Sec. 3044. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR MICROORGANISMS; ANTIMICROBIAL SUSCEPTIBILITY TESTING DEVICES

3,369 words·~15 min read·/statute-compilations/comps-13005/sec-3044

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

## SEC. 3044 SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR MICROORGANISMS; ANTIMICROBIAL SUSCEPTIBILITY TESTING DEVICES ###

(a)In general Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 511 the following: > > ## “SEC. 511A SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR MICROORGANISMS > > **[**[21 U.S.C. 360a-2](/us/usc/t21/s360a-2)**]** > > > ### “(a) Purpose; Identification of Criteria > > > #### “(1) Purpose > > The purpose of this section is to clarify the Secretary’s authority to— > > > ##### “(A) > > efficiently update susceptibility test interpretive criteria for antimicrobial drugs when necessary for public health, due to, among other things, the constant evolution of microorganisms that leads to the development of resistance to drugs that have been effective in decreasing morbidity and mortality for patients, which warrants unique management of antimicrobial drugs that is inappropriate for most other drugs in order to delay or prevent the development of further resistance to existing therapies; > > > ##### “(B) > > provide for public notice of the availability of recognized interpretive criteria and interpretive criteria standards; and > > > ##### “(C) > > clear under section 510(k), classify under section 513(f)(2), or approve under section 515, antimicrobial susceptibility testing devices utilizing updated, recognized susceptibility test interpretive criteria to characterize the in vitro susceptibility of particular bacteria, fungi, or other microorganisms, as applicable, to antimicrobial drugs. > > > #### “(2) Identification of criteria > > The Secretary shall identify appropriate susceptibility test interpretive criteria with respect to antimicrobial drugs— > > > ##### “(A) > > if such criteria are available on the date of approval of the drug under section 505 of this Act or licensure of the drug under section 351 of the Public Health Service Act (as applicable), upon such approval or licensure; or > > > ##### “(B) > > if such criteria are unavailable on such date, on the date on which such criteria are available for such drug. > > > #### “(3) Bases for initial identification > > The Secretary shall identify appropriate susceptibility test interpretive criteria under paragraph (2), based on the Secretary’s review of, to the extent available and relevant— > > > ##### “(A) > > preclinical and clinical data, including pharmacokinetic, pharmacodynamic, and epidemiological data; > > > ##### “(B) > > the relationship of susceptibility test interpretive criteria to morbidity and mortality associated with the disease or condition for which such drug is used; and > > > ##### “(C) > > such other evidence and information as the Secretary considers appropriate. > > > ### “(b) Susceptibility Test Interpretive Criteria Website > > > #### “(1) In general > > Not later than 1 year after the date of the enactment of the 21st Century Cures Act, the Secretary shall establish, and maintain thereafter, on the website of the Food and Drug Administration, a dedicated website that contains a list of any appropriate new or updated susceptibility test interpretive criteria standards and interpretive criteria in accordance with paragraph

(2)(referred to in this section as the ‘Interpretive Criteria Website’). > > > #### “(2) Listing of susceptibility test interpretive criteria standards and interpretive criteria > > > ##### “(A) In general > > The list described in paragraph

(1)shall consist of any new or updated susceptibility test interpretive criteria standards that are— > > > ###### “(i) > > established by a nationally or internationally recognized standard development organization that— > > > ###### “(I) > > establishes and maintains procedures to address potential conflicts of interest and ensure transparent decisionmaking; > > > ###### “(II) > > holds open meetings to ensure that there is an opportunity for public input by interested parties, and establishes and maintains processes to ensure that such input is considered in decisionmaking; and > > > ###### “(III) > > permits its standards to be made publicly available, through the National Library of Medicine or another similar source acceptable to the Secretary; and > > > ###### “(ii) > > recognized in whole, or in part, by the Secretary under subsection (c). > > > ##### “(B) Other list > > The Interpretive Criteria Website shall, in addition to the list described in subparagraph (A), include a list of interpretive criteria, if any, that the Secretary has determined to be appropriate with respect to legally marketed antimicrobial drugs, where— > > > ###### “(i) > > the Secretary does not recognize, in whole or in part, an interpretive criteria standard described under subparagraph

