Notice of Intent To Award Affordable Care Act (ACA) Funding, RFA-TP-08-001, 59703-59704 [2011-24747]
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Federal Register / Vol. 76, No. 187 / Tuesday, September 27, 2011 / Notices
On March
23, 2010, the President signed into law
the Affordable Care Act (ACA), Public
Law 111–148. ACA is designed to
improve and expand the scope of health
care coverage for Americans. Cost
savings through disease prevention is an
important element of this legislation
and ACA has established a Prevention
and Public Health Fund (PPHF) for this
purpose. Specifically, the legislation
states in Section 4002 that the PPHF is
to ‘‘provide for expanded and sustained
national investment in prevention and
public health programs to improve
health and help restrain the rate of
growth in private and public sector
health care costs.’’ ACA and the
Prevention and Public Health Fund
make improving public health a priority
with investments to improve public
health.
The PPHF states that the Secretary
shall transfer amounts in the Fund to
accounts within the Department of
Health and Human Services to increase
funding, over the fiscal year 2008 level,
for programs authorized by the Public
Health Service Act, for prevention,
wellness and public health activities
including prevention research and
health screenings, such as the
Community Transformation Grant
Program, the Education and Outreach
Campaign for Preventative Benefits, and
Immunization Programs.
Therefore, increasing funding
available to applicants under this FOA
using the PPHF will allow them to
sustain their existing to provide for a
national investment in prevention and
public health programs. Further, The
Secretary allocated funds to CDC,
pursuant to the PPHF, for the types of
activities this FOA is designed to carry
out.
SUPPLEMENTARY INFORMATION:
Dated: August 16, 2011.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2011–24750 Filed 9–26–11; 8:45 am]
BILLING CODE 4163–18–P
Authority: Sections 311 and 317 (k)(2) of
the Public Health Service Act, [42 U. S. C.
Section 243 and 247b(k)(2)] as amended,
Patient Protection and Affordable Care Act
(ACA), Section 4002 (42 U.S.C. 300u–11).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on DSK4VPTVN1PROD with NOTICES
Centers for Disease Control and
Prevention
Notice of Intent To Award Affordable
Care Act (ACA) Funding, RFA–TP–08–
001
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
VerDate Mar<15>2010
16:35 Sep 26, 2011
Jkt 223001
Overview Information
Notice of Intent to award Affordable
Care Act (ACA) funding to Preparedness
and Emergency Response Research
Centers (PERRCs). This award is
proposed for the grantees’ Fiscal Year
(FY) 2011 non-competing continuation
application under Funding Opportunity
Announcement RFA–TP–08–001,
‘‘Preparedness and Emergency Response
Research Centers: A Public Health
Systems Approach.’’
SUMMARY: This notice provides public
announcement of CDC’s intent to award
Affordable Care Act (ACA)
appropriations to the following 4
Preparedness and Emergency Response
Research Center (PERRCs) grantees: the
University of North Carolina in Chapel
Hill, NC; the University of Minnesota in
Minneapolis, MN; the University of
California in Berkeley; and the
University of California in Los Angeles,
CA.
The purpose of the PERRC program is
to conduct public health systems
research to strengthen preparedness and
response capabilities at the national,
state, local, and tribal levels for
preventing morbidity and mortality
from threats to the public’s health such
as infectious disease outbreaks, and
man-made and natural disasters.
These activities are proposed by the
above mentioned grantees in their FY
2011 application for continuation
submitted under Funding Opportunity
Announcement RFA–TP–08–001,
‘‘Preparedness and Emergency Response
Research Centers: A Public Health
Systems Approach,’’ Catalogue of
Federal Domestic Assistance Number
(CFDA): 93.061 Approximately
$5,000,000 in ACA funding will be
awarded to these grantees for sustaining
approved program activities. Funding is
appropriated under the Affordable Care
Act (Pub. L. 111–148), Section 4002 (42
U.S.C. 300u–11) (Prevention and Public
Health Fund).
Accordingly, CDC adds the following
information to the previously published
Funding Opportunity Announcement of
RFA–TP–08–001:
CFDA #: 93.607 (Affordable Care Act—
Preparedness and Emergency Response
Research Centers: A Public Health Systems
Approach)
Award Information
Type of Award: Non-Competing
Continuation Cooperative Agreement.
Approximate Total Current Fiscal
Year ACA Funding: $5,000,000.
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59703
Anticipated Number of Awards: 4.
Fiscal Year Funds: 2011 .
Anticipated Award Date: September
30, 2011.
Application Selection Process
Funding will be awarded to the
applicants based on the following
criteria from the funding opportunity
announcement:
• Accomplishments reflected in the
progress report of the continuation
application that indicate that the
applicant is meeting previously stated
objectives or milestones contained in
the project’s annual work plan and
satisfactory progress is being
demonstrated. The report should
contain progress in core activities,
including a report on advisory
committee meeting(s), activities, etc.,
and progress in individual research
projects.
• Objectives for the new budget
period are realistic, specific, and
measurable. Methods described will
clearly lead to achievement of these
objectives. An evaluation plan that will
allow management to monitor whether
the methods are effective.
