83 FR 21784 - Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 91 (May 10, 2018)

Page Range		21784-21785
FR Document		2018-09929

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the development of new drugs for the treatment of uncomplicated urinary tract infections.

Federal Register, Volume 83 Issue 91 (Thursday, May 10, 2018)

[Federal Register Volume 83, Number 91 (Thursday, May 10, 2018)]
[Notices]
[Pages 21784-21785]
From the Federal Register Online [www.thefederalregister.org]
[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Treatment; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled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 The purpose of this draft guidance is to assist sponsors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DATES: Submit either electronic or written comments on the draft
guidance by August 8, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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.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.
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

Federal Register / Vol. 83, No. 91 / Thursday, May 10, 2018 / Notices 21785

Treatment.’’ The purpose of this draft II. The Paperwork Reduction Act of at http://www.hhs.gov/nvpo/nvac/
guidance is to assist sponsors in the 1995 meetings/index.html.
development of new drugs for the This guidance refers to previously FOR FURTHER INFORMATION CONTACT:
treatment of uncomplicated urinary approved collections of information that Captain Angela Shen, National Vaccine
tract infections. are subject to review by the Office of Program Office, U.S. Department of
This draft guidance defines Management and Budget (OMB) under Health and Human Services, Room
enrollment criteria for uncomplicated the Paperwork Reduction Act of 1995 715H, Hubert H. Humphrey Building,
urinary tract infection trials and (44 U.S.C. 3501–3520). The collections 200 Independence Avenue SW,
provides options for clinical trials of information in 21 CFR parts 312 and Washington, DC 20201. Phone: (202)
designed to demonstrate efficacy. An 314 have been approved under OMB 690–5566; email: nvac@hhs.gov.
appendix to this draft guidance control numbers 0910–0014 and 0910–
0001, respectively. SUPPLEMENTARY INFORMATION: Pursuant
describes the justification for the to Section 2101 of the Public Health
noninferiority margin to be used for the III. Electronic Access Service Act (42 U.S.C. 300aa–1), the
option of active-controlled trials Persons with access to the internet Secretary of HHS was mandated to
designed to demonstrate noninferiority. may obtain the draft guidance at either establish the National Vaccine Program
In addition, this draft guidance reflects https://www.fda.gov/Drugs/ to achieve optimal prevention of human
recent developments in scientific GuidanceComplianceRegulatory infectious diseases through
information that pertain to drugs being Information/Guidances/default.htm or immunization and to achieve optimal
developed for the treatment of https://www.regulations.gov. prevention against adverse reactions to
uncomplicated urinary tract infections. Dated: May 4, 2018. vaccines. The NVAC was established to
Issuance of this draft guidance fulfills Leslie Kux, provide advice and make
a portion of the requirements of Title recommendations to the Director of the
Associate Commissioner for Policy.
VIII, section 804, of the Food and Drug National Vaccine Program on matters
[FR Doc. 2018–09929 Filed 5–9–18; 8:45 am]
Administration Safety and Innovation related to the Program’s responsibilities.
BILLING CODE 4164–01–P
Act (Pub. L. 112–144), which requires The Assistant Secretary for Health
FDA to review and, as appropriate, serves as Director of the National
revise not fewer than three guidance DEPARTMENT OF HEALTH AND Vaccine Program.
documents per year for the conduct of HUMAN SERVICES The public meeting will include a
clinical trials with respect to presentation from the HPV
antibacterial and antifungal drugs. In Meeting of the National Vaccine Implementation Working Group on its
1998, FDA published a draft guidance Advisory Committee findings and draft recommendations for
entitled ‘‘Uncomplicated Urinary Tract AGENCY: National Vaccine Program strengthening the effectiveness of
Infections—Developing Antimicrobial Office, Office of the Assistant Secretary national, state, and local efforts to
Drugs for Treatment’’ (the 1998 draft for Health, Office of the Secretary, improve HPV coverage rates. The
guidance). In a Federal Register notice Department of Health and Human presentation will be followed by
dated August 7, 2013 (78 FR 48175), Services. Committee deliberation and a vote. The
FDA announced an initiative in the public meeting will also include a
ACTION: Notice.
Center for Drug Evaluation and Research presentation on the recent HHS report,
involving the review of draft guidance SUMMARY: As stipulated by the Federal ‘‘Encouraging Vaccine Innovation:
documents issued before 2010 to Advisory Committee Act, the Promoting the Development of Vaccines
Department of Health and Human that Minimize the Burden of Infectious
determine their status and to decide
Services (HHS) is hereby giving notice Diseases in the 21st Century,’’ which
whether those guidances should be
that a meeting is scheduled to be held was submitted to Congress in
withdrawn, revised, or finalized with
of the National Vaccine Advisory accordance with provisions in the 21st
only minor changes. In the same August
Committee (NVAC). The meeting will be Century Cures Act. All agenda items are
7, 2013, Federal Register notice, FDA tentative and subject to change.
open to the public via teleconference; a
announced that the 1998 draft guidance, Information on the final meeting agenda
public comment session will be held
as well as other draft guidances, was will be posted prior to the meeting on
during the meeting.
being withdrawn (78 FR 48175). FDA is the NVAC website: http://www.hhs.gov/
DATES: The meeting will be held on June
now issuing a new draft guidance that nvpo/nvac/index.html.
revises the recommendations in the 25, 2018, from 2:00 p.m. to 4:30 p.m.
EST. The confirmed meeting times and Members of the public will have the
1998 draft guidance.
agenda will be posted on the NVAC opportunity to provide comments at the
This draft guidance is being issued website at http://www.hhs.gov/nvpo/ NVAC meeting during the public
consistent with FDA’s good guidance nvac/meetings/index.html as soon as comment periods designated on the
practices regulation (21 CFR 10.115). they become available. agenda. Public comments made during
The draft guidance, when finalized, will ADDRESSES: Instructions regarding the meeting will be limited to three
represent the current thinking of FDA attending this meeting will be posted minutes per person to ensure time is
on developing drugs for the treatment of one week prior to the meeting at: http:// allotted for all those wishing to speak.
uncomplicated urinary tract infections. www.hhs.gov/nvpo/nvac/meetings/ Individuals are also welcome to submit
daltland on DSKBBV9HB2PROD with NOTICES

It does not establish any rights for any index.html. Pre-registration is required their written comments. Written
person and is not binding on FDA or the for members of the public who wish to comments should not exceed three
public. You can use an alternative attend the meeting and who wish to pages in length. Individuals submitting
approach if it satisfies the requirements participate in the public comment written comments should email their
of the applicable statutes and session. Individuals who wish to attend comments to the National Vaccine
regulations. This guidance is not subject the meeting and/or participate in the Program Office (nvac@hhs.gov) at least
to Executive Order 12866. public comment session should register five business days prior to the meeting.

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Document Created: 2018-11-02 09:47:25
Document Modified: 2018-11-02 09:47:25

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
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.
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.
FR Citation		83 FR 21784

83 FR 21784 - Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 91 (May 10, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration