
[Federal Register Volume 78, Number 127 (Tuesday, July 2, 2013)]
[Notices]
[Pages 39737-39738]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15783]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0744]


Draft Guidance for Industry on Antibacterial Therapies for 
Patients With Unmet Medical Need for the Treatment of Serious Bacterial 
Diseases; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Antibacterial 
Therapies for Patients With Unmet Medical Need for the Treatment of 
Serious Bacterial Diseases.'' The purpose of the draft guidance is to 
assist sponsors in the development of new antibacterial drugs to treat 
serious bacterial diseases, particularly in areas of unmet need, and 
new antibacterial drugs that are pathogen-focused (i.e., drugs that 
have a narrow spectrum of activity or are only active against a single 
genus or species of bacteria).

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 30, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Joseph G. Toerner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave, Bldg. 22, Rm. 6244, Silver Spring, MD 20993-0002, 301-
796-1300.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Antibacterial Therapies for Patients With Unmet Medical Need 
for the Treatment of Serious Bacterial Diseases.'' The purpose of this 
draft guidance is to assist sponsors in the development of new 
antibacterial drugs for the treatment of serious bacterial diseases in 
patients with unmet medical needs and new antibacterial drugs that are 
pathogen-focused (i.e., drugs that

[[Page 39738]]

have a narrow spectrum of activity or are only active against a single 
genus or species of bacteria).
    Efforts to develop new antibacterial drugs have diminished in the 
past few decades. Because bacteria continue to develop resistance to 
available antibacterial drugs, an increasing number of patients are 
suffering from bacterial diseases that do not respond to currently 
available antibacterial drugs and therefore have unmet medical needs 
for antibacterial therapy. To foster new antibacterial drug development 
that will have the potential to keep pace with continued pressures 
leading to antibacterial resistance, FDA is exploring approaches to 
help streamline development programs for new antibacterial drugs. This 
effort is intended not only to spur development of new drugs for 
populations with infections caused by resistant organisms, but also to 
facilitate development of drugs for broad indications that are 
associated with other unmet medical needs. In addition, the draft 
guidance outlines development approaches for pathogen-focused 
antibacterial drugs (i.e., drugs that have a narrow spectrum of 
activity or are only active against a single genus and species of 
bacteria).
    This draft guidance describes some examples of approaches that may 
be used by sponsors as part of streamlined development programs. Some 
of these approaches are not novel, but are included to provide examples 
of various ways of collecting the evidence needed to demonstrate safety 
and efficacy to address unmet medical needs. FDA is inviting proposals 
for other innovative approaches that should be considered, particularly 
for infections caused by resistant organisms. FDA is interested in 
approaches such as using information from other sites of infection; 
pooling data from various sites; additional endpoints; an increased 
emphasis on the use of animal data to complement clinical data; or any 
other approaches that may be used to generate reliable evidence of 
efficacy.
    As part of FDA's efforts to facilitate the development of 
antibacterial drugs for serious or life-threatening bacterial 
infections, particularly in areas of unmet need, this draft guidance 
specifies how nonclinical and clinical data can be used to inform an 
efficient and streamlined pathogen-focused antibacterial drug 
development program and provides advice on approaches for the 
development of antibacterial drugs that target a more limited spectrum 
of pathogens. As such, it is intended to fulfill the requirement in 
section 806(a), Title VIII (entitled ``Generating Antibiotic Incentives 
Now''), of the Food and Drug Administration Safety and Innovation Act 
of 2012 (FDASIA) (Pub. L. 112-144), to publish a draft guidance on 
pathogen-focused antibacterial drug development. After consideration of 
comments submitted in response to this draft guidance, FDA intends to 
begin work on finalizing the guidance, as required by section 806(b) of 
FDASIA.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on this topic. 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative approach may be 
used if such approach satisfies the requirements of the applicable 
statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 312 and 21 part 
CFR 314 have been approved under OMB control numbers 0910-0014 and 
0910-0001, respectively.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments 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. 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: June 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-15783 Filed 7-1-13; 8:45 am]
BILLING CODE 4160-01-P


