National Advisory Council on Nurse Education and Practice; Notice of Meeting, 12554-12555 [2010-5675]
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Federal Register / Vol. 75, No. 50 / Tuesday, March 16, 2010 / Notices
Federal Register of August 28, 2009,
requesting comments on this draft PIN.
Sixteen parties, including both
individuals and groups, submitted a
total of 31 comments regarding the draft
PIN. After review and careful
consideration of all comments received,
HRSA has amended the PIN to
incorporate certain recommendations
from the public. The final PIN reflects
these changes.
In addition to making the final PIN
available on HRSA’s Web site, HRSA is
also posting the Agency’s ‘‘Response to
Public Comments.’’ The purpose of that
document is to summarize the major
comments received and describe the
Agency’s response, including any
corresponding changes made to the PIN.
Where comments did not result in a
revision to the PIN, explanations are
provided.
FOR FURTHER INFORMATION CONTACT: For
questions regarding this notice, please
contact the Office of Policy and Program
Development, Bureau of Primary Health
Care, HRSA, at OPPDGeneral@hrsa.gov.
Dated: March 8, 2010.
Mary K. Wakefield,
Administrator.
[FR Doc. 2010–5671 Filed 3–15–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
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Clinical Laboratory Improvement
Advisory Committee: Notice of Charter
Renewal
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that the Clinical
Laboratory Improvement Advisory
Committee, Centers for Disease Control
and Prevention, Department of Health
and Human Services, has been renewed
for a 2-year period through February 19,
2012.
For information, contact Thomas
Hearn, PhD, Designated Federal Officer,
Clinical Laboratory Improvement
Advisory Committee, Centers for
Disease Control and Prevention,
Department of Health and Human
Services, 1600 Clifton Road, NE.,
Mailstop C12, Atlanta, Georgia 30333,
telephone (404) 718–1048 or fax (404)
639–3039.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the CDC
VerDate Nov<24>2008
16:33 Mar 15, 2010
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and the Agency for Toxic Substances
and Disease Registry.
Dated: March 9, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
Dated: March 9, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2010–5628 Filed 3–15–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Centers for Disease Control and
Prevention
National Advisory Council on Nurse
Education and Practice; Notice of
Meeting
Mine Safety and Health Research
Advisory Committee, National Institute
for Occupational Safety and Health
(MSHRAC, NIOSH)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Public Law 92–463), notice is hereby
given of the following meetings:
Name: National Advisory Council on
Nurse Education and Practice
(NACNEP).
Dates and Times: April 22, 2010, 8:30
a.m.–4:30 p.m.
April 23, 2010, 8:30 a.m.–4 p.m.
Place: Doubletree Bethesda Hotel &
Executive Meeting Center, 8120
Wisconsin Avenue, Bethesda, MD
20814.
Status: The meeting will be open to
the public.
Agenda: Agency and Bureau
administrative updates will be
provided.
Purpose: The purpose of this meeting
is to address issues relating to the role
of nursing in primary care and
implications for workforce. The
objectives of the meeting are to: (1)
Delineate the variety of roles nurses
play in primary care including health
promotion, screening, public education,
illness prevention, primary care and
management of stable chronic
conditions; (2) review and evaluate the
data related to education preparation
and supply of primary care nurses and
advanced practice registered nurses; (3)
describe factors that facilitate and
sustain primary care practice by
qualified, competent advanced practice
registered nurses; (4) identify the
financial and regulatory barriers to
effective, accessible primary care
delivered by nurses and recommended
strategies for resolution; and (5) review
and recommend community-based,
nurse-directed models for primary care
delivery that are cost effective and
produce quality outcomes. This meeting
is a continuation of the meeting that was
held November 2009. Experts from
professional nursing, public and private
organizations will make presentations
on primary care delivery models. During
this meeting, the NACNEP council
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting for the
aforementioned committee:
Time and Date: 8:15 a.m.–5 p.m., March
30, 2010; 8 a.m.–11:30 a.m., March 31, 2010.
Place: Hilton Garden Inn Pittsburgh/
Southpointe, 1000 Corporate Drive,
Canonsburg, Pennsylvania 15317, telephone
(724) 743–5000, fax (724) 743–5010.
Status: Open to public, limited only by the
space available. The meeting room
accommodates approximately 50 people.
Purpose: This committee is charged with
providing advice to the Secretary,
Department of Health and Human Services;
the Director, CDC; and the Director, NIOSH,
on priorities in mine safety and health
research, including grants and contracts for
such research, 30 U.S.C. 812(b)(2), Section
102(b)(2).
