
[Federal Register Volume 78, Number 105 (Friday, May 31, 2013)]
[Notices]
[Pages 32669-32670]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12925]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0556]


New Approaches to Antibacterial Drug Development; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration's (FDA) Center for Drug 
Evaluation and Research (CDER) is seeking input from the public on the 
following topics related to antibacterial drug development: Potential 
new study designs, proposed priorities for CDER guidances, and 
strategies intended to slow the rate of emerging resistance to 
antibacterial drugs. The purpose of this notice is to request 
information and comments from the public on these areas of focus.

DATES: Submit either electronic or written comments by July 30, 2013 at 
5 p.m. EST.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jonas Santiago, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-5346, FAX: 301-
847-3529, email: jonas.santiago@fda.hhs.gov.

I. Background

    Antibacterial drug development is critical to the public health and 
is an FDA priority. We recognize the mounting concern that 
antibacterial drug development has not kept pace with the increasing 
threat of drug-resistant and untreatable infections.
    To address this concern, we are seeking to explore new clinical 
development paradigms for antibacterial drugs. Areas of ongoing need 
are numerous and include new drugs for treatment of hospital-acquired 
bacterial pneumonia, ventilator-associated bacterial pneumonia, 
complicated urinary tract infection, complicated intra-abdominal 
infection, and infections caused by drug-resistant organisms.
    On September 24, 2012,\1\ FDA announced the formation of the CDER 
Antibacterial Drug Development Task Force, which supports new 
antibacterial drug development. The task force is a multidisciplinary 
group of CDER scientists and clinicians seeking to identify priority 
areas and to develop and implement possible solutions to the challenges 
of antibacterial drug development. This includes the use of existing 
partnerships and collaborations to work with other experts in the 
field, including academia, industry, professional societies, patient 
advocacy groups, and Government Agencies. Specifically, the task force 
seeks to:
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    \1\ FDA's press release is available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm320643.htm.
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     Explore novel scientific approaches to facilitate 
antibacterial drug development (e.g., broader use of clinical 
pharmacology data, new statistical methods, innovative clinical trial 
designs, use of additional available data sources, and advancement of 
alternative measures to evaluate clinical effectiveness of potential 
new therapies);
     Identify issues related to unmet medical need for 
antibacterial drugs, including the reasons for the lack of a robust 
pipeline for antibacterial drug development;
     Identify new approaches for weighing risks, benefits, and 
uncertainties of potential new antibacterial drugs addressing unmet 
need; and
     Evaluate existing FDA guidances related to antibacterial 
drug development to determine if revision or elaboration is needed and 
identify areas where future guidance would be helpful.

II. Potential New Study Design Approaches

    The task force explores novel scientific approaches to facilitate 
antibacterial drug development and is seeking input from the public on 
study design approaches with potential utility for future antibacterial 
drug development. Possible elements being considered include:
     Bayesian approaches;
     Adaptive approaches;
     Use of novel point of care diagnostics to avoid use of 
confounding therapies;
     Evaluating safety and efficacy by enrolling patients in 
trials with infections at any one of a number of different body sites;
     Large simple trials; and
     Accelerated approval using either a surrogate endpoint 
reasonably likely to predict clinical benefit or on a clinical endpoint 
that can be measured earlier than irreversible morbidity or mortality 
(IMM) that is reasonably likely to predict an effect on IMM or other 
clinical benefit.
    To advance the development of antibacterial drugs, we seek input on 
the listed examples as well as additional ideas regarding the design, 
conduct, and analysis of clinical trials.

III. Guidance Development

    The task force focuses on developing guidance to address issues 
related to development of new antibacterial drugs. Initial guidance 
efforts focused on community-acquired bacterial pneumonia, acute 
bacterial skin and skin structure infections, and antibacterial drugs 
for patients with limited or no alternative therapies (including 
development of drugs that have a limited spectrum of activity). As the 
task force works to prioritize areas of future draft and final guidance 
development, we seek input from the public on the following areas of 
priority as well as on additional areas for potential future guidance 
development:

[[Page 32670]]

     Complicated Urinary Tract Infection (draft issued February 
23, 2012); \2\
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    \2\ Complicated Urinary Tract Infection Draft Guidance available 
at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070981.pdf.
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     Uncomplicated Gonorrhea;
     Complicated Intra-Abdominal Infection (draft issued 
September 28, 2012); \3\
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    \3\ Complicated Intra-Abdominal Infection Draft Guidance 
available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM321390.pdf.
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     Diabetic Foot Infection; and
     Hospital-Acquired and Ventilator-Associated Bacterial 
Pneumonia (draft issued November 26, 2010).\4\
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    \4\ Hospital Acquired and Ventilator Associated Pneumonia Draft 
Guidance available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM234907.pdf.
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IV. Emerging Resistance to Antibacterial Drugs

    In addition to facilitating antibacterial drug development, the 
task force recognizes the need to address the issue of emerging drug 
resistance. The public health need caused by the lack of a robust 
pipeline is further compounded by the diminishing effectiveness of 
currently available antibacterial drugs due to emerging drug 
resistance. Therefore, we are seeking comment on strategies to preserve 
the utility of antibacterial drugs.

V. Categories for Public Comment

    We request the following information from the public:
     Novel study designs to expedite the development of new 
antibacterial drugs;
     Comments on our prioritized list of proposed draft or 
final guidance development; and
     Potential strategies intended to slow the rate of emerging 
drug resistance.
    When responding to this notice, please include the category or 
categories that your response addresses.

VI. Comments

    Interested persons may submit either electronic comments to http://www.regulations.gov or written comments regarding this document to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. When responding, 
include the category or categories that your response addresses as 
listed in section V of this document. Received comments may be seen in 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: May 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-12925 Filed 5-30-13; 8:45 am]
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