I 
113TH CONGRESS 
1ST SESSION H. R. 3742 
To provide for approval of certain drugs and biological products indicated 
for use in a limited population of patients in order to address increases 
in bacterial and fungal resistance to drugs and biological products, and 
for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 12, 2013 
Mr. GINGREY of Georgia (for himself, Mr. GENE GREEN of Texas, Mr. SHIM-
KUS, Ms. ESHOO, Mr. WHITFIELD, Ms. DEGETTE, Mrs. BLACKBURN, 
Mr. ENGEL, Mr. GRIFFITH of Virginia, and Mr. BUTTERFIELD) intro-
duced the following bill; which was referred to the Committee on Energy 
and Commerce 
A BILL 
To provide for approval of certain drugs and biological prod-
ucts indicated for use in a limited population of patients 
in order to address increases in bacterial and fungal 
resistance to drugs and biological products, and for other 
purposes. 
Be it enacted by the Senate and House of Representa-
tives 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 of 2013’’. 
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SEC. 2. APPROVAL OF CERTAIN DRUGS FOR USE IN A LIM-
ITED POPULATION OF PATIENTS. 
(a) 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: 
‘‘(x) APPROVAL OF CERTAIN ANTIBACTERIAL AND 
ANTIFUNGAL DRUGS
FOR USE
IN
A LIMITED POPU-
LATION OF PATIENTS.— 
‘‘(1) APPROVAL.—At the request of the sponsor 
of an antibacterial or antifungal drug that is in-
tended to treat a serious or life-threatening disease 
or condition, the Secretary— 
‘‘(A) may approve the drug under sub-
section (c) to treat a limited population of pa-
tients for which there is an unmet medical 
need; 
‘‘(B) in determining whether to grant such 
approval for a limited population of patients, 
may rely on traditional endpoints, alternative 
endpoints, or a combination of traditional and 
alternative endpoints; datasets of limited size; 
pharmacologic or pathophysiologic data; data 
from phase 2 clinical studies; and such other 
confirmatory evidence as the Secretary deems 
necessary; and 
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‘‘(C) shall require the labeling of drugs ap-
proved pursuant to this subsection to promi-
nently include in the prescribing information re-
quired by section 201.57 of title 21, Code of 
Federal Regulations (or any successor regula-
tion) the following statement: ‘This drug is in-
dicated for use in a limited and specific popu-
lation of patients.’. 
‘‘(2) PROMOTIONAL
MATERIALS.—The provi-
sions of section 506(c)(2)(B) shall apply with re-
spect to approval under this subsection to the same 
extent and in the same manner as such provisions 
apply with respect to accelerated approval under sec-
tion 506(c)(1). 
‘‘(3) WITHDRAWAL
OF
LIMITED
POPULATION 
APPROVAL REQUIREMENTS.—If a drug is approved 
pursuant to this subsection to treat a limited popu-
lation of patients and is subsequently approved or li-
censed under this section or section 351 of the Pub-
lic Health Service Act, respectively, without such a 
limitation, the Secretary may remove any labeling 
requirements or postmarketing conditions made ap-
plicable to the drug during the earlier approval proc-
ess. 
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‘‘(4) RELATION TO OTHER PROVISIONS.—Noth-
ing in this subsection shall be construed to prohibit 
designation and expedited review of a drug as a 
breakthrough therapy under section 506(a), designa-
tion and treatment of a drug as a fast track product 
under section 506(b), or accelerated approval of the 
drug under section 506(c), in combination with ap-
proval of the drug for use in a limited population of 
patients under this subsection. 
‘‘(5) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection shall be construed to alter the stand-
ards of evidence under subsection (c) or (d) (includ-
ing the substantial evidence standard in subsection 
(d)). Subsections (c) and (d) and such standards of 
evidence apply to the review and approval of drugs 
under this subsection, including whether a drug is 
safe and effective. Nothing in this subsection shall 
be construed to 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. 
‘‘(6) EFFECTIVE
IMMEDIATELY.—The Sec-
retary shall have the authorities vested in the Sec-
retary by this subsection beginning on the date of 
enactment of this subsection, irrespective of when 
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and whether the Secretary promulgates final regula-
tions to carry out this subsection.’’. 
(b) LICENSURE
OF CERTAIN BIOLOGICAL PROD-
UCTS.—Section 351(j) of the Public Health Service Act 
(42 U.S.C. 262(j)) is amended— 
(1) by striking ‘‘(j)’’ and inserting ‘‘(j)(1)’’; 
(2) by inserting ‘‘505(x),’’ after ‘‘505(p),’’; and 
(3) by adding at the end the following: 
‘‘(2) In applying section 505(x) of the Federal 
Food, Drug, and Cosmetic Act to the licensure of bi-
ological products under this section— 
‘‘(A) references to an antibacterial or 
antifungal drug that is intended to treat a seri-
ous or life-threatening disease or condition shall 
be construed to refer to biological products in-
tended to treat a bacterial or fungal infection 
associated with a serious or life-threatening dis-
ease; and 
‘‘(B) references to approval of a drug 
under section 505(c) of such Act shall be con-
strued to refer to licensure of a biological prod-
uct under subsection (a) of this section.’’. 