(A)otherwise applicable to such a drug; > > > ###### “(ii) > > the Secretary withdraws under subsection (c)(1)(A) recognition of a standard, in whole or in part, otherwise applicable to such a drug; > > > ###### “(iii) > > the Secretary approves an application under section 505 of this Act or section 351 of the Public Health Service Act, as applicable, with respect to marketing of such a drug for which there are no relevant interpretive criteria included in a standard recognized by the Secretary under subsection (c); or > > > ###### “(iv) > > because the characteristics of such a drug differ from other drugs with the same active ingredient, the interpretive criteria with respect to such drug— > > > ###### “(I) > > differ from otherwise applicable interpretive criteria included in a standard listed under subparagraph

(A)or interpretive criteria otherwise listed under this subparagraph; and > > > ###### “(II) > > are determined by the Secretary to be appropriate for the drug. > > > ##### “(C) Required statements > > The Interpretive Criteria Website shall include statements conveying— > > > ###### “(i) > > that the website provides information about the in vitro susceptibility of bacteria, fungi, or other microorganisms, as applicable to a certain drug (or drugs); > > > ###### “(ii) > > that— > > > ###### “(I) > > the safety and efficacy of such drugs in treating clinical infections due to such bacteria, fungi, or other microorganisms, as applicable, may or may not have been established in adequate and well-controlled clinical trials in order for the susceptibility information described in clause

(i)to be included on the website; and > > > ###### “(II) > > the clinical significance of such susceptibility information in such instances is unknown; > > > ###### “(iii) > > that the approved product labeling for specific drugs provides the uses for which the Secretary has approved the product; and > > > ###### “(iv) > > any other information that the Secretary determines appropriate to adequately convey the meaning of the data supporting the recognition or listing of susceptibility test interpretive criteria standards or susceptibility test interpretive criteria included on the website. > > > #### “(3) Notice > > Not later than the date on which the Interpretive Criteria Website is established, the Secretary shall publish a notice of that establishment in the Federal Register. > > > #### “(4) Inapplicability of misbranding provision > > The inclusion in the approved labeling of an antimicrobial drug of a reference or hyperlink to the Interpretive Criteria Website, in and of itself, shall not cause the drug to be misbranded in violation of section 502. > > > #### “(5) Trade secrets and confidential information > > Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code. > > > ### “(c) Recognition of Susceptibility Test Interpretive Criteria > > > #### “(1) Evaluation and publication > > > ##### “(A) In general > > Beginning on the date of the establishment of the Interpretive Criteria Website, and at least every 6 months thereafter, the Secretary shall— > > > ###### “(i) > > evaluate any appropriate new or updated susceptibility test interpretive criteria standards established by a nationally or internationally recognized standard development organization described in subsection (b)(2)(A)(i); and > > > ###### “(ii) > > publish on the public website of the Food and Drug Administration a notice**— > > > ###### “(I) > > withdrawing recognition of any different susceptibility test interpretive criteria standard, in whole or in part; > > > ###### “(II) > > recognizing the new or updated standards; > > > ###### “(III) > > recognizing one or more parts of the new or updated interpretive criteria specified in such a standard and declining to recognize the remainder of such standard; and > > > ###### “(IV) > > making any necessary updates to the lists under subsection (b)(2). > > > ##### “(B) Upon approval of a drug > > Upon the approval of an initial or supplemental application for an antimicrobial drug under section 505 of this Act or section 351 of the Public Health Service Act, as applicable, where such approval is based on susceptibility test interpretive criteria which differ from those contained in a standard recognized, or from those otherwise listed, by the Secretary pursuant to this subsection, or for which there are no relevant interpretive criteria standards recognized, or interpretive criteria otherwise listed, by the Secretary pursuant to this subsection, the Secretary shall update the lists under subparagraphs

