Public Health Service Act, Section 330(e), 30098-30099 [E9-14902]
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Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Notices
development and sharing of highly
technical summary results derived from
automated healthcare data in disparate
systems; and what privacy and security
safeguards will be needed and how will
they be maintained.
B. Research Objectives
These initial discussions have focused
on many of the policy and procedural
needs of developing the Sentinel
System. However, to proceed, additional
meetings and working groups need to be
formed to explore in greater depth the
science of safety needed to support this
initiative, as well as methods for
communicating about the information
learned from the system. Topics to be
addressed include specific topics,
issues, and questions related to the
development of active medical product
surveillance methodologies and tools.
Subsequently, the information from
these meetings and working groups
must be described, managed, and made
available to the public using a
transparent and open approach.
C. Eligibility Information
The following organizations/
institutions are eligible to apply: Nonprofit organizations.
Foreign institutions are not eligible to
apply for conference grant support. An
international conference can be
supported through the U.S.
representative organization of an
established international scientific or
professional society.
II. Award Information/Funds Available
A. Award Amount
FDA anticipates providing up to
$600,000 (direct cost only) during fiscal
year (FY) 2009 to support efforts
outlined in this FOA. One award will be
made.
This Cooperative Agreement ensures
substantial FDA involvement in this
program and will include, but not be
limited to, co-development of the
meeting(s) priorities and agendas and
providing feedback on reports and
publications related to meeting
proceedings on identified topics.
B. Length of Support
Subject to the availability of Federal
funds and successful performance, and
if the FOA stated objectives are met, an
additional 4 years of support up to
$600,000 (direct and indirect costs
combined) per year may be available.
III. Electronic Application,
Registration, and Submission
Only electronic applications will be
accepted. To submit an electronic
application in response to this FOA,
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applicants should first review the full
announcement located at https://
www.fda.gov/Safety/FDAsSentinel
Initiative/ucm149345.htm.
For all electronically submitted
applications, the following steps are
required.
• Step 1: Obtain a Dun and Bradstreet
(DUNS) Number
• Step 2: Register With Central
Contractor Registration
• Step 3: Obtain Username &
Password
• Step 4: Authorized Organization
Representative (AOR) Authorization
• Step 5: Track AOR Status
• Step 6: Register With Electronic
Research Administration (eRA)
Commons
Steps 1 through 5, in detail, can be
found at https://www07.grants.gov/
applicants/organization_registration.jsp.
Step 6, in detail, can be found at https://
commons.era.nih.gov/commons/
registration/registrationInstructions.jsp.
After you have followed these steps,
submit electronic applications to https://
www.grants.gov.
Dated: June 19, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–14904 Filed 6–23–09; 8:45 am]
BILLING CODE 4160–01–S
the scientific and technical merit of grant and
cooperative agreement applications received
from academic institutions and other public
and private profit and nonprofit
organizations, including State and local
government agencies, to conduct specific
injury research that focuses on prevention
and control.
Matters To Be Discussed: The meeting will
include the review, discussion, and
evaluation of individual research cooperative
agreement applications submitted in
response to Fiscal Year 2009 Requests for
Applications related to the following
individual research announcement: RFA–
CD–09–001 ‘‘Translating Research to Protect
Health through Health Promotion,
Prevention, and Preparedness (R18)’’ for the
National Center for Injury Prevention and
Control (NCIPC) applications.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information: Jane
Suen, Dr.P.H., M.S., NCIPC, CDC, 4770
Buford Highway, NE., Mailstop F–62,
Atlanta, Georgia 30341. Telephone: (770)
488–4281.
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.
Dated: June 12, 2009.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E9–14740 Filed 6–23–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
Centers for Disease Control and
Prevention
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Center for Injury Prevention
and Control Initial Review Group
(NCIPC IRG)
Health Resources and Services
Administration
Public Health Service Act, Section
330(e)
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 of the
aforementioned committee:
AGENCY: Health Resources and Services
Administration (HRSA), HHS.
ACTION: Notification of Exception to
Competition—Replacement Grant.
Times and Date: 9 a.m.–9:30 a.m., July 14,
2009(Open) 9:30 a.m.–5 p.m., July 14,
2009(Closed) 9 a.m.–5 p.m., July 15,
2009(Closed)
Place: Doubletree Hotel Atlanta-Buckhead,
3342 Peachtree Road, Atlanta, GA 30326,
Telephone: (404) 231–1234.
