Sec. 3. Susceptibility test interpretive criteria for microbial organisms
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Section 511 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360a ) is amended to read as follows: The Secretary shall identify upon approval and subsequently update susceptibility test interpretive criteria for antibacterial drugs (including biological products intended to treat a bacterial infection and other types of antimicrobial drugs, as deemed appropriate by the Secretary), including qualified infectious disease products, by relying upon, to the extent available— preclinical and clinical data, including pharmacokinetic, pharmacodynamic, and epidemiological data;
Bayesian and pharmacometric statistical methodologies; and such other confirmatory evidence as the Secretary deems necessary. Each quarter of each fiscal year, the Secretary shall— evaluate any appropriate new or updated susceptibility test interpretive criteria published by a nationally or internationally recognized standard development organization; and publish on the public Website of the Food and Drug Administration a notice— adopting the new or updated interpretive criteria; declining to adopt the new or updated interpretive criteria and explaining the reason for such decision; or adopting one or more parts of the new or updated interpretive criteria, declining to adopt the remainder of such criteria, and explaining the reason for so declining.
Each year, the Secretary shall compile the notices published under paragraph (1)(B) and publish such compilation in the Federal Register. c ) Any susceptibility test interpretive criterion for which an approval is in effect under paragraph
(1)may be recognized as a standard by the Secretary under section 514(c)(1). Nothing in this section prohibits the sponsor of a drug or device from seeking approval or clearance of the drug or device, or changes to the drug, the device, or its labeling, on the basis of susceptibility test interpretive criteria which differ from those adopted pursuant to paragraph (1). In this section: The term qualified infectious disease product means a qualified infectious disease product designated under 505E(d). The term susceptibility test interpretive criteria means one or more specific values which characterize the degree to which bacteria or other microbes are resistant to the drug (or drugs) tested, such as clinically susceptible, intermediate, or resistant. . Section 1111 of the Food and Drug Administration Amendments Act of 2007 (42 U.S.C. 247d–5a; relating to identification of clinically susceptible concentrations of antimicrobials) is repealed. Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the progress made in implementing section 511 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360a ), as amended by this section.
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- 42 USC 247d–5a
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Sec. 3
Susceptibility test interpretive criteria for microbial organisms
Cite42 USC 247d–5a
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