compilation of the text of Public Law 112-193. It was last amended by the public law listed in the As Amended Through note above and below at the bottom of each page of the pdf version and reflects current law through the date of the enactment of the public law listed at https://www.govinfo.gov/app/collection/comps/] [Note: While this publication does not represent an official version of any Federal statute, substantial efforts have been made to ensure the accuracy of its contents. The official version of Federal law is found in the United States Statutes at Large and in the United States Code. The legal effect to be given to the Statutes at Large and the United States Code is established by statute (1 U.S.C. 112, 204).]
AN ACTTo 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) [21 U.S.C. 379j] in section 738(i)(2)(A)(ii), by striking “shall only be available” and inserting “shall be available”; (2) [21 U.S.C. 379j-42] 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) [21 U.S.C. 379j-42 note] 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.