[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>