Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases; Guidance for Industry; Availability, 35973-35974 [2017-16228]
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Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices
Dated July 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
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’’).
[FR Doc. 2017–16230 Filed 8–1–17; 8:45 am]
BILLING CODE 4164–01–P
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.
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guidance finalizes the draft guidance of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:
sradovich on DSKBCFCHB2PROD with NOTICES
SUMMARY:
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
VerDate Sep<11>2014
19:43 Aug 01, 2017
Jkt 241001
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
PO 00000
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35973
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/201523389.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
E:\FR\FM\02AUN1.SGM
02AUN1
sradovich on DSKBCFCHB2PROD with NOTICES
35974
Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices
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 Severelydebilitating 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 AntiInfective 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
VerDate Sep<11>2014
19:43 Aug 01, 2017
Jkt 241001
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/
GuidanceCompliance
RegulatoryInformation/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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the National Advisory
Committee on Children and Disasters
Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that the National Advisory Committee
on Children and Disasters (NACCD) will
hold a public meeting on September 7,
2017.
DATES: The NACCD meeting is
September 7, 2017, from 3:00 p.m. to
4:00 p.m. EST.
ADDRESSES: We encourage members of
the public to attend the teleconference.
To register, go to https://www.phe.gov/
naccd and click on the Contact Us link
to open the Contact NACCD form, and
then fill out the form with NACCD
Registration in the subject line. Submit
your comments on the NACCD Contact
Form located at https://www.phe.gov/
NACCDComments.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
CDR
Evelyn Seel, (202) 205–7960,
evelyn.seel@hhs.gov. Visit the NACCD
Web site located at https://
www.phe.gov/naccd.
SUPPLEMENTARY INFORMATION: Pursuant
to the Federal Advisory Committee Act
(FACA) of 1972 (5 U.S.C., Appendix, as
amended), and section 2811A of the
Public Health Service (PHS) Act (42
U.S.C. 300hh–10a), as added by section
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103 of the Pandemic and All-Hazards
Preparedness Reauthorization Act of
2013 (Pub. L. 113–5), the HHS
Secretary, in consultation with the
Secretary of the U.S. Department of
Homeland Security, established the
NACCD. The purpose of the NACCD is
to provide advice and consultation to
the HHS Secretary with respect to the
medical and public health needs of
children in relation to disasters.
Background: The NACCD public
meeting on September 7, 2017, is
dedicated to the deliberation and vote
on the Human Services Working Group
Report. We will post modifications to
the agenda on the NACCD September 7,
2017 meeting Web page, which is
located at https://www.phe.gov/naccd.
Availability of Materials: We will post
all meeting materials prior to the
meeting on the NACCD September 7,
2017 meeting Web page located at
https://www.phe.gov/naccd.
Procedures for Providing Public Input:
Members of the public attend by
teleconference via a toll-free call-in
phone number, which is available on
the NACCD Web site at https://
www.phe.gov/naccd.
We encourage members of the public
to provide written comments that are
relevant to the NACCD teleconference
prior to September 7, 2017. Send
written comments by email via the
‘‘Contact Us’’ link on https://
www.phe.gov/naccd with ‘‘NACCD
Public Comment’’ in the subject line.
The NACCD will respond to comments
received by close-of-business September
7, 2017, during the meeting.
Dated: July 13, 2017.
George W. Korch Jr.,
Acting Assistant Secretary for Preparedness
and Response.
[FR Doc. 2017–15853 Filed 8–1–17; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation of Nominations for
Membership on the Secretary’s
Advisory Committee on Human
Research Protections
Office of the Assistant
Secretary for Health, Office for Human
Research Protections, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The Office for Human
Research Protections (OHRP), a program
office in the Office of the Assistant
Secretary for Health, Department of
Health and Human Services (HHS), is
SUMMARY:
E:\FR\FM\02AUN1.SGM
02AUN1
Agencies
[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)]
[Notices]
[Pages 35973-35974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16228]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.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.
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