Medicaid Program: Notice of Single Source Grant Award to the State of Louisiana for the Grant Entitled “Deficit Reduction Act-Hurricane Katrina Healthcare Related Primary Care Access Stabilization Grant”, 51230-51231 [E7-17560]
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51230
Federal Register / Vol. 72, No. 172 / Thursday, September 6, 2007 / Notices
Dated: August 30, 2007.
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. E7–17617 Filed 9–5–07; 8:45 am]
Dated: August 30, 2007.
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. E7–17618 Filed 9–5–07; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute for Occupational
Safety and Health; Designation of a
Class of Employees for Addition to the
Special Exposure Cohort
National Institute for Occupational
Safety and Health
Medicaid Program: Notice of Single
Source Grant Award to the State of
Louisiana for the Grant Entitled
‘‘Deficit Reduction Act—Hurricane
Katrina Healthcare Related Primary
Care Access Stabilization Grant’’
National Institute for
Occupational Safety and Health
(NIOSH), Department of Health and
Human Services (HHS).
AGENCY:
ACTION:
National Institute for
Occupational Safety and Health
(NIOSH), Department of Health and
Human Services (HHS).
AGENCY:
Notice.
The Department of Health and
Human Services (HHS) gives notice of a
decision to designate a class of
employees at the Rocky Flats Plant,
Golden, Colorado, as an addition to the
Special Exposure Cohort (SEC) under
the Energy Employees Occupational
Illness Compensation Program Act of
2000. On August 6, 2007, the Secretary
of HHS designated the following class of
employees as an addition to the SEC:
SUMMARY:
Employees of the Department of Energy
(DOE), its predecessor agencies, or DOE
contractors or subcontractors who were
monitored or should have been monitored for
neutron exposures while working at the
Rocky Flats Plant in Golden, Colorado, for a
number of work days aggregating at least 250
work days from January 1, 1959, through
December 31, 1966, or in combination with
work days within the parameters established
for one or more other classes of employees
in the Special Exposure Cohort.
This designation will become effective
on September 5, 2007, unless Congress
provides otherwise prior to the effective
date. After this effective date, HHS will
publish a notice in the Federal Register
reporting the addition of this class to the
SEC or the result of any provision by
Congress regarding the decision by HHS
to add the class to the SEC.
mstockstill on PROD1PC66 with NOTICES
FOR FURTHER INFORMATION CONTACT:
Larry Elliott, Director, Office of
Compensation Analysis and Support,
National Institute for Occupational
Safety and Health (NIOSH), 4676
Columbia Parkway, MS C–46,
Cincinnati, OH 45226, Telephone 513–
533–6800 (this is not a toll-free
number). Information requests can also
be submitted by e-mail to
OCAS@CDC.GOV.
VerDate Aug<31>2005
18:25 Sep 05, 2007
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Determination Concerning a Petition to
Add a Class of Employees to the
Special Exposure Cohort
ACTION:
Notice.
SUMMARY: The Department of Health and
Human Services (HHS) gives notice of a
determination concerning a petition to
add a class of employees at the Rocky
Flats Plant, Golden, Colorado, to the
Special Exposure Cohort (SEC) under
the Energy Employees Occupational
Illness Compensation Program Act of
2000 (EEOICPA), 42 U.S.C. 7384q. On
August 6, 2007, the Secretary of HHS
determined that the following
employees do not meet the statutory
criteria for addition to the SEC as
authorized under EEOICPA:
Department of Energy employees or its
contractor or subcontractor employees at the
Rocky Flats plant in Golden, Colorado, who
were exposed to radiation dose from 1967
through 2005 and who were exposed to any
radiation dose other than neutron dose from
1952 through 1966.
FOR FURTHER INFORMATION CONTACT:
Larry Elliott, Director, Office of
Compensation Analysis and Support,
National Institute for Occupational
Safety and Health (NIOSH), 4676
Columbia Parkway, MS C–46,
Cincinnati, OH 45226, Telephone 513–
533–6800 (this is not a toll-free
number). Information requests can also
be submitted by e-mail to
OCAS@CDC.GOV.
Dated: August 30, 2007.
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. E7–17620 Filed 9–5–07; 8:45 am]
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Centers for Medicare & Medicaid
Services
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
Funding Amount: $100,000,000.
Period of Performance: July 23, 2007
through September 30, 2010.
CFDA: 93.776.
Authority: Section 6201(a)(4) of the Deficit
Reduction Act of 2005 (DRA).
Purpose: This grant program has been
made available to the State of Louisiana
to restore and expand access to primary
care, including primary mental health
care, in the Greater New Orleans area.
This area is facing inadequate primary
care access as a result of Hurricane
Katrina and its subsequent floods
causing a unique negative impact on the
low income and uninsured populations
of Greater New Orleans. Funding under
this grant program must be used by the
State of Louisiana to assist it to make
payments for purposes of addressing
primary health care access issues in
Greater New Orleans’ ‘‘impacted
communities’’, defined for purposes of
this grant, to be those four parishes
located in the State of Louisiana’s
Region 1, as defined by the Louisiana
Department of Health and Hospitals,
namely, Orleans, Jefferson, St. Bernard,
and Plaquemines. This grant includes
$4,000,000 for the City of New Orleans
Health Department to help restore its
ability to meet its primary care mission
in new and emerging neighborhoods
being repopulated.
