[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2629 Introduced in House (IH)]

114th CONGRESS
  1st Session
                                H. R. 2629

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
 approval of certain antibacterial and antifungal drugs, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              June 3, 2015

 Mr. Shimkus (for himself and Mr. Gene Green of Texas) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
 approval of certain antibacterial and antifungal drugs, and for other 
                               purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Antibiotic Development to Advance 
Patient Treatment Act''.

SEC. 2. APPROVAL OF CERTAIN DRUGS FOR USE IN A LIMITED POPULATION OF 
              PATIENTS.

    (a) Purpose.--The purpose of this section is to help expedite the 
development and availability of treatments for serious or life-
threatening bacterial or fungal infections in patients with unmet 
needs, while maintaining safety and effectiveness standards for such 
treatments, taking into account the severity of the infection and the 
availability or lack of alternative treatments.
    (b) Approval of Certain Antibacterial and Antifungal Drugs.--
Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
is amended by adding at the end the following new subsection:
    ``(x) Approval of Certain Antibacterial and Antifungal Drugs for 
Use in a Limited Population of Patients.--
            ``(1) Process.--At the request of the sponsor of an 
        antibacterial or antifungal drug that is intended to treat a 
        serious or life-threatening infection, the Secretary--
                    ``(A) may execute a written agreement with the 
                sponsor on the process for developing data to support 
                an application for approval of such drug, for use in a 
                limited population of patients in accordance with this 
                subsection;
                    ``(B) shall proceed in accordance with this 
                subsection only if a written agreement is reached under 
                subparagraph (A);
                    ``(C) shall provide the sponsor with an opportunity 
                to request meetings under paragraph (2);
                    ``(D) if a written agreement is reached under 
                subparagraph (A), may approve the drug under this 
                subsection for such use--
                            ``(i) in a limited population of patients 
                        for which there is an unmet medical need;
                            ``(ii) based on a streamlined development 
                        program; and
                            ``(iii) only if the standards for approval 
                        under subsections (c) and (d) of this section 
                        or licensure under section 351 of the Public 
                        Health Service Act, as applicable, are met; and
                    ``(E) in approving a drug in accordance with this 
                subsection, subject to subparagraph (D)(iii), may rely 
                upon--
                            ``(i) traditional endpoints, alternate 
                        endpoints, or a combination of traditional and 
                        alternate endpoints, and, as appropriate, data 
                        sets of a limited size; and
                            ``(ii)(I) additional data, including 
                        preclinical, pharmacologic, or pathophysiologic 
                        evidence;
                            ``(II) nonclinical susceptibility and 
                        pharmacokinetic data;
                            ``(III) data from phase 2 clinical trials; 
                        and
                            ``(IV) such other confirmatory evidence as 
                        the Secretary determines appropriate to approve 
                        the drug.
            ``(2) Formal meetings.--
                    ``(A) In general.--To help expedite and facilitate 
                the development and review of a drug for which a 
                sponsor intends to request approval in accordance with 
                this subsection, the Secretary may, at the request of 
                the sponsor, conduct meetings that provide early 
                consultation, timely advice, and sufficient 
                opportunities to develop an agreement described in 
                paragraph (1)(A) and help the sponsor design and 
                conduct a drug development program as efficiently as 
                possible, including the following types of meetings:
                            ``(i) An early consultation meeting.
                            ``(ii) An assessment meeting.
                            ``(iii) A postapproval meeting.
                    ``(B) No altering of goals.--Nothing in this 
                paragraph shall be construed to alter agreed upon goals 
                and procedures identified in the letters described in 
                section 101(b) of the Prescription Drug User Fee 
                Amendments of 2012.
                    ``(C) Breakthrough therapies.--In the case of a 
                drug designated as a breakthrough therapy under section 
                506(a), the sponsor of such drug may elect to utilize 
                meetings provided under such section with respect to 