(A)and

(B)of subsection (b)(2) to include the susceptibility test interpretive criteria upon which such approval was based. > > > #### “(2) Bases for updating interpretive criteria standards > > In evaluating new or updated susceptibility test interpretive criteria standards under paragraph (1)(A), the Secretary may consider— > > > ##### “(A) > > the Secretary’s determination that such a standard is not applicable to a particular drug because the characteristics of the drug differ from other drugs with the same active ingredient; > > > ##### “(B) > > information provided by interested third parties, including public comment on the annual compilation of notices published under paragraph (3); > > > ##### “(C) > > any bases used to identify susceptibility test interpretive criteria under subsection (a)(2); and > > > ##### “(D) > > such other information or factors as the Secretary determines appropriate. > > > #### “(3) Annual compilation of notices > > Each year, the Secretary shall compile the notices published under paragraph (1)(A) and publish such compilation in the Federal Register and provide for public comment. If the Secretary receives comments, the Secretary shall review such comments and, if the Secretary determines appropriate, update pursuant to this subsection susceptibility test interpretive criteria standards or criteria— > > > ##### “(A) > > recognized by the Secretary under this subsection; or > > > ##### “(B) > > otherwise listed on the Interpretive Criteria Website under subsection (b)(2). > > > #### “(4) Relation to section 514(c) > > Any susceptibility test interpretive standard recognized under this subsection or any criteria otherwise listed under subsection (b)(2)(B) shall be deemed to be recognized as a standard by the Secretary under section 514(c)(1). > > > #### “(5) Voluntary use of interpretive criteria > > Nothing in this section prohibits a person from seeking approval or clearance of a drug or device, or changes to the drug or the device, on the basis of susceptibility test interpretive criteria which differ from those contained in a standard recognized, or from those otherwise listed, by the Secretary pursuant to subsection (b)(2). > > > ### “(d) Antimicrobial Drug Labeling > > > #### “(1) Drugs marketed prior to establishment of interpretive criteria website > > > ##### “(A) In general > > With respect to an antimicrobial drug lawfully introduced or delivered for introduction into interstate commerce for commercial distribution before the establishment of the Interpretive Criteria Website, a holder of an approved application under section 505 of this Act or section 351 of the Public Health Service Act, as applicable, for each such drug, not later than 1 year after establishment of the Interpretive Criteria Website described in subsection (b)(1), shall remove susceptibility test interpretive criteria, if any, and related information from the approved drug labeling and replace it with a reference to the Interpretive Criteria Website. > > > ##### “(B) Labeling changes > > The labeling changes required by this section shall be considered a minor change under section 314.70 of title 21, Code of Federal Regulations (or any successor regulations) that may be implemented through documentation in the next applicable annual report. > > > #### “(2) Drugs marketed subsequent to establishment of interpretive criteria website > > With respect to antimicrobial drugs approved on or after the date of the establishment of the Interpretive Criteria Website described in subsection (b)(1), the labeling for such a drug shall include, in lieu of susceptibility test interpretive criteria and related information, a reference to such Website. > > > ### “(e) Special Condition for Marketing of Antimicrobial Susceptibility Testing Devices > > > #### “(1) In general > > Notwithstanding sections 501, 502, 505, 510, 513, and 515, if the conditions specified in paragraph

(2)are met (in addition to other applicable provisions under this chapter) with respect to an antimicrobial susceptibility testing device described in subsection (f)(1), the Secretary may authorize the marketing of such device for a use described in such subsection. > > > #### “(2) Conditions applicable to antimicrobial susceptibility testing devices > > The conditions specified in this paragraph are the following: > > > ##### “(A) > > The device is used to make a determination of susceptibility using susceptibility test interpretive criteria that are— > > > ###### “(i) > > included in a standard recognized by the Secretary under subsection (c); or > > > ###### “(ii) > > otherwise listed on the Interpretive Criteria Website under subsection (b)(2). > > > ##### “(B) > > The labeling of such device includes statements conveying— > > > ###### “(i) > > that the device provides information about the in vitro susceptibility of bacteria, fungi, or other microorganisms, as applicable to antimicrobial drugs; > > > ###### “(ii) > > that— > > > ###### “(I) > > the safety and efficacy of such drugs in treating clinical infections due to such bacteria, fungi, or other microorganisms, as applicable, may or may not have been established in adequate and well-controlled clinical trials in order for the device to report the susceptibility of such bacteria, fungi, or other microorganisms, as applicable, to such drugs; and > > > ###### “(II) > > the clinical significance of such susceptibility information in those instances is unknown; > > > ###### “(iii) > > that the approved labeling for drugs tested using such a device provides the uses for which the Secretary has approved such drugs; and > > > ###### “(iv) > > any other information the Secretary determines appropriate to adequately convey the meaning of the data supporting the recognition or listing of susceptibility test interpretive criteria standards or susceptibility test interpretive criteria described in subparagraph (A). > > > ##### “(C) > > The antimicrobial susceptibility testing device meets all other requirements to be cleared under section 510(k), classified under section 513(f)(2), or approved under section 515. > > > ### “(f) Definitions > > In this section: > > > #### “(1) > > The term ‘antimicrobial susceptibility testing device’ means a device that utilizes susceptibility test interpretive criteria to determine and report the in vitro susceptibility of certain microorganisms to a drug (or drugs). > > > #### “(2) > > The term ‘qualified infectious disease product’ means a qualified infectious disease product designated under section 505E(d). > > > #### “(3) > > The term ‘susceptibility test interpretive criteria’ means— > > > ##### “(A) > > one or more specific numerical values which characterize the susceptibility of bacteria or other microorganisms to the drug tested; and > > > ##### “(B) > > related categorizations of such susceptibility, including categorization of the drug as susceptible, intermediate, resistant, or such other term as the Secretary determines appropriate. > > > #### “(4) > > > #####