The grant funds must be used only for
funding eligible primary care clinics
that: Provide at least one or more of the
core primary care services with its own
practitioners in an outpatient setting;
formally commit to provide care to all
individuals, regardless of ability to pay;
are either a public or not-for-profit
(NFP) entity that is sustainable; and
demonstrate commitment to practice in
the Greater New Orleans area for the
long term. Because of the urgent need to
get funds out as timely as possible
under less than ideal local
circumstances, the State of Louisiana
has selected a locally based partner (that
was able to meet certain criteria) to
oversee and monitor local conditions,
E:\FR\FM\06SEN1.SGM
06SEN1
Federal Register / Vol. 72, No. 172 / Thursday, September 6, 2007 / Notices
and run the grant day-to-day.
Administrative expenses will be capped
at .5 percent for the State and 5 percent
for the local partner.
The State of Louisiana, in
consultation with its local partner, has
flexibility subject to approval by the
Centers for Medicare & Medicaid
Services (CMS) in determining the
funding allocation methodology to
grantee clinics/subawardees, as long as
it includes a standardization of ‘‘units of
care’’ across all grantee clinics, and
includes a base award and
supplementary payments that meet the
intent of the grant.
This award was made based on the
authority granted by section 6201 of the
Deficit Reduction Act (DRA). In
particular, section 6201(a)(4) of the DRA
provides authority to the Secretary,
Department of Health and Human
Services (DHHS), to make payments to
States to restore access to health care in
communities impacted by Hurricane
Katrina.
Under the authority of section
6201(a)(4) of the DRA of 2005, the
Secretary has invoked his authority to
restore health care in impacted
communities affected by Hurricane
Katrina by offering this unique funding
opportunity to stabilize primary health
care access to the Greater New Orleans
area, which is facing inadequate
primary care access as a result of
Hurricane Katrina and its subsequent
floods.
Louisiana is the only State with the
knowledge and ability to administer a
grant designed to affect impacted
Louisiana communities. For this reason,
the Secretary has directed CMS to offer
a single-source award to the State of
Louisiana to help strengthen and
increase primary care access to the
Greater New Orleans area and by
helping to increase the supply of health
care providers negatively impacted as a
result of this hurricane.
FOR FURTHER INFORMATION CONTACT:
Wendy J. Taparanskas, Ph.D., Health
Insurance Specialist, Finance, Systems,
and Budget Group, Center for Medicaid
and State Operations, Centers for
Medicare & Medicaid Services, Mail
Stop S3–13–15, 7500 Security
Boulevard, Baltimore, MD 21244, (410)
786–5245.
mstockstill on PROD1PC66 with NOTICES
Authority: Section 6201(a)(4) of the Deficit
Reduction Act of 2005 (DRA).
Dated: August 30, 2007.
Herb B. Kuhn,
Acting Deputy Administrator, Centers for
Medicare & Medicaid Services.
[FR Doc. E7–17560 Filed 9–5–07; 8:45 am]
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18:25 Sep 05, 2007
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0218]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Adverse Event
Pilot Program for Medical Products
(Formally Medical Device Adverse
Event Reporting Program)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by October 9,
2007.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0471. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1427.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance:
Adverse Event Pilot Program for
Medical Products—21 U.S.C. 360(i)
(OMB Control Number 0910–0471)—
Extension
Under section 519 of the Food, Drug
and Cosmetic Act (the act) (21 U.S.C.
360(i)), FDA is authorized to require:
Manufacturers to report medical device
related deaths, serious injuries, and
malfunctions; and user facilities to
report device-related deaths directly to
manufacturers and FDA, and to report
serious injuries to the manufacturer.
Section 213 of the FDA Modernization
Act of 1997 (FDAMA), amended section
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51231
519(b) of the act (21 U.S.C. 360 i(b))
relating to mandatory reporting by user
facilities of deaths and serious injuries
and serious illnesses associated with the
use of medical devices. This
amendment legislated the replacement
of universal user facility reporting by a
system that is limited to a ‘‘. . . subset
of user facilities that constitutes a
representative profile of user reports’’
for device related deaths and serious
injuries. This amendment is reflected in
section 519(b)(5)(A) of the act. The
current universal reporting system
remains in place during the pilot stages
of the new program, and until FDA
implements the new national system by
regulation. This legislation provides
FDA with the opportunity to design and
implement a national surveillance
network, composed of well-trained
clinical facilities, to provide high
quality data on medical devices in
clinical use. This system is called the
Medical Product Safety Network
(MedSun).
FDA is continuing to conduct a pilot
of the MedSun system before the agency
issues a regulation to change from
universal mandatory reporting for
medical device user facilities to
reporting by a representative sample of
facilities. This data collection has been
ongoing since February 20, 2002, and
this notice is for continuation of this
data collection.
