
[Federal Register Volume 81, Number 166 (Friday, August 26, 2016)]
[Notices]
[Pages 58941-58942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20473]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0408]


Microbiology Data for Systemic Antibacterial Drugs--Development, 
Analysis, and Presentation; 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 ``Microbiology 
Data for Systemic Antibacterial Drugs--Development, Analysis, and 
Presentation.'' The purpose of this guidance is to assist sponsors in 
the development, analysis, and presentation of microbiology data during 
antibacterial drug development. This guidance finalizes the draft 
guidance of the same name issued on September 17, 2009.

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: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2009-D-0408 for ``Microbiology Data for Systemic Antibacterial 
Drugs--Development, Analysis, and Presentation; Guidance for Industry; 
Availability.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 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-
796-1400.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Microbiology Data for Systemic Antibacterial Drugs--
Development, Analysis, and Presentation.'' The purpose of this guidance 
is to assist sponsors in the development, analysis, and presentation of 
microbiology data during antibacterial drug development. Microbiology 
data provide important information to guide clinical development of 
antibacterial drugs and guide clinicians on the use of an antibacterial 
drug for its intended indication.
    This guidance finalizes the draft guidance issued on September 17, 
2009

[[Page 58942]]

(74 FR 47804). After consideration of comments received in response to 
the draft guidance, the guidance was restructured to describe general 
approaches to microbiology data collection in the body of the guidance 
and to provide more specific recommendations in appendixes (e.g., the 
format for microbiology data presentation and an example for sections 
of labeling that pertain to microbiology).
    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 the development, analysis, and presentation 
of microbiology data for systemic antibacterial drugs. 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.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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).
    1. This guidance provides recommendations on the type of 
information to include in submissions of the clinical microbiology 
section of investigational new drug applications (INDs) and new drug 
applications (NDAs) for systemic antibacterial drugs. The microbiology 
section of an NDA is required under 21 CFR 314.50(d)(4) and this 
information collection is approved under OMB control number 0910-0001. 
For INDs, this information is required under 21 CFR 312.23(a) and 
approved under OMB control number 0910-0014.
    2. This guidance also recommends the types of data that should be 
submitted in a labeling supplement to update the microbiology 
information in approved labeling if an application holder chooses to 
update this information without relying on a standard recognized by 
FDA. The submission of labeling supplements is required under 21 CFR 
314.70(b)(2)(v) and 201.56(a)(2) and this information collection is 
approved under OMB control numbers 0910-0001 and 0910-0572, 
respectively.
    3. Appendix D of this guidance describes the content of the 
Microbiology subsection of labeling. This labeling is covered under 21 
CFR 201.57(c)(13)(i) and the information collection is approved under 
OMB control number 0910-0572.
    4. This guidance also references the guidance for industry entitled 
``Updating Labeling for Susceptibility Test Information in Systemic 
Antibacterial Drug Products and Antimicrobial Susceptibility Testing 
Devices'' for updating labeling information. The information collection 
in this guidance has been approved under OMB control number 0910-0638.

III. Electronic Access

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

    Dated: August 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-20473 Filed 8-25-16; 8:45 am]
 BILLING CODE 4164-01-P