Matters To Be Discussed: The meeting will
focus on deep cover retreat mining research,
mine illumination research, mine escape and
rescue, human factors research, coal dust
particle size surveys, and updates on
proximity detection, a mine escape vehicle,
robotics research, and results of broad agency
announcements for mining research.
Agenda items are subject to change as
priorities dictate.
For More Information Contact: Jeffery L.
Kohler, PhD, Designated Federal Officer,
MSHRAC, NIOSH, CDC, 626 Cochrans Mill
Road, telephone (412) 386–5301, fax (412)
386–5300.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities for
both CDC and the Agency for Toxic
Substances and Disease Registry.
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Federal Register / Vol. 75, No. 50 / Tuesday, March 16, 2010 / Notices
members will deliberate on the content
presented and formulate
recommendations to the Secretary of
Health and Human Services and the
Congress on the role of nursing in
primary care. This meeting will form the
basis for NACNEP’s mandated Tenth
Annual Report.
The NACNEP will join the Council on
Graduate Medical Education (COGME),
the Advisory Committee on Training in
Primary Care Medicine and Dentistry
(ACTPCMD), and the Advisory
Committee on Interdisciplinary,
Community-Based Linkages (ACICBL)
on April 21, 2010, for the third Bureau
of Health Professions (BHPr) All
Advisory Committee Meeting. Please
refer to the Federal Register notice for
the BHPr All Advisory Committee
Meeting for additional details.
For further information regarding
NACNEP, to obtain a roster of members,
minutes of the meeting, or other
relevant information, contact Lakisha
Smith, Executive Secretary, National
Advisory Council on Nurse Education
and Practice, Parklawn Building, Room
8C–26, 5600 Fishers Lane, Rockville,
Maryland 20857, telephone (301) 443–
5688. Information can also be found at
the following web site: https://
bhpr.hrsa.gov/nursing/nacnep.htm
Dated: March 10, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2010–5675 Filed 3–15–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0128]
Prescription Drug User Fee Act; Public
Meeting
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice of public meeting.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public meeting on the Prescription Drug
User Fee Act (PDUFA). The legislative
authority for PDUFA expires in
September 2012. At that time, new
legislation will be required for FDA to
continue collecting user fees for the
prescription drug program. The Federal
Food, Drug, and Cosmetic Act (FD&C
Act) requires that before FDA begins
negotiations with the regulated industry
on PDUFA reauthorization, we publish
a notice in the Federal Register
requesting public input on the
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16:33 Mar 15, 2010
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reauthorization, hold a public meeting
at which the public may present its
views on the reauthorization, provide a
period of 30 days after the public
meeting to obtain written comments
from the public suggesting changes, and
publish the comments on FDA’s Web
site. FDA invites public comment on the
PDUFA program and suggestions
regarding the features FDA should
propose for the next PDUFA program.
DATES: The public meeting will be held
on April 12, 2010, from 9 a.m. to 5 p.m.
Registration to attend the meeting must
be received by April 5, 2010. See
Section III.C of this document for
information on how to register for the
meeting. Submit written or electronic
comments by May 12, 2010.
ADDRESSES: The meeting will be held at
the Hilton Washington DC/Rockville
Hotel and Executive Meeting Center,
1750 Rockville Pike, Rockville, MD
20852.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061. Rockville,
MD 20852. Submit electronic comments
to https://www.regulations.gov. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
Transcripts of the meeting will be
available for review at the Division of
Dockets Management and on the
Internet at https://www.regulations.gov
approximately 30 days after the
meeting.
FOR FURTHER INFORMATION CONTACT:
Mary Gross, Food and Drug
Administration, Center for Drug
Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 51, rm. 6178,
Silver Spring, MD 20993, 301–796–
3519, FAX: 301–847–8753,
Mary.Gross@fda.hhs.gov; or
Patrick Frey, Food and Drug
Administration, Center for Drug
Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 51, rm. 6350,
Silver Spring, MD 20993, 301–796–
3844, FAX: 301–847–8443,
Patrick.Frey@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
FDA is announcing its intention to
hold a public meeting on PDUFA. The
authority for PDUFA expires in
September 2012. Without new
legislation, FDA will no longer be able
to collect user fees to fund the human
drug review process. Section 736B(d)(2)
(21 U.S.C. 379h-2(d)(2)) of the FD&C Act
requires that before FDA begins
negotiations with the regulated industry
on PDUFA reauthorization, we do the
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following: (1) Publish a notice in the
Federal Register requesting public input
on the reauthorization, (2) hold a public
meeting at which the public may
present its views on the reauthorization,
(3) provide a period of 30 days after the
public meeting to obtain written
comments from the public suggesting
changes, and (4) publish the comments
on the FDA Web site. This notice, the
public meeting, the 30 day comment
period after the meeting, and the posting
of the comments on the FDA Web site
will satisfy these requirements. The
purpose of the meeting is to hear
stakeholder views on PDUFA as we
consider the features to propose in the
next PDUFA program. FDA is interested
in responses to the following two
general questions and welcomes any
other pertinent information stakeholders
would like to share:
1. What is your assessment of the
overall performance of the PDUFA IV
program thus far?
