[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 This guidance finalizes the draft
guidance of the same name issued on September 17, 2009.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