• Any impediments to progress are
described, e.g., milestones that are
deficient or deferred are fully explained,
and the corrective action taken to
address the impediment is described
including specific information on
revised dates of completion of the
milestones impacted.
A budget request that is clearly
explained, adequately justified,
reasonable and consistent with the
intended use of program project grant
funds.
Funding Authority
CDC will add the ACA Authority to
that which is reflected in the published
Funding Opportunity Announcement
RFA–TP–08–001. The revised funding
authority language will read:
—This program is authorized under the
Sections 311 and 317 (k)(2) of the
Public Health Service Act, [42 U.S.C.
Section 243 and 247b(k)(2)] as
amended, Patient Protection and
Affordable Care Act (ACA), Section
4002 (42 U.S.C. 300u–11).
DATES: The effective date for this action
is the date of publication of this Notice
and remains in effect until the
expiration of the project period of the
ACA funded applications.
FOR FURTHER INFORMATION CONTACT:
Mildred Williams-Johnson, PhD.,
Director, Extramural Research Program
Office, Office of Public Health
Preparedness and Response, Centers for
Disease Control and Prevention,
E:\FR\FM\27SEN1.SGM
27SEN1
59704
Federal Register / Vol. 76, No. 187 / Tuesday, September 27, 2011 / Notices
telephone 770–488–8806, MWilliamsJohnson@cdc.gov
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
On March
23, 2010, the President signed into law
the Affordable Care Act (ACA), Public
Law 111–148. ACA is designed to
improve and expand the scope of health
care coverage for Americans. Cost
savings through disease prevention is an
important element of this legislation
and ACA has established a Prevention
and Public Health Fund (PPHF) for this
purpose. Specifically, the legislation
states in Section 4002 that the PPHF is
to ‘‘provide for expanded and sustained
national investment in prevention and
public health programs to improve
health and help restrain the rate of
growth in private and public sector
health care costs.’’ ACA and the
Prevention and Public Health Fund
make improving public health a priority
with investments to improve public
health.
The PPHF states that the Secretary
shall transfer amounts in the Fund to
accounts within the Department of
Health and Human Services to increase
funding, over the fiscal year 2008 level,
for programs authorized by the Public
Health Service Act, for prevention,
wellness and public health activities
including prevention research and
health screenings, such as the
Community Transformation Grant
Program, the Education and Outreach
Campaign for Preventative Benefits, and
Immunization Programs.
Therefore, increasing funding
available to applicants under this FOA
using the PPHF will allow them to
sustain their existing to provide for a
national investment in prevention and
public health programs. Further, The
Secretary allocated funds to CDC,
pursuant to the PPHF, for the types of
activities this FOA is designed to carry
out.
Food and Drug Administration
SUPPLEMENTARY INFORMATION:
Dated: September 16, 2011.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2011–24747 Filed 9–26–11; 8:45 am]
mstockstill on DSK4VPTVN1PROD with NOTICES
BILLING CODE 4163–18–P
VerDate Mar<15>2010
16:35 Sep 26, 2011
Jkt 223001
[Docket No. FDA–2011–N–0672]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prominent and
Conspicuous Mark of Manufacturers
on Single-Use Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
reprocessed single-use device labeling.
DATES: Submit either electronic or
written comments on the collection of
information by November 28, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
SUMMARY:
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proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Prominent and Conspicuous Mark of
Manufacturers on Single-Use Devices
(OMB Control Number 0910–0577)—
Extension
Section 502 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
352), among other things, establishes
requirements that the label or labeling of
a medical device must meet so that it is
not misbranded and subject to
regulatory action. Section 301 of the
Medical Device User Fee and
Modernization Act of 2002 (Pub. L. 107–
250) amended section 502 of the FD&C
Act to add section 502(u) to require
devices (both new and reprocessed) to
bear prominently and conspicuously the
name of the manufacturer, a generally
recognized abbreviation of such name,
or a unique and generally recognized
symbol identifying the manufacturer.
Thus, the name for this information
collection activity has been changed to
more accurately describe the
information collection content.
Section 2(c) of the Medical Device
User Fee Stabilization Act of 2005 (Pub.
L. 109–43) amends section 502(u) of the
FD&C Act by limiting the provision to
reprocessed single-use devices (SUDs)
and the manufacturers who reprocess
them. Under the amended provision, if
the original SUD or an attachment to it
prominently and conspicuously bears
the name of the manufacturer, then the
reprocessor of the SUD is required to
identify itself by name, abbreviation, or
symbol, in a prominent and
conspicuous manner on the device or
attachment to the device. If the original
E:\FR\FM\27SEN1.SGM
27SEN1
Agencies
[Federal Register Volume 76, Number 187 (Tuesday, September 27, 2011)]
[Notices]
[Pages 59703-59704]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24747]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Notice of Intent To Award Affordable Care Act (ACA) Funding, RFA-
TP-08-001
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
Overview Information
Notice of Intent to award Affordable Care Act (ACA) funding to
Preparedness and Emergency Response Research Centers (PERRCs). This
award is proposed for the grantees' Fiscal Year (FY) 2011 non-competing
continuation application under Funding Opportunity Announcement RFA-TP-
08-001, ``Preparedness and Emergency Response Research Centers: A
Public Health Systems Approach.''
