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 or licensing of 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, susceptibility test interpretive criteria for such drugs based upon patient outcomes of mortality and morbidity from adequate and well-controlled studies and such other confirmatory evidence as the Secretary deems necessary; and update, consistent with subsection (b), such criteria as needed based upon scientific evidence of changes in patient outcomes.
As needed based on evidence related to changes in patient outcomes, the Secretary shall— evaluate any new scientific studies on changes in patient outcomes in relation to susceptibility test interpretive criteria; and publish on the public Website of the Food and Drug Administration a notice— presenting suggested new or updated interpretive criteria; and if needed, hold a public advisory committee to discuss scientific evidence related to changes in interpretative criteria. Each year, the Secretary shall compile the notices published under paragraph (1)(B) noting any changes from prior notices and publish such compilation in the Federal Register.
In this section, the term susceptibility test interpretive criteria means one or more specific values which characterize patient outcomes in relation to the degree to which bacteria or other microbes are more resistant to treatment as measured by patient outcomes. . 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of 2007 (42 U.S.C. 247d–5a; relating to identification of clinically susceptible concentrations of antimicrobials) is repealed.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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