National Advisory Council on Nurse Education and Practice; Notice for Request for Nominations, 39738-39739 [2013-15711]
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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the draft guidance outlines development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This draft guidance describes some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unmet need, this draft guidance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
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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]
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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
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Federal Register / Vol. 78, No. 127 / Tuesday, July 2, 2013 / Notices
States Code (U.S.C.) 297t; Section 845 of the
Public Health Service Act, as amended. The
Council is governed by provisions of Public
Law 92–463, which sets forth standards for
the formation and use of advisory
committees.
The Agency must receive
nominations on or before September 5,
2013.
ADDRESSES: All nominations are to be
submitted either by mail or email to
CDR Serina A. Hunter-Thomas,
Designated Federal Official, NACNEP,
Division of Nursing, Bureau of Health
Professions (BHPr), Health Resources
and Administration (HRSA), Parklawn
Building, Room 9–61, 5600 Fishers
Lane, Rockville, MD 20857. CDR
Hunter-Thomas’ email address is:
SHunter-Thomas@Hrsa.gov.
FOR FURTHER INFORMATION CONTACT: For
additional information, please contact
CDR Hunter-Thomas by email or
telephone at (301) 443–4499. A copy of
the current committee membership,
charter, and reports can be obtained by
accessing the NACNEP Web site at
https://bhpr.hrsa.gov/nursing/
nacnep.htm.
SUPPLEMENTARY INFORMATION: Under the
authorities that established the NACNEP
and the Federal Advisory Committee
Act, HRSA is requesting nominations
for seven new committee members. The
NACNEP advises and makes
recommendations to the Secretary and
Congress on policy matters arising in
the administration of Title VIII
including the range of issues relating to
the nurse workforce, nursing education,
and nursing practice improvement. The
Advisory Committee may make specific
recommendations to the Secretary and
Congress regarding programs
administered by the Division of
Nursing, Bureau of Health Professions,
Health Resources and Services
Administration, particularly within the
context of the enabling legislation and
the Division’s mission and strategic
directions, as a means of enhancing the
health of the public through the
development of the nursing workforce.
The Advisory Committee provides
advice to the Secretary and Congress in
preparation of general regulations and
with respect to policy matters in the
administration of this Title including
the range of issues relating to the nurse
supply, education, and practice
improvement. The Advisory Council
shall annually prepare and submit to the
Secretary; the Committee on Health,
Education, Labor, and Pensions of the
Senate; and the Committee on Energy
and Commerce of the House of
Representatives, a report describing the
activities of the Advisory Council
tkelley on DSK3SPTVN1PROD with NOTICES
DATES:
VerDate Mar<15>2010
16:48 Jul 01, 2013
Jkt 229001
including its findings and
recommendations.
The Department of Health and Human
Services is requesting a total of seven
nominations for members of the
NACNEP who are full-time students
representing various levels of education
in schools of nursing (i.e. both
undergraduate and graduate); from the
general public; from practicing
professional nurses; from among the
leading authorities in the various fields
of nursing, higher secondary education,
and associate degree schools of nursing;
and from representatives of advanced
education nursing groups (such as nurse
practitioners, nurse midwives, and
nurse anesthetists), hospitals, and other
institutions and organizations which
provide nursing services. The majority
of members shall be nurses.
HRSA has special interest in the
legislative requirements of having a fair
balance between the nursing profession,
including a broad geographic
representation of members from urban
and rural communities, and minorities.
HRSA encourages nominations from
qualified candidates from these groups,
as well as individuals with disabilities
and veterans. Interested persons may
nominate one or more qualified persons
for membership. Self-nominations are
also accepted. Nominations must be
typewritten. The following information
should be included in the package of
materials submitted for each individual
being nominated: (1) A letter of
nomination that clearly states the name
and affiliation of the nominee, the basis
for the nomination (i.e., specific
attributes that qualify the nominee for
services in this capacity as described
above), a statement that the nominee is
willing to serve as a member of
NACNEP and appears to have no
conflict of interest that would preclude
this Committee membership. Potential
candidates will be asked to provide
detailed information concerning such
matters as financial holdings,
consultancies, research grants, and/or
contracts to permit an evaluation of
possible sources of conflicts of interest;
and (2) the nominator’s name, address,
and daytime telephone number; the
home/or work address, and telephone
number; and email address of the
individual being nominated. HRSA
requests inclusion of a current copy of
the nominee’s curriculum vitae and a
statement of interest from the nominee
to support experience working with
Title VIII nursing programs; expertise in
the field; and a personal desire in
participating on a National Advisory
Committee.
Committee members are classified as
Special Government Employees (SGE).
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39739
All SGEs on committees must submit an
annual Form OGE 450 Confidential
Financial Disclosure Report to the
HRSA Ethics Program for analysis using
the Ethics statutes, regulations, and
policies to which all SGEs must adhere.
Members will receive a stipend for each
official meeting day of the Committee,
as well as per diem and travel expenses
as authorized by section 5 U.S.C. 5703
for persons employed intermittently in
Government service.
Appointments shall be made without
discrimination on the basis of age,
ethnicity, gender, sexual orientation,
and cultural, religious, or
socioeconomic status. Qualified
candidates will be invited to serve a 4year term.
Dated: June 25, 2013.
Bahar Niakan,
Director, Division of Policy Review and
Coordination.
[FR Doc. 2013–15711 Filed 7–1–13; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Environmental Health
Sciences Review Committee.
Date: July 24–26, 2013.
