121 STAT. 976
PUBLIC LAW 110–85—SEPT. 27, 2007
information is reasonably available) and periodically update clinically susceptible concentrations. (c) PUBLIC AVAILABILITY.—The Secretary, through the Commissioner of Food and Drugs, shall make such clinically susceptible concentrations publicly available, such as by posting on the Internet, not later than 30 days after the date of identification and any update under this section. (d) EFFECT.—Nothing in this section shall be construed to restrict, in any manner, the prescribing of antibiotics by physicians, or to limit the practice of medicine, including for diseases such as Lyme and tick-borne diseases.
Deadline.
SEC. 1112. ORPHAN ANTIBIOTIC DRUGS.
Appropriation authorization.
(a) PUBLIC MEETING.—The Commissioner of Food and Drugs shall convene a public meeting regarding which serious and life threatening infectious diseases, such as diseases due to gram-negative bacteria and other diseases due to antibiotic-resistant bacteria, potentially qualify for available grants and contracts under section 5(a) of the Orphan Drug Act (21 U.S.C. 360ee(a)) or other incentives for development. (b) GRANTS AND CONTRACTS FOR THE DEVELOPMENT OF ORPHAN DRUGS.—Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended to read as follows: ‘‘(c) For grants and contracts under subsection (a), there is authorized to be appropriated $30,000,000 for each of fiscal years 2008 through 2012.’’. SEC. 1113. EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.
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Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by section 920, is further amended by adding at the end the following: ‘‘(u) CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.— ‘‘(1) IN GENERAL.—For purposes of subsections (c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is submitted under subsection (b) for a non-racemic drug containing as an active ingredient (including any ester or salt of the active ingredient) a single enantiomer that is contained in a racemic drug approved in another application under subsection (b), the applicant may, in the application for such non-racemic drug, elect to have the single enantiomer not be considered the same active ingredient as that contained in the approved racemic drug, if— ‘‘(A)(i) the single enantiomer has not been previously approved except in the approved racemic drug; and ‘‘(ii) the application submitted under subsection (b) for such non-racemic drug— ‘‘(I) includes full reports of new clinical investigations (other than bioavailability studies)— ‘‘(aa) necessary for the approval of the application under subsections (c) and (d); and ‘‘(bb) conducted or sponsored by the applicant; and ‘‘(II) does not rely on any investigations that are part of an application submitted under subsection (b) for approval of the approved racemic drug; and ‘‘(B) the application submitted under subsection (b) for such non-racemic drug is not submitted for approval of a condition of use—
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