(A)> > The term ‘antimicrobial drug’ means, subject to subparagraph (B), a systemic antibacterial or antifungal drug that— > > > ###### “(i) > > is intended for human use in the treatment of a disease or condition caused by a bacterium or fungus; > > > ###### “(ii) > > may include a qualified infectious disease product designated under section 505E(d); and > > > ###### “(iii) > > is subject to section 503(b)(1). > > > ##### “(B) > > If provided by the Secretary through regulations, such term may include— > > > ###### “(i) > > drugs other than systemic antibacterial and antifungal drugs; and > > > ###### “(ii) > > biological products (as such term is defined in section 351 of the Public Health Service Act) to the extent such products exhibit antimicrobial activity. ** > > > #### “(5) > > The term ‘interpretive criteria standard’ means a compilation of susceptibility test interpretive criteria developed by a standard development organization that meets the criteria set forth in subsection (b)(2)(A)(i). > > > ### “(g) Rule of Construction > > Nothing in this section shall be construed to— > > > #### “(1) > > alter the standards of evidence under subsection

(c)or

(d)of section 505 (including the substantial evidence standard under section 505(d)) or under section 351 of the Public Health Service Act (as applicable); or > > > #### “(2) > > with respect to clearing devices under section 510(k), classifying devices under section 513(f)(2), or approving devices under section 515— > > > ##### “(A) > > apply with respect to any drug, device, or biological product, in any context other than an antimicrobial drug and an antimicrobial susceptibility testing device that uses susceptibility test interpretive criteria to characterize and report the susceptibility of certain bacteria, fungi, or other microorganisms, as applicable, to such drug to reflect patient morbidity and mortality in accordance with this section; or > > > ##### “(B) > > unless specifically stated, have any effect on authorities provided under other sections of this Act, including any regulations issued under such sections.” > . ###

(b)Conforming amendments ####

(1)Repeal of prior related authority 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. ####

(2)Addition to categories of misbranded drugs Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following: > > ###### “(dd) > > If it is an antimicrobial drug, as defined in section 511A(f), and its labeling fails to conform with the requirements under section 511A(d).” > . ####

(3)Recognition of interpretive criteria standard as device standard Section 514(c)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)(1)(A)) is amended by inserting after “the Secretary shall, by publication in the Federal Register” the following: “(or, with respect to a susceptibility test interpretive criteria standard under section 511A, by posting on the Interpretive Criteria Website in accordance with such section)”. ###

(c)Report to Congress Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the progress made in implementing section 511A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360a), as added by subsection (a). ###

(d)Requests for Updates to Interpretive Criteria Website **[**[21 U.S.C. 360a-2 note](/us/usc/t21/s360a-2)**]** Chapter 35 of title 44, United States Code, shall not apply to the collection of information from interested parties regarding updating the lists established under section 511A(b) of the Federal Food, Drug, and Cosmetic Act and posted on the Interpretive Criteria Website established under section 511A(c) of such Act. ## Subtitle F Medical Device Innovations

Connectionstraces to 6

Traces to 6 documents

U.S. Code

Citation graph

cites case law

Sec. 3044

SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR MICROORGANISMS; ANTIMICROBIAL SUSCEPTIBILITY TESTING DEVICES

Cites 6Cited by 0 across 0 sources