Time: 8:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: DoubleTree by Hilton, Ballroom,
4810 Page Creek Lane, Durham, NC 27703.
Contact Person: Linda K Bass, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, National Institute of Environmental
Health Sciences, P.O. Box 12233, MD EC–30,
Research Triangle Park, NC 27709, (919) 541–
1307.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
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]]>Agencies
[Federal Register Volume 78, Number 127 (Tuesday, July 2, 2013)]
[Notices]
[Pages 39738-39739]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15711]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Advisory Council on Nurse Education and Practice; Notice
for Request for Nominations
SUMMARY: 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).
Authority: The National Advisory Council on Nurse Education and
Practice is in accordance with the provisions of 42 United
[[Page 39739]]
States Code (U.S.C.) 297t; Section 845 of the Public Health Service
Act, as amended. The Council is governed by provisions of Public Law
92-463, which sets forth standards for the formation and use of
advisory committees.
DATES: The Agency must receive nominations on or before September 5,
2013.
ADDRESSES: All nominations are to be submitted either by mail or email
to CDR Serina A. Hunter-Thomas, Designated Federal Official, NACNEP,
Division of Nursing, Bureau of Health Professions (BHPr), Health
Resources and Administration (HRSA), Parklawn Building, Room 9-61, 5600
Fishers Lane, Rockville, MD 20857. CDR Hunter-Thomas' email address is:
SHunter-Thomas@Hrsa.gov.
FOR FURTHER INFORMATION CONTACT: For additional information, please
contact CDR Hunter-Thomas by email or telephone at (301) 443-4499. A
copy of the current committee membership, charter, and reports can be
obtained by accessing the NACNEP Web site at https://bhpr.hrsa.gov/nursing/nacnep.htm.
SUPPLEMENTARY INFORMATION: Under the authorities that established the
NACNEP and the Federal Advisory Committee Act, HRSA is requesting
nominations for seven new committee members. The NACNEP advises and
makes recommendations to the Secretary and Congress on policy matters
arising in the administration of Title VIII including the range of
issues relating to the nurse workforce, nursing education, and nursing
practice improvement. The Advisory Committee may make specific
recommendations to the Secretary and Congress regarding programs
administered by the Division of Nursing, Bureau of Health Professions,
Health Resources and Services Administration, particularly within the
context of the enabling legislation and the Division's mission and
strategic directions, as a means of enhancing the health of the public
through the development of the nursing workforce. The Advisory
Committee provides advice to the Secretary and Congress in preparation
of general regulations and with respect to policy matters in the
administration of this Title including the range of issues relating to
the nurse supply, education, and practice improvement. The Advisory
Council shall annually prepare and submit to the Secretary; the
Committee on Health, Education, Labor, and Pensions of the Senate; and
the Committee on Energy and Commerce of the House of Representatives, a
report describing the activities of the Advisory Council including its
findings and recommendations.
The Department of Health and Human Services is requesting a total
of seven nominations for members of the NACNEP who are full-time
students representing various levels of education in schools of nursing
(i.e. both undergraduate and graduate); from the general public; from
practicing professional nurses; from among the leading authorities in
the various fields of nursing, higher secondary education, and
associate degree schools of nursing; and from representatives of
advanced education nursing groups (such as nurse practitioners, nurse
midwives, and nurse anesthetists), hospitals, and other institutions
and organizations which provide nursing services. The majority of
members shall be nurses.
HRSA has special interest in the legislative requirements of having
a fair balance between the nursing profession, including a broad
geographic representation of members from urban and rural communities,
and minorities. HRSA encourages nominations from qualified candidates
from these groups, as well as individuals with disabilities and
veterans. Interested persons may nominate one or more qualified persons
for membership. Self-nominations are also accepted. Nominations must be
typewritten. The following information should be included in the
package of materials submitted for each individual being nominated: (1)
A letter of nomination that clearly states the name and affiliation of
the nominee, the basis for the nomination (i.e., specific attributes
that qualify the nominee for services in this capacity as described
above), a statement that the nominee is willing to serve as a member of
NACNEP and appears to have no conflict of interest that would preclude
this Committee membership. Potential candidates will be asked to
provide detailed information concerning such matters as financial
holdings, consultancies, research grants, and/or contracts to permit an
evaluation of possible sources of conflicts of interest; and (2) the
nominator's name, address, and daytime telephone number; the home/or
work address, and telephone number; and email address of the individual
being nominated. HRSA requests inclusion of a current copy of the
nominee's curriculum vitae and a statement of interest from the nominee
to support experience working with Title VIII nursing programs;
expertise in the field; and a personal desire in participating on a
National Advisory Committee.
Committee members are classified as Special Government Employees
(SGE). All SGEs on committees must submit an annual Form OGE 450
Confidential Financial Disclosure Report to the HRSA Ethics Program for
analysis using the Ethics statutes, regulations, and policies to which
all SGEs must adhere. Members will receive a stipend for each official
meeting day of the Committee, as well as per diem and travel expenses
as authorized by section 5 U.S.C. 5703 for persons employed
intermittently in Government service.
Appointments shall be made without discrimination on the basis of
age, ethnicity, gender, sexual orientation, and cultural, religious, or
socioeconomic status. Qualified candidates will be invited to serve a
4-year term.
Dated: June 25, 2013.
Bahar Niakan,
Director, Division of Policy Review and Coordination.
[FR Doc. 2013-15711 Filed 7-1-13; 8:45 am]
BILLING CODE 4165-15-P