Status: Portions of the meetings will be
closed to the public in accordance with
provisions set forth in Section 552b(c)(4) and
(6), Title 5, U.S.C., and the Determination of
the Director, Management Analysis and
Services Office, CDC, pursuant to Section
10(d) of Public Law 92–463.
Purpose: This group is charged with
providing advice and guidance to the
Secretary, Department of Health and Human
Services, and the Director, CDC, concerning
SUMMARY: The Health Resources and
Services Administration (HRSA) is
issuing a non-competitive award to the
Community Health Clinics of Northeast
Texas (CHCNET) to avoid disruption
and continue providing primary health
care services to the population of Smith
County, Texas, as an independent
organization from the Northeast Texas
Public Health District (NETPHD).
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award:
Community Health Clinics of Northeast
Texas.
Amount of the Award: $326,308.00
(initial seven-month supplement,
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Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Notices
February 1, 2009, through August 31,
2009) and $601,308.00 (anticipated
second 12-month supplement
September 1, 2009, through August 31,
2010) to ensure ongoing clinical services
to the target population.
Project Period: The current approved
project period for NETPHD which will
be supplemented began on September 1,
2007, and ends August 31, 2010; and its
current budget period ends August 31,
2009.
Authority: This activity is under the
authority of the Public Health Service
Act, Section 330(e).
Catalogue of Federal Domestic
Assistance Number: 93.224.
Justification for the Exception to
Competition: Critical funding for
Primary Health Care services to the
population of Smith County, Texas, will
be continued through a non-competitive
award to Community Health Clinics of
Northeast Texas as a new recipient. This
non-competitive award is made because
the previous grant recipient (NETPHD)
serving this population notified HRSA
that they would relinquish the grant and
its responsibility to CHCNET. CHCNET
has been responsible for the clinical
operations of the program and will
continue to operate the previously
approved scope of project without
significant changes in the organizational
structure. This non-competitive
replacement award will permit the new
recipient to maintain the service
delivery program and will ensure
continuity of services. The initial
supplemental funding will provide
support for 7 months. Based on
satisfactory performance, continued
need, and availability of funds, a second
and final supplemental award for these
services will be awarded for 12 months.
Further funding beyond August 31,
2010, for this service area will be
competitively awarded during the next
PHS Section 330 Health Center Program
competing application process. The next
available PHS Section 330 Health Center
Program open competing cycle will
occur in fiscal year 2009.
FOR FURTHER INFORMATION CONTACT:
Monica Toomer, Chief, Southwest
Branch, Central Mid-Atlantic Division,
Bureau of Primary Health Care, Health
Services and Resources Administration,
5600 Fishers Lane, Rockville, MD
20857; phone 301–594–4434;
Monica.Toomer@hrsa.hhs.gov.
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Dated: June 18, 2009.
Mary K. Wakefield,
Administrator.
[FR Doc. E9–14902 Filed 6–23–09; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
The Essentials of Medical Device
Regulations: A Primer for
Manufacturers and Importers; Public
Seminar
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public seminar.
SUMMARY: The Food and Drug
Administration’s (FDA’s) Center for
Devices and Radiological Health and
Office of Regulatory Affairs, in
cooperation with AdvaMed’s Medical
Technology Learning Institute, is
announcing a series of three public
seminars on FDA medical device
regulations.
These 2-day public seminars, which
are designed to address the training
needs of startup and small device
manufacturers and their suppliers, will
include both industry and FDA
perspectives and a question and answer
period.
DATES: For the dates of the public
seminars, see table 1 in the
SUPPLEMENTARY INFORMATION section of
this document.
ADDRESSES: For the locations of the
public seminars, see table 1 in the
SUPPLEMENTARY INFORMATION section of
this document.
FOR FURTHER INFORMATION CONTACT:
For FDA:
William Sutton, Division of Small
Manufacturers, International and
Consumer Assistance, Center for
Devices and Radiological Health,
10903 New Hampshire Ave., W066–
4626, Silver Spring, MD 20993–
0002, 301–796–5849, FAX: 301–
847–8149, e-mail:
William.Sutton@fda.hhs.gov.
For AdvaMed:
For hotel and general information:
Veronica Allen, 202–434–7231,
vallen@advamed.org.