                such drug in lieu of meetings described in subparagraph 
                (A).
            ``(3) Labeling requirement.--The labeling of an 
        antibacterial or antifungal drug approved in accordance with 
        this subsection shall contain the statement `Limited 
        Population' in a prominent manner and adjacent to, and not more 
        prominent than, the brand name of the product. The prescribing 
        information for such antibacterial or antifungal drug required 
        by section 201.57 of title 21, Code of Federal Regulations (or 
        any successor regulation) shall also include the following 
        statement: `This drug is indicated for use in a limited and 
        specific population of patients.'.
            ``(4) Promotional materials.--The provisions of section 
        506(c)(2)(B) shall apply with respect to approval in accordance 
        with this subsection to the same extent and in the same manner 
        as such provisions apply with respect to accelerated approval 
        in accordance with section 506(c)(1).
            ``(5) Termination of requirements or conditions.--If a drug 
        is approved in accordance with this subsection for an 
        indication in a limited population of patients and is 
        subsequently approved or licensed under this section or section 
        351 of the Public Health Service Act, other than in accordance 
        with this subsection, for--
                    ``(A) the same indication and the same conditions 
                of use, the Secretary shall remove any labeling 
                requirements or postmarketing conditions that were made 
                applicable to the drug under this subsection; or
                    ``(B) a different indication or condition of use, 
                the Secretary shall not apply the labeling requirements 
                and postmarketing conditions that were made applicable 
                to the drug under this subsection to the subsequent 
                approval of the drug for such different indication or 
                condition of use.
            ``(6) Relation to other provisions.--Nothing in this 
        subsection shall be construed to prohibit the approval of a 
        drug for use in a limited population of patients in accordance 
        with this subsection, in combination with--
                    ``(A) an agreement on the design and size of a 
                clinical trial pursuant to subparagraphs (B) and (C) of 
                subsection (b)(5);
                    ``(B) designation and treatment of the drug as a 
                breakthrough therapy under section 506(a);
                    ``(C) designation and treatment of the drug as a 
                fast track product under section 506(b); or
                    ``(D) accelerated approval of the drug in 
                accordance with section 506(c).
            ``(7) Rule of construction.--Nothing in this subsection 
        shall be construed--
                    ``(A) to alter the standards of evidence under 
                subsection (c) or (d) (including the substantial 
                evidence standard in subsection (d));
                    ``(B) to waive or otherwise preclude the 
                application of requirements under subsection (o);
                    ``(C) to otherwise, in any way, limit the authority 
                of the Secretary to approve products pursuant to this 
                Act and the Public Health Service Act as authorized 
                prior to the date of enactment of this subsection; or
                    ``(D) to restrict in any manner, the prescribing of 
                antibiotics or other products by health care providers, 
                or to otherwise limit or restrict the practice of 
                health care.
            ``(8) Effective immediately.--The Secretary shall have the 
        authorities vested in the Secretary by this subsection 
        beginning on the date of enactment of this subsection, 
        irrespective of when and whether the Secretary promulgates 
        final regulations or guidance.
            ``(9) Definitions.--In this subsection:
                    ``(A) Early consultation meeting.--The term `early 
                consultation meeting' means a pre-investigational new 
                drug meeting or an end-of-phase 1 meeting that--
                            ``(i) is conducted to review and reach a 
                        written agreement--
                                    ``(I) on the scope of the 
                                streamlined development plan for a drug 
                                for which a sponsor intends to request 
                                approval in accordance with this 
                                subsection; and
                                    ``(II) which, as appropriate, may 
                                include agreement on the design and 
                                size of necessary preclinical and 
                                clinical studies early in the 
                                development process, including clinical 
                                trials whose data are intended to form 
                                the primary basis for an effectiveness 
                                claim; and
                            ``(ii) provides an opportunity to discuss 