2. What aspects of PDUFA should be
retained, changed, or discontinued to
further strengthen and improve the
program?
The following information is provided
to help potential meeting participants
better understand the history and
evolution of the PDUFA program and its
current status.
II. What is PDUFA? What Does It Do?
PDUFA is a law that authorizes FDA
to collect fees from drug companies that
submit marketing applications for
certain human drug and biological
products. The original PDUFA (PDUFA
I) was enacted in 1992 (as the
Prescription Drug User Fee Act, Public
Law 102–571) and had a 5-year life. In
1997, as PDUFA I expired, Congress
passed the FDA Modernization Act
(FDAMA, Public Law 105–115) which
included an extension of PDUFA
(PDUFA II) for an additional 5 years. In
2002, Congress extended PDUFA again
through fiscal year 2007 (PDUFA III)
through the Public Health Security and
Bioterrorism Preparedness and
Response Act (Public Law 107–188).
Most recently, Title I of the Food and
Drug Administration Amendments Act
of 2007 (FDAAA, Public Law 110–85)
reauthorized PDUFA through fiscal year
2012 (PDUFA IV).
PDUFA’s intent has been to provide
additional revenues so that FDA could
hire more staff, improve systems, and
establish a better managed human drug
review process to make important
therapies available to patients sooner
without compromising review quality or
approval standards. In conjunction with
PDUFA, FDA agrees to certain
performance goals. These goals apply to
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]]>Agencies
[Federal Register Volume 75, Number 50 (Tuesday, March 16, 2010)]
[Notices]
[Pages 12554-12555]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-5675]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Advisory Council on Nurse Education and Practice; 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 meetings:
Name: National Advisory Council on Nurse Education and Practice
(NACNEP).
Dates and Times: April 22, 2010, 8:30 a.m.-4:30 p.m.
April 23, 2010, 8:30 a.m.-4 p.m.
Place: Doubletree Bethesda Hotel & Executive Meeting Center, 8120
Wisconsin Avenue, Bethesda, MD 20814.
Status: The meeting will be open to the public.
Agenda: Agency and Bureau administrative updates will be provided.
Purpose: The purpose of this meeting is to address issues relating
to the role of nursing in primary care and implications for workforce.
The objectives of the meeting are to: (1) Delineate the variety of
roles nurses play in primary care including health promotion,
screening, public education, illness prevention, primary care and
management of stable chronic conditions; (2) review and evaluate the
data related to education preparation and supply of primary care nurses
and advanced practice registered nurses; (3) describe factors that
facilitate and sustain primary care practice by qualified, competent
advanced practice registered nurses; (4) identify the financial and
regulatory barriers to effective, accessible primary care delivered by
nurses and recommended strategies for resolution; and (5) review and
recommend community-based, nurse-directed models for primary care
delivery that are cost effective and produce quality outcomes. This
meeting is a continuation of the meeting that was held November 2009.
Experts from professional nursing, public and private organizations
will make presentations on primary care delivery models. During this
meeting, the NACNEP council
[[Page 12555]]
members will deliberate on the content presented and formulate
recommendations to the Secretary of Health and Human Services and the
Congress on the role of nursing in primary care. This meeting will form
the basis for NACNEP's mandated Tenth Annual Report.
The NACNEP will join the Council on Graduate Medical Education
(COGME), the Advisory Committee on Training in Primary Care Medicine
and Dentistry (ACTPCMD), and the Advisory Committee on
Interdisciplinary, Community-Based Linkages (ACICBL) on April 21, 2010,
for the third Bureau of Health Professions (BHPr) All Advisory
Committee Meeting. Please refer to the Federal Register notice for the
BHPr All Advisory Committee Meeting for additional details.
For further information regarding NACNEP, to obtain a roster of
members, minutes of the meeting, or other relevant information, contact
Lakisha Smith, Executive Secretary, National Advisory Council on Nurse
Education and Practice, Parklawn Building, Room 8C-26, 5600 Fishers
Lane, Rockville, Maryland 20857, telephone (301) 443-5688. Information
can also be found at the following web site: https://bhpr.hrsa.gov/nursing/nacnep.htm
Dated: March 10, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information Coordination.
[FR Doc. 2010-5675 Filed 3-15-10; 8:45 am]
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