For registration information: Katia
Kunze, 202–434–7237, FAX: 202–
783–8750, kkunze@advamed.org
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SUPPLEMENTARY INFORMATION:
I. Background
The ‘‘Essentials of Medical Device
Regulations: A Primer for Manufacturers
and Importers’’ seminar helps fulfill the
Department of Health and Human
Services’ and FDA’s important mission
to protect the public health by educating
new entrepreneurs on the essentials of
FDA device regulations. FDA has made
education of the medical device
community a high priority to assure the
quality of products reaching the
marketplace and to increase the rate of
voluntary industry compliance with
regulations.
The seminar helps to implement the
objectives of section 903 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
393) and the FDA Plan for Statutory
Compliance, which includes working
more closely with stakeholders and
ensuring access to needed scientific and
technical expertise.
The seminar also furthers the goals of
the Small Business Regulatory
Enforcement Fairness Act (Public Law
104–121) by providing outreach
activities by Government agencies
directed at small businesses.
The following topics, as well as
others, will be discussed at the seminar:
• Doing business in a regulated
industry;
• Organizational structure of FDA;
• Overview of the quality system
regulation;
• Design controls;
• Documents, records, and change
control;
• Purchasing controls and acceptance
activities;
• Production and process control;
• Corrective and preventive actions;
• Complaints, medical device reports,
corrections, and recalls;
• Compliance issues;
• Management responsibility;
• Interacting with FDA—Where do
you go for assistance?
• General question and answer
session;
• Manufacturers and suppliers—The
chain regulatory responsibility;
• Reimbursement of medical
technology;
• The AdvaMed code of ethics; and
• Fraud and abuse.
II. Public Seminar Locations and Dates
The locations and dates for the public
seminars are listed in table 1 of this
document.
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]]>Agencies
[Federal Register Volume 74, Number 120 (Wednesday, June 24, 2009)]
[Notices]
[Pages 30098-30099]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-14902]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Public Health Service Act, Section 330(e)
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Notification of Exception to Competition--Replacement Grant.
-----------------------------------------------------------------------
SUMMARY: The Health Resources and Services Administration (HRSA) is
issuing a non-competitive award to the Community Health Clinics of
Northeast Texas (CHCNET) to avoid disruption and continue providing
primary health care services to the population of Smith County, Texas,
as an independent organization from the Northeast Texas Public Health
District (NETPHD).
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award: Community Health Clinics of
Northeast Texas.
Amount of the Award: $326,308.00 (initial seven-month supplement,
[[Page 30099]]
February 1, 2009, through August 31, 2009) and $601,308.00 (anticipated
second 12-month supplement September 1, 2009, through August 31, 2010)
to ensure ongoing clinical services to the target population.
Project Period: The current approved project period for NETPHD
which will be supplemented began on September 1, 2007, and ends August
31, 2010; and its current budget period ends August 31, 2009.
Authority: This activity is under the authority of the Public
Health Service Act, Section 330(e).
Catalogue of Federal Domestic Assistance Number: 93.224.
Justification for the Exception to Competition: Critical funding
for Primary Health Care services to the population of Smith County,
Texas, will be continued through a non-competitive award to Community
Health Clinics of Northeast Texas as a new recipient. This non-
competitive award is made because the previous grant recipient (NETPHD)
serving this population notified HRSA that they would relinquish the
grant and its responsibility to CHCNET. CHCNET has been responsible for
the clinical operations of the program and will continue to operate the
previously approved scope of project without significant changes in the
organizational structure. This non-competitive replacement award will
permit the new recipient to maintain the service delivery program and
will ensure continuity of services. The initial supplemental funding
will provide support for 7 months. Based on satisfactory performance,
continued need, and availability of funds, a second and final
supplemental award for these services will be awarded for 12 months.
Further funding beyond August 31, 2010, for this service area will be
competitively awarded during the next PHS Section 330 Health Center
Program competing application process. The next available PHS Section
330 Health Center Program open competing cycle will occur in fiscal
year 2009.
FOR FURTHER INFORMATION CONTACT: Monica Toomer, Chief, Southwest
Branch, Central Mid-Atlantic Division, Bureau of Primary Health Care,
Health Services and Resources Administration, 5600 Fishers Lane,
Rockville, MD 20857; phone 301-594-4434; Monica.Toomer@hrsa.hhs.gov.
Dated: June 18, 2009.
Mary K. Wakefield,
Administrator.
[FR Doc. E9-14902 Filed 6-23-09; 8:45 am]
BILLING CODE 4165-15-P