                        expectations of the Secretary regarding studies 
                        or other information that the Secretary deems 
                        appropriate for purposes of applying paragraph 
                        (5), relating to the termination of labeling 
                        requirements or postmarketing conditions.
                    ``(B) Assessment meeting.--The term `assessment 
                meeting' means an end-of-phase 2 meeting, pre-new drug 
                application meeting, or pre-biologics license 
                application meeting conducted to resolve questions and 
                issues raised during the course of clinical 
                investigations, and details addressed in the written 
                agreement regarding postapproval commitments or 
                expansion of approved uses.
                    ``(C) Postapproval meeting.--The term `postapproval 
                meeting' means a meeting following initial approval or 
                licensure of the drug for use in a limited population, 
                to discuss any issues identified by the Secretary or 
                the sponsor regarding postapproval commitments or 
                expansion of approved uses.''.
    (c) Guidance.--Not later than 18 months after the date of enactment 
of this Act, the Secretary of Health and Human Services, acting through 
the Commissioner of Food and Drugs, shall issue draft guidance 
describing criteria, process, and other general considerations for 
demonstrating the safety and effectiveness of antibacterial and 
antifungal drugs to be approved for use in a limited population in 
accordance with section 505(x) of the Federal Food, Drug, and Cosmetic 
Act, as added by subsection (b).
    (d) Conforming Amendments.--
            (1) Licensure of certain biological products.--Section 
        351(j) of the Public Health Service Act (42 U.S.C. 262(j)) is 
        amended--
                    (A) by striking ``(j)'' and inserting ``(j)(1)'';
                    (B) by inserting ``505(x),'' after ``505(p),''; and
                    (C) by adding at the end the following new 
                paragraph:
    ``(2) In applying section 505(x) of the Federal Food, Drug, and 
Cosmetic Act to the licensure of biological products under this 
section--
            ``(A) references to an antibacterial or antifungal drug 
        that is intended to treat a serious or life-threatening 
        infection shall be construed to refer to a biological product 
        intended to treat a serious or life-threatening bacterial or 
        fungal infection; and
            ``(B) references to approval of a drug under section 505(c) 
        of such Act shall be construed to refer to a licensure of a 
        biological product under subsection (a) of this section.''.
            (2) Misbranding.--Section 502 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 352) is amended by adding at the 
        end the following new subsection:
    ``(dd) If it is a drug approved in accordance with section 505(x) 
and its labeling does not meet the requirements under paragraph (3) of 
such subsection, subject to paragraph (5) of such subsection.''.
    (e) Evaluation.--
            (1) Assessment.--Not later than 48 months after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall publish for public comment an assessment of the 
        program established under section 505(x) of the Federal Food, 
        Drug, and Cosmetic Act, as added by subsection (b). Such 
        assessment shall determine if the limited-use pathway 
        established under such section 505(x) has improved or is likely 
        to improve patient access to novel antibacterial or antifungal 
        treatments and assess how the pathway could be expanded to 
        cover products for serious or life-threatening diseases or 
        conditions beyond bacterial and fungal infections.
            (2) Meeting.--Not later than 90 days after the date of the 
        publication of such assessment, the Secretary, acting through 
        the Commissioner of Food and Drugs shall hold a public meeting 
        to discuss the findings of the assessment, during which public 
        stakeholders may present their views on the success of the 
        program established under section 505(x) of the Federal Food, 
        Drug, and Cosmetic Act, as added by subsection (b), and the 
        appropriateness of expanding such program.
    (f) Expansion of Program.--If the Secretary of Health and Human 
Services determines, based on the assessment under subsection (e)(1), 
evaluation of the assessment, and any other relevant information, that 
the public health would benefit from expansion of the limited-use 
pathway established under section 505(x) of the Federal Food, Drug, and 
Cosmetic Act (as added by subsection (b)) beyond the drugs approved in 
accordance with such section, the Secretary may expand such limited-use 
pathway in accordance with such a determination. The approval of any 
drugs under any such expansion shall be subject to the considerations 
and requirements described in such section 505(x) for purposes of 
expansion to other serious or life-threatening diseases or conditions.
    (g) Monitoring.--The Public Health Service Act is amended by 
inserting after section 317T (42 U.S.C. 247b-22) the following:

``SEC. 317U. MONITORING ANTIBACTERIAL AND ANTIFUNGAL DRUG USE AND 
              RESISTANCE.

    ``(a) Monitoring.--The Secretary shall use an appropriate 
monitoring system to monitor--
            ``(1) the use of antibacterial and antifungal drugs, 
        including those receiving approval or licensure for a limited 
        population pursuant to section 505(x) of the Federal Food, 
        Drug, and Cosmetic Act; and
            ``(2) changes in bacterial and fungal resistance to drugs.
    ``(b) Public Availability of Data.--The Secretary shall make 
summaries of the data derived from monitoring under this section 
publicly available for the purposes of--
            ``(1) improving the monitoring of important trends in 
        antibacterial and antifungal resistance; and
            ``(2) ensuring appropriate stewardship of antibacterial and 
        antifungal drugs, including those receiving approval or 
        licensure for a limited population pursuant to section 505(x) 
        of the Federal Food, Drug, and Cosmetic Act.''.

SEC. 3. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR MICROORGANISMS.

    (a) In General.--Section 511 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360a) is amended to read as follows:

``SEC. 511. IDENTIFYING AND UPDATING SUSCEPTIBILITY TEST INTERPRETIVE 
              CRITERIA FOR MICROORGANISMS.

    ``(a) Purpose; Identification of Criteria.--
            ``(1) Purpose.--The purpose of this section is to provide 
        the Secretary with an expedited, flexible method for--
                    ``(A) clearance or premarket approval of 
                antimicrobial susceptibility testing devices utilizing 
                updated, recognized susceptibility test interpretive 
                criteria to characterize the in vitro susceptibility of 
                particular bacteria, fungi, or other microorganisms to 
                antimicrobial drugs; and
                    ``(B) providing public notice of the availability 
                of recognized interpretive criteria to meet premarket 
                submission requirements or other requirements under 
                this Act for antimicrobial susceptibility testing 
                devices.
            ``(2) In general.--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) Bayesian and pharmacometric statistical 
                methodologies; 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 Antibiotic Development to Advance Patient 
        Treatment 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 
        in accordance with paragraph (2) (referred to in this section 
        as the `Interpretive Criteria Website').
            ``(2) Listing of susceptibility test interpretive criteria 
        standards.--
                    ``(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)(B) 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 of limitations of 
                information.--The Interpretive Criteria Website shall 
                include the following:
                            ``(i) A statement that--
                                    ``(I) the website provides 
                                information about the susceptibility of 
                                bacteria, fungi, or other 
                                microorganisms to a certain drug (or 
                                drugs); and
                                    ``(II) the safety and efficacy of 
                                the drug in treating clinical 
                                infections due to such bacteria, fungi, 
                                or other microorganisms may not have 
                                been established in adequate and well-
                                controlled clinical trials and the 
                                clinical significance of such 
                                susceptibility information in such 
                                trials is unknown.
                            ``(ii) A statement that directs health care 
                        practitioners to consult the approved product 
                        labeling for specific drugs to determine the 
                        uses for which the Food and Drug Administration 
                        has approved the product.
                            ``(iii) Any other statement that the 
                        Secretary determines appropriate to adequately 
                        convey the limitations of the data supporting 
                        susceptibility test interpretive criteria 
                        standard listed 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, or the regulations promulgated 
        thereunder.
            ``(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 From 
Standard Development Organizations.--
            ``(1) In general.--Beginning on the date of the 
        establishment of the Interpretive Criteria Website, and at 
        least every 6 months thereafter, the Secretary shall--
                    ``(A) 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
                    ``(B) 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).
            ``(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)(B) and publish such compilation in the Federal Register and 
        provide for public comment. If the Secretary receives comments, 
        the Secretary will review such comments and, if the Secretary 
        determines appropriate, update pursuant to this subsection 
        susceptibility test interpretive criteria standards--
                    ``(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 standards which differ from those recognized pursuant 
