[Federal Register Volume 83, Number 91 (Thursday, May 10, 2018)]
[Notices]
[Pages 21784-21785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09929]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1562]


Uncomplicated Urinary Tract Infections: Developing Drugs for 
Treatment; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled 
``Uncomplicated Urinary Tract Infections: Developing Drugs for 
Treatment.'' The purpose of this draft guidance is to assist sponsors 
in the development of new drugs for the treatment of uncomplicated 
urinary tract infections.

DATES: Submit either electronic or written comments on the draft 
guidance by August 8, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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-2018-D-1562 for ``Uncomplicated Urinary Tract Infections: 
Developing Drugs for Treatment; Draft Guidance for Industry.'' 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.gpo.gov/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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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, 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Joseph 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 draft guidance for industry 
entitled ``Uncomplicated Urinary Tract Infections: Developing Drugs for

[[Page 21785]]

Treatment.'' The purpose of this draft guidance is to assist sponsors 
in the development of new drugs for the treatment of uncomplicated 
urinary tract infections.
    This draft guidance defines enrollment criteria for uncomplicated 
urinary tract infection trials and provides options for clinical trials 
designed to demonstrate efficacy. An appendix to this draft guidance 
describes the justification for the noninferiority margin to be used 
for the option of active-controlled trials designed to demonstrate 
noninferiority. In addition, this draft guidance reflects recent 
developments in scientific information that pertain to drugs being 
developed for the treatment of uncomplicated urinary tract infections.
    Issuance of this draft guidance fulfills a portion of the 
requirements of Title VIII, section 804, of the Food and Drug 
Administration Safety and Innovation Act (Pub. L. 112-144), which 
requires FDA to review and, as appropriate, revise not fewer than three 
guidance documents per year for the conduct of clinical trials with 
respect to antibacterial and antifungal drugs. In 1998, FDA published a 
draft guidance entitled ``Uncomplicated Urinary Tract Infections--
Developing Antimicrobial Drugs for Treatment'' (the 1998 draft 
guidance). In a Federal Register notice dated August 7, 2013 (78 FR 
48175), FDA announced an initiative in the Center for Drug Evaluation 
and Research involving the review of draft guidance documents issued 
before 2010 to determine their status and to decide whether those 
guidances should be withdrawn, revised, or finalized with only minor 
changes. In the same August 7, 2013, Federal Register notice, FDA 
announced that the 1998 draft guidance, as well as other draft 
guidances, was being withdrawn (78 FR 48175). FDA is now issuing a new 
draft guidance that revises the recommendations in the 1998 draft 
guidance.
    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 current thinking of FDA on developing 
drugs for the treatment of uncomplicated urinary tract infections. 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 guidance 
is not 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 draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: May 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09929 Filed 5-9-18; 8:45 am]
 BILLING CODE 4164-01-P


