82 FR 35973 - Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 147 (August 2, 2017)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases.'' The purpose of the guidance is to assist sponsors in the development of new antibacterial drugs to treat serious bacterial diseases in patients with an unmet medical need, including patients who have a serious bacterial disease for which effective antibacterial drugs are limited or lacking. This guidance finalizes the draft guidance of the same name issued July 2, 2013.

[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)]
[Notices]
[Pages 35973-35974]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-16228]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Antibacterial 
Therapies for Patients With an Unmet Medical Need for the Treatment of 
Serious Bacterial Diseases.'' The purpose of the guidance is to assist 
sponsors in the development of new antibacterial drugs to treat serious 
bacterial diseases in patients with an unmet medical need, including 
patients who have a serious bacterial disease for which effective 
antibacterial drugs are limited or lacking. This guidance finalizes the 
draft guidance of the same name issued July 2, 2013.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-D-0744 for ``Antibacterial Therapies for Patients With an 
Unmet Medical Need for the Treatment of Serious Bacterial Diseases.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building., 4th Floor, 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 guidance document.

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 guidance for industry 
entitled ``Antibacterial Therapies for Patients With an Unmet Medical 
Need for the Treatment of Serious Bacterial Diseases.'' The purpose of 
this guidance is to assist sponsors in the development of new 
antibacterial drugs for the treatment of serious bacterial diseases in 
patients with an unmet medical need, including patients who have a 
serious bacterial disease for which effective antibacterial drugs are 
limited or lacking.
    Efforts to develop new antibacterial drugs have diminished in the 
past few decades. Because bacteria continue to develop resistance to 
available antibacterial drugs, a situation of unmet medical need has 
arisen in which patients with serious bacterial diseases have limited 
or in some cases no alternative antibacterial drugs available for 
treatment. To foster new antibacterial drug development that will have 
the potential to keep pace with continued selective pressures of 
antibacterial resistance, FDA is exploring approaches to help 
streamline development programs for new

[[Page 35974]]

antibacterial drugs. This guidance outlines approaches for streamlined 
development programs that are consistent with FDA's longstanding 
commitment to regulatory flexibility regarding the evidence required to 
support drug approval for patient populations with serious disease and 
limited or no treatment options, while meeting appropriate standards 
for safety and effectiveness (see, for example, 21 CFR 312, subpart E, 
Drugs Intended to Treat Life-threatening and Severely-debilitating 
Illnesses).
    This guidance finalizes the draft guidance of the same name issued 
July 2, 2013 (78 FR 39737). After consideration of comments received in 
response to the draft guidance, FDA updated the guidance to include 
clarifications about trial designs for streamlined development programs 
and statistical approaches. In addition, the guidance outlines 
development approaches for antibacterial drugs that are pathogen-
focused (i.e., drugs that are intended to treat a single species or a 
few species of bacteria) and, accordingly, fulfills the requirements of 
section 806(a), Title VIII (entitled ``Generating Antibiotic Incentives 
Now'') of the Food and Drug Administration Safety and Innovation Act 
(Pub. L. 112-144).
    FDA notes that section 3042 of the 21st Century Cures Act (Pub. L. 
114-255), which establishes a limited population pathway for certain 
antibacterial and antifungal drugs (LPAD) that are intended to treat a 
serious or life-threatening infection in a limited population of 
patients with unmet needs, was enacted shortly before publication of 
this guidance. Some antibacterial drugs that are candidates for a 
streamlined development program may also be candidates for LPAD. FDA 
intends to issue separate guidance regarding LPAD. Sponsors are 
encouraged to discuss proposed approaches with the Division of Anti-
Infective Products.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on this topic. It does not establish any rights 
for any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations. This is not a significant regulatory action 
subject to Executive Order 12866.

II. The Paperwork Reduction Act of 1995

    This 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 parts 312 and 314 have 
been approved under OMB control numbers 0910-0014 and 0910-0001, 
respectively.

III. Electronic Access

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

    Dated: July 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16228 Filed 8-1-17; 8:45 am]
BILLING CODE 4164-01-P