        to paragraph (1).
    ``(d) Antimicrobial Drug Labeling.--
            ``(1) Drugs marketed prior to establishment of interpretive 
        criteria website.--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 or section 351 of the 
        Public Health Service Act, as applicable, for each such drug--
                    ``(A) not later than 1 year after establishment of 
                the Interpretive Criteria Website, shall submit to the 
                Secretary a supplemental application for purposes of 
                changing the drug's labeling to substitute a reference 
                or hyperlink to such Website for any susceptibility 
                test interpretive criteria and related information; and
                    ``(B) may begin distribution of the drug involved 
                upon receipt by the Secretary of the supplemental 
                application for such change.
            ``(2) Drugs marketed subsequent to establishment of 
        interpretive criteria website.--With respect to antimicrobial 
        drugs lawfully introduced or delivered for introduction into 
        interstate commerce for commercial distribution on or after the 
        date of the establishment of the Interpretive Criteria Website, 
        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, 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 prominently and 
                conspicuously--
                            ``(i)  includes a statement that--
                                    ``(I) the device provides 
                                information about the susceptibility of 
                                bacteria and fungi to certain drugs; 
                                and
                                    ``(II) the safety and efficacy of 
                                such drugs in treating clinical 
                                infections due to such bacteria or 
                                fungi may not have been established in 
                                adequate and well-controlled clinical 
                                trials and the clinical significance of 
                                such susceptibility information in 
                                those instances is unknown;
                            ``(ii) includes a statement directing 
                        health care practitioners to consult the 
                        approved labeling for drugs tested using such a 
                        device, to determine the uses for which the 
                        Food and Drug Administration has approved such 
                        drugs; and
                            ``(iii) includes any other statement the 
                        Secretary determines appropriate to adequately 
                        convey the limitations of the data supporting 
                        the interpretive criteria described in 
                        subparagraph (A).
    ``(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. 
    ``(g) Rule of Construction.--Nothing in this section shall be 
construed--
            ``(1) to alter the standards of evidence--
                    ``(A) under subsection (c) or (d) of section 505, 
                including the substantial evidence standard in section 
                505(d), or under section 351 of the Public Health 
                Service Act (as applicable); or
                    ``(B) with respect to marketing authorization for 
                devices, under section 510, 513, or 515;
            ``(2) to apply with respect to any drug, device, or 
        biological product, in any context other than--
                    ``(A) an antimicrobial drug; or
                    ``(B) an antimicrobial susceptibility testing 
                device that uses susceptibility test interpretive 
                criteria to characterize and report the in vitro 
                susceptibility of certain bacteria, fungi, or other 
                microorganisms to antimicrobial drugs in accordance 
                with this section; or
            ``(3) unless specifically stated, to 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 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) Misbranding.--Section 502 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 352), as amended by section 1, is 
        further amended by adding at the end the following:
    ``(ee) If it is an antimicrobial drug and its labeling fails to 
conform with the requirements under section 511(d).''.
            (3) Recognition of interpretive criteria 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 susceptibility 
        test interpretive criteria or standards recognized or otherwise 
        listed under section 511, by posting on the Interpretive 
        Criteria Website in accordance with such section)''.
    (c) Report to Congress.--Not later than two years 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.
    (d) Requests for Updates to Interpretive Criteria Website.--Chapter 
35 of title 44, United States Code, shall not apply to the collection 
of information from interested parties regarding the updating of lists 
under paragraph (2) of subsection (b) of section 511 of the Federal 
Food, Drug, and Cosmetic Act (as amended by subsection (a)) and posted 
on the Interpretive Criteria Website established under paragraph (1) of 
such subsection (b).
    (e) No Effect on Health Care Practice.--Nothing in this Act 
(including the amendments made by this Act) shall be construed to 
restrict, in any manner, the prescribing or administering of 
antibiotics or other products by health care practitioners, or to limit 
the practice of health care.
                                 <all>