Page:United States Statutes at Large Volume 122.djvu/4099

 12 2 STA T .4076PUBLIC LA W 110 –3 7 9—O CT. 8, 2008 plansh all n otber e g ar d ed as f a i ling to c o m pl yw ith the re qu ire - ments of such title solely on the basis of its failure to meet these additional requirements before the first day of the first calendar quarter beginning after the close of the first regular session of the S tate legislature that begins after the date of enactment of this A ct .F or purposes of the pre v ious sentence , in the case of a State that has a 2 -year legislative session, each year of the session is considered to be a separate regular session of the State legislature. SEC.4 . IN CEN T I V ES FOR T H E D EVE L O PM ENT OF ,A ND ACCESS TO, CERTAIN ANTI B IOTICS. ( a )INGE NE RAL . — Section 50 5 of the Federal Food, D rug, and C osmetic Act (2 1U .S.C. 3 55) is amended by adding at the end the following

‘(v) AN TIB I O TI C DR UGS SUB M ITTE DB E F ORE N O V EMBER 21, 1 9 9 7 .— ‘‘(1) ANTIBIOTIC DRUGS A P PROVED BEFORE NOVEMBER 21, 1 9 9 7 .— ‘‘(A) IN GENERAL.—Notwithstanding any provision of the Food and Drug Administration M oderni z ation Act of 1997 or any other provision of law, a sponsor of a drug that is the sub j ect of an application described in subpara- graph (B)(i) shall be eligible for, with respect to the drug, the 3-year e x clusivity period referred to under clauses (iii) and (iv) of subsection (c)(3)( E ) and under clauses (iii) and (iv) of subsection (j)(5)(F), subject to the requirements of such clauses, as applicable. ‘‘(B) APPLICATION ANTIBIOTIC DRUG DESCRIBED.— ‘‘(i) APPLICATION.—An application described in this clause is an application for mar k eting submitted under this section after the date of the enactment of this subsection in which the drug that is the subject of the application contains an antibiotic drug described in clause (ii). ‘‘(ii) ANTIBIOTIC DRUG.—An antibiotic drug described in this clause is an antibiotic drug that was the subject of an application approved by the Secretary under section 507 of this Act (as in effect before November 21, 1997). ‘‘(2) ANTIBIOTIC DRUGS SUBMITTED BEFORE NOVEMBER 21, 1997, BUT NOT APPROVED.— ‘‘(A) IN GENERAL.—Notwithstanding any provision of the Food and Drug Administration Modernization Act of 1997 or any other provision of law, a sponsor of a drug that is the subject of an application described in subpara- graph (B)(i) may elect to be eligible for, with respect to the drug— ‘‘(i)(I) the 3-year exclusivity period referred to under clauses (iii) and (iv) of subsection (c)(3)(E) and under clauses (iii) and (iv) of subsection (j)(5)(F), sub- ject to the requirements of such clauses, as applicable; and ‘‘(II) the 5-year exclusivity period referred to under clause (ii) of subsection (c)(3)(E) and under clause (ii) of subsection (j)(5)(F), subject to the requirements of such clauses, as applicable; or

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