Page:United States Statutes at Large Volume 111 Part 3.djvu/238

 Ill STAT. 2326 PUBLIC LAW 105-115—NOV. 21, 1997 (G) Section 525(a) (21 U.S.C. 360aa(a)) is amended by striking ", certification of such drug for such disease or condition under section 507,", (H) Section 526(a)(1) (21 U.S.C. 360bb) is amended by striking "the submission of an application for certification of the drug under section 507,", by inserting "or" at the end of subparagraph (A), by striking subparagraph (B), and by redesignating subparagraph (C) as subparagraph (B), (I) Section 526(b) (21 U.S.C. 360bb(b)) is amended— (i) in paragraph (1), by striking ", a certificate was issued for the drug under section 507,"; and (ii) in paragraph (2) by striking ", a certificate has not been issued for the drug under section 507," and by striking ", approval of an application for certification under section 507,". (J) Section 527(a) (21 U.S.C. 360cc(a)) is amended by inserting "or" at the end of paragraph (1), by striking paragraph (2), by redesignating paragraph (3) as paragraph (2), and by striking ", issue another certification under section 507,". (K) Section 527(b) (21 U.S.C. 360cc(b)) is amended by striking ", if a certification is issued under section 507 for such a drug,", ", of the issuance of the certification under section 507,", ", issue another certification under section 507,", ", of such certification,", ", of the certification,", and ", issuance of other certifications,". (L) Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended by striking ", section 507(d) or (g),". (M) Section 735(1) (21 U.S.C. 379g(l)(C)) is amended by inserting "or" at the end of subparagraph (B), by striking subparagraph (C), and by redesignating subparagraph (D) as subparagraph (C). (N) Subparagraphs (A)(ii) and (B) of sections 5(b)(1) of the Orphan Drug Act (21 U.S.C. 360ee(b)(l)(A), 360ee(b)(l)(B)) are each amended by striking "or 507". (O) Section 45C(b)(2)(A)(ii)(II) of the Internal Revenue 26 USC 45C. Code of 1986 is amended by striking "or 507". (P) Section 156(f)(4)(B) of title 35, United States Code, is amended by striking "507," each place it occurs, (c) EXPORTATION.— Section 802 (21 U.S.C. 382) is amended by adding at the end the following: "(i) Insulin and antibiotic drugs may be exported without regard to the requirements in this section if the insulin and antibiotic drugs meet the requirements of section 801(e)(1).". 21 USC 355 note. (d) TRANSITION.— (1) IN GENERAL. —An application that was approved by the Secretary of Health and Human Services before the date of the enactment of this Act for the marketing of an antibiotic drug under section 507 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 357), as in effect on the day before the date of the enactment of this Act, shall, on and after such date of enactment, be considered to be an application that was submitted and filed under section 505(b) of such Act (21 U.S.C. 355(b)) and approved for safety and effectiveness under section

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