(c) MONITORING.—Title III of the Public Health 
Service Act is amended by inserting after section 317T 
(42 U.S.C. 247b–22) the following: 
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‘‘SEC. 
317U. 
MONITORING 
ANTIBACTERIAL 
AND 
ANTIFUNGAL DRUG USE AND RESISTANCE. 
‘‘(a) MONITORING.—The Secretary, acting through 
the Director of the Centers for Disease Control and Pre-
vention, shall use the National Healthcare Safety Network 
or another 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 Sec-
retary, acting through the Director of the Centers for Dis-
ease Control and Prevention, shall make 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 anti-
bacterial and antifungal drugs, including those re-
ceiving approval or licensure for a limited population 
pursuant to section 505(x) of the Federal Food, 
Drug, and Cosmetic Act.’’. 
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SEC. 3. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA 
FOR MICROBIAL ORGANISMS. 
(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. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA 
FOR MICROBIAL ORGANISMS. 
‘‘(a) IN GENERAL.—The Secretary shall identify 
upon approval and subsequently update susceptibility test 
interpretive criteria for antibacterial drugs (including bio-
logical products intended to treat a bacterial infection and 
other types of antimicrobial drugs, as deemed appropriate 
by the Secretary), including qualified infectious disease 
products, by relying upon, to the extent available— 
‘‘(1) preclinical and clinical data, including 
pharmacokinetic, pharmacodynamic, and epidemio-
logical data; 
‘‘(2) Bayesian and pharmacometric statistical 
methodologies; and 
‘‘(3) such other confirmatory evidence as the 
Secretary deems necessary. 
‘‘(b) RESPONDING TO SUSCEPTIBILITY TEST INTER-
PRETIVE CRITERIA IDENTIFIED OR UPDATED BY PRI-
VATE ENTITIES.— 
‘‘(1) IN GENERAL.—Each quarter of each fiscal 
year, the Secretary shall— 
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‘‘(A) evaluate any appropriate new or up-
dated susceptibility test interpretive criteria 
published by a nationally or internationally rec-
ognized standard development organization; and 
‘‘(B) publish on the public Website of the 
Food and Drug Administration a notice— 
‘‘(i) adopting the new or updated in-
terpretive criteria; 
‘‘(ii) declining to adopt the new or up-
dated interpretive criteria and explaining 
the reason for such decision; or 
‘‘(iii) adopting one or more parts of 
the new or updated interpretive criteria, 
declining to adopt the remainder of such 
criteria, and explaining the reason for so 
declining. 
‘‘(2) 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. 
‘‘(3) RELATION TO SECTION 514(c).—Any sus-
ceptibility test interpretive criterion for which an ap-
proval is in effect under paragraph (1) may be rec-
ognized as a standard by the Secretary under sec-
tion 514(c)(1). 
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‘‘(4) USE OF NON-ADOPTED CRITERIA.—Noth-
ing in this section prohibits the sponsor of a drug 
or device from seeking approval or clearance of the 
drug or device, or changes to the drug, the device, 
or its labeling, on the basis of susceptibility test in-
terpretive criteria which differ from those adopted 
pursuant to paragraph (1). 
‘‘(c) DEFINITIONS.—In this section: 
‘‘(1) The term ‘qualified infectious disease 
product’ means a qualified infectious disease product 
designated under 505E(d). 
‘‘(2) The term ‘susceptibility test interpretive 
criteria’ means one or more specific values which 
characterize the degree to which bacteria or other 
microbes are resistant to the drug (or drugs) tested, 
such as clinically susceptible, intermediate, or resist-
ant.’’. 
(b) CONFORMING AMENDMENT.—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. 
(c) REPORT TO CONGRESS.—Not later than one year 
after the date of enactment of this Act, the Secretary of 
Health and Human Services shall submit to the Com-
mittee on Energy and Commerce of the House of Rep-
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resentatives 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. 
SEC. 4. NO EFFECT ON HEALTH CARE PRACTICE. 
Nothing in the Antibiotic Development to Advance 
Patient Treatment Act of 2013 (including the amend-
ments made thereby) shall be construed to restrict, in any 
manner, the prescribing of antibiotics or other products 
by health care professionals, or to limit the practice of 
health care. 
Æ 
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