FDA is seeking OMB clearance to
continue to use electronic data
collection to obtain the information on
the 3500A Form related to medical
devices and tissue products from the
user facilities participating in MedSun,
to obtain a demographic profile of the
facilities, and to pilot a few additional
questions which will permit FDA to
better understand the cause of the
reported adverse event. During the pilot
program, participants will be asked to
complete an annual outcome measures
form to aid FDA in evaluating the
effectiveness of the program.
Participation in this pilot is voluntary
and currently includes 400 facilities and
over 100 beds. The use of an interactive
electronic data collection system is
easier and more efficient for the
participating user facilities to use than
the alternative paper system. The paper
form takes approximately 1 hour to
complete and the electronic version
takes approximately 45 minutes or less
to complete. Much of the data which
must be filled in by hand on the paper
system is automatically filled in by the
electronic version.
In addition to collecting data on the
electronic adverse event report form,
MedSun also collects data electronically
in the Device-Safety Exchange (DS-X).
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]]>Agencies
[Federal Register Volume 72, Number 172 (Thursday, September 6, 2007)]
[Notices]
[Pages 51230-51231]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-17560]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
Medicaid Program: Notice of Single Source Grant Award to the
State of Louisiana for the Grant Entitled ``Deficit Reduction Act--
Hurricane Katrina Healthcare Related Primary Care Access Stabilization
Grant''
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
Funding Amount: $100,000,000.
Period of Performance: July 23, 2007 through September 30, 2010.
CFDA: 93.776.
Authority: Section 6201(a)(4) of the Deficit Reduction Act of
2005 (DRA).
Purpose: This grant program has been made available to the State of
Louisiana to restore and expand access to primary care, including
primary mental health care, in the Greater New Orleans area. This area
is facing inadequate primary care access as a result of Hurricane
Katrina and its subsequent floods causing a unique negative impact on
the low income and uninsured populations of Greater New Orleans.
Funding under this grant program must be used by the State of Louisiana
to assist it to make payments for purposes of addressing primary health
care access issues in Greater New Orleans' ``impacted communities'',
defined for purposes of this grant, to be those four parishes located
in the State of Louisiana's Region 1, as defined by the Louisiana
Department of Health and Hospitals, namely, Orleans, Jefferson, St.
Bernard, and Plaquemines. This grant includes $4,000,000 for the City
of New Orleans Health Department to help restore its ability to meet
its primary care mission in new and emerging neighborhoods being
repopulated.
The grant funds must be used only for funding eligible primary care
clinics that: Provide at least one or more of the core primary care
services with its own practitioners in an outpatient setting; formally
commit to provide care to all individuals, regardless of ability to
pay; are either a public or not-for-profit (NFP) entity that is
sustainable; and demonstrate commitment to practice in the Greater New
Orleans area for the long term. Because of the urgent need to get funds
out as timely as possible under less than ideal local circumstances,
the State of Louisiana has selected a locally based partner (that was
able to meet certain criteria) to oversee and monitor local conditions,
[[Page 51231]]
and run the grant day-to-day. Administrative expenses will be capped at
.5 percent for the State and 5 percent for the local partner.
The State of Louisiana, in consultation with its local partner, has
flexibility subject to approval by the Centers for Medicare & Medicaid
Services (CMS) in determining the funding allocation methodology to
grantee clinics/subawardees, as long as it includes a standardization
of ``units of care'' across all grantee clinics, and includes a base
award and supplementary payments that meet the intent of the grant.
This award was made based on the authority granted by section 6201
of the Deficit Reduction Act (DRA). In particular, section 6201(a)(4)
of the DRA provides authority to the Secretary, Department of Health
and Human Services (DHHS), to make payments to States to restore access
to health care in communities impacted by Hurricane Katrina.
Under the authority of section 6201(a)(4) of the DRA of 2005, the
Secretary has invoked his authority to restore health care in impacted
communities affected by Hurricane Katrina by offering this unique
funding opportunity to stabilize primary health care access to the
Greater New Orleans area, which is facing inadequate primary care
access as a result of Hurricane Katrina and its subsequent floods.
Louisiana is the only State with the knowledge and ability to
administer a grant designed to affect impacted Louisiana communities.
For this reason, the Secretary has directed CMS to offer a single-
source award to the State of Louisiana to help strengthen and increase
primary care access to the Greater New Orleans area and by helping to
increase the supply of health care providers negatively impacted as a
result of this hurricane.
FOR FURTHER INFORMATION CONTACT: Wendy J. Taparanskas, Ph.D., Health
Insurance Specialist, Finance, Systems, and Budget Group, Center for
Medicaid and State Operations, Centers for Medicare & Medicaid
Services, Mail Stop S3-13-15, 7500 Security Boulevard, Baltimore, MD
21244, (410) 786-5245.
Authority: Section 6201(a)(4) of the Deficit Reduction Act of
2005 (DRA).
Dated: August 30, 2007.
Herb B. Kuhn,
Acting Deputy Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E7-17560 Filed 9-5-07; 8:45 am]
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