National Advisory Council on the National Health Service Corps; Notice of Meeting, 39738 [2013-15713]
Download as PDF
<![CDATA[
tkelley on DSK3SPTVN1PROD with NOTICES
39738
Federal Register / Vol. 78, No. 127 / Tuesday, July 2, 2013 / Notices
have a narrow spectrum of activity or
are only active against a single genus or
species of bacteria).
Efforts to develop new antibacterial
drugs have diminished in the past few
decades. Because bacteria continue to
develop resistance to available
antibacterial drugs, an increasing
number of patients are suffering from
bacterial diseases that do not respond to
currently available antibacterial drugs
and therefore have unmet medical needs
for antibacterial therapy. To foster new
antibacterial drug development that will
have the potential to keep pace with
continued pressures leading to
antibacterial resistance, FDA is
exploring approaches to help streamline
development programs for new
antibacterial drugs. This effort is
intended not only to spur development
of new drugs for populations with
infections caused by resistant
organisms, but also to facilitate
development of drugs for broad
indications that are associated with
other unmet medical needs. In addition,
the draft guidance outlines development
approaches for pathogen-focused
antibacterial drugs (i.e., drugs that have
a narrow spectrum of activity or are
only active against a single genus and
species of bacteria).
This draft guidance describes some
examples of approaches that may be
used by sponsors as part of streamlined
development programs. Some of these
approaches are not novel, but are
included to provide examples of various
ways of collecting the evidence needed
to demonstrate safety and efficacy to
address unmet medical needs. FDA is
inviting proposals for other innovative
approaches that should be considered,
particularly for infections caused by
resistant organisms. FDA is interested in
approaches such as using information
from other sites of infection; pooling
data from various sites; additional
endpoints; an increased emphasis on
the use of animal data to complement
clinical data; or any other approaches
that may be used to generate reliable
evidence of efficacy.
As part of FDA’s efforts to facilitate
the development of antibacterial drugs
for serious or life-threatening bacterial
infections, particularly in areas of
unmet need, this draft guidance
specifies how nonclinical and clinical
data can be used to inform an efficient
and streamlined pathogen-focused
antibacterial drug development program
and provides advice on approaches for
the development of antibacterial drugs
that target a more limited spectrum of
pathogens. As such, it is intended to
fulfill the requirement in section 806(a),
Title VIII (entitled ‘‘Generating
VerDate Mar<15>2010
16:48 Jul 01, 2013
Jkt 229001
Antibiotic Incentives Now’’), of the
Food and Drug Administration Safety
and Innovation Act of 2012 (FDASIA)
(Pub. L. 112–144), to publish a draft
guidance on pathogen-focused
antibacterial drug development. After
consideration of comments submitted in
response to this draft guidance, FDA
intends to begin work on finalizing the
guidance, as required by section 806(b)
of FDASIA.
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 Agency’s current thinking
on this topic. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. The Paperwork Reduction Act of
1995
This draft 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
part 312 and 21 part CFR 314 have been
approved under OMB control numbers
0910–0014 and 0910–0001, respectively.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: June 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–15783 Filed 7–1–13; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Council on the
National Health Service Corps; Notice
of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Public Law 92–463), notice is hereby
given of the following meeting:
Name: National Advisory Council on
the National Health Service Corps
(NHSC)
Date and Time: July 18, 2013—
2:00pm–3:30pm ET
Place: The meeting will be via audio
conference call.
Status: The meeting will be open to
the public.
Agenda: The Council is holding a
meeting via conference call to discuss
the Affordable Care Act, NHSC retention
resources, and partnerships. The public
can join the meeting via audio
conference call on the date and time
specified above using the following
information: Dial-in number: 1–800–
857–5081; Passcode: 1060359. There
will be an opportunity for the public to
comment towards the end of the call.
FOR FURTHER INFORMATION CONTACT:
Njeri Jones, Bureau of Clinician
Recruitment and Service, Health
Resources and Services Administration,
Parklawn Building, Room 13–64, 5600
Fishers Lane, Rockville, MD 20857;
email: NJones@hrsa.gov; telephone:
301–443–2541.
Dated: June 25, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–15713 Filed 7–1–13; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Council on Nurse
Education and Practice; Notice for
Request for Nominations
The Health Resources and
Services Administration (HRSA) is
requesting nominations to fill seven
vacancies on the National Advisory
Council on Nurse Education and
Practice (NACNEP).
SUMMARY:
Authority: The National Advisory Council
on Nurse Education and Practice is in
accordance with the provisions of 42 United
E:\FR\FM\02JYN1.SGM
02JYN1
]]>Agencies
[Federal Register Volume 78, Number 127 (Tuesday, July 2, 2013)]
[Notices]
[Page 39738]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15713]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Advisory Council on the National Health Service Corps;
Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Public Law 92-463), notice is hereby given of the
following meeting:
Name: National Advisory Council on the National Health Service
Corps (NHSC)
Date and Time: July 18, 2013--2:00pm-3:30pm ET
Place: The meeting will be via audio conference call.
Status: The meeting will be open to the public.
Agenda: The Council is holding a meeting via conference call to
discuss the Affordable Care Act, NHSC retention resources, and
partnerships. The public can join the meeting via audio conference call
on the date and time specified above using the following information:
Dial-in number: 1-800-857-5081; Passcode: 1060359. There will be an
opportunity for the public to comment towards the end of the call.
FOR FURTHER INFORMATION CONTACT: Njeri Jones, Bureau of Clinician
Recruitment and Service, Health Resources and Services Administration,
Parklawn Building, Room 13-64, 5600 Fishers Lane, Rockville, MD 20857;
email: NJones@hrsa.gov; telephone: 301-443-2541.
Dated: June 25, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-15713 Filed 7-1-13; 8:45 am]
BILLING CODE 4165-15-P
