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
H. R. 6433
AN ACT
To make corrections with respect to Food and Drug Administration user fees.
Short title
This Act may be cited as the FDA User Fee Corrections Act of 2012
.
Corrections to FDA user fees
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)
.
Subchapter C of title VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f et seq.) is amended—
in section 738(i)(2)(A)(ii), by striking shall only be available
and inserting shall be available
;
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
in section 744B(i)(2)(C)—
by inserting a comma after September 30, 2013
; and
by striking the comma after for fiscal year 2013
.
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.
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—
the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies; or
30 calendar days after publication of the notice referred to in section 744B(a)(3)(B)(i) of such Act.
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.