SUMMARY: This notice provides public announcement of CDC's intent to
award Affordable Care Act (ACA) appropriations to the following 4
Preparedness and Emergency Response Research Center (PERRCs) grantees:
the University of North Carolina in Chapel Hill, NC; the University of
Minnesota in Minneapolis, MN; the University of California in Berkeley;
and the University of California in Los Angeles, CA.
The purpose of the PERRC program is to conduct public health
systems research to strengthen preparedness and response capabilities
at the national, state, local, and tribal levels for preventing
morbidity and mortality from threats to the public's health such as
infectious disease outbreaks, and man-made and natural disasters.
These activities are proposed by the above mentioned grantees in
their FY 2011 application for continuation submitted under Funding
Opportunity Announcement RFA-TP-08-001, ``Preparedness and Emergency
Response Research Centers: A Public Health Systems Approach,''
Catalogue of Federal Domestic Assistance Number (CFDA): 93.061
Approximately $5,000,000 in ACA funding will be awarded to these
grantees for sustaining approved program activities. Funding is
appropriated under the Affordable Care Act (Pub. L. 111-148), Section
4002 (42 U.S.C. 300u-11) (Prevention and Public Health Fund).
Accordingly, CDC adds the following information to the previously
published Funding Opportunity Announcement of RFA-TP-08-001:
Authority: Sections 311 and 317 (k)(2) of the Public Health
Service Act, [42 U. S. C. Section 243 and 247b(k)(2)] as amended,
Patient Protection and Affordable Care Act (ACA), Section 4002 (42
U.S.C. 300u-11).
CFDA : 93.607 (Affordable Care Act--Preparedness and
Emergency Response Research Centers: A Public Health Systems
Approach)
Award Information
Type of Award: Non-Competing Continuation Cooperative Agreement.
Approximate Total Current Fiscal Year ACA Funding: $5,000,000.
Anticipated Number of Awards: 4.
Fiscal Year Funds: 2011 .
Anticipated Award Date: September 30, 2011.
Application Selection Process
Funding will be awarded to the applicants based on the following
criteria from the funding opportunity announcement:
Accomplishments reflected in the progress report of the
continuation application that indicate that the applicant is meeting
previously stated objectives or milestones contained in the project's
annual work plan and satisfactory progress is being demonstrated. The
report should contain progress in core activities, including a report
on advisory committee meeting(s), activities, etc., and progress in
individual research projects.
Objectives for the new budget period are realistic,
specific, and measurable. Methods described will clearly lead to
achievement of these objectives. An evaluation plan that will allow
management to monitor whether the methods are effective.
Any impediments to progress are described, e.g.,
milestones that are deficient or deferred are fully explained, and the
corrective action taken to address the impediment is described
including specific information on revised dates of completion of the
milestones impacted.
A budget request that is clearly explained, adequately justified,
reasonable and consistent with the intended use of program project
grant funds.
Funding Authority
CDC will add the ACA Authority to that which is reflected in the
published Funding Opportunity Announcement RFA-TP-08-001. The revised
funding authority language will read:
--This program is authorized under the Sections 311 and 317 (k)(2) of
the Public Health Service Act, [42 U.S.C. Section 243 and 247b(k)(2)]
as amended, Patient Protection and Affordable Care Act (ACA), Section
4002 (42 U.S.C. 300u-11).
DATES: The effective date for this action is the date of publication of
this Notice and remains in effect until the expiration of the project
period of the ACA funded applications.
FOR FURTHER INFORMATION CONTACT: Mildred Williams-Johnson, PhD.,
Director, Extramural Research Program Office, Office of Public Health
Preparedness and Response, Centers for Disease Control and Prevention,
[[Page 59704]]
telephone 770-488-8806, MWilliams-Johnson@cdc.gov
SUPPLEMENTARY INFORMATION: On March 23, 2010, the President signed into
law the Affordable Care Act (ACA), Public Law 111-148. ACA is designed
to improve and expand the scope of health care coverage for Americans.
Cost savings through disease prevention is an important element of this
legislation and ACA has established a Prevention and Public Health Fund
(PPHF) for this purpose. Specifically, the legislation states in
Section 4002 that the PPHF is to ``provide for expanded and sustained
national investment in prevention and public health programs to improve
health and help restrain the rate of growth in private and public
sector health care costs.'' ACA and the Prevention and Public Health
Fund make improving public health a priority with investments to
improve public health.
The PPHF states that the Secretary shall transfer amounts in the
Fund to accounts within the Department of Health and Human Services to
increase funding, over the fiscal year 2008 level, for programs
authorized by the Public Health Service Act, for prevention, wellness
and public health activities including prevention research and health
screenings, such as the Community Transformation Grant Program, the
Education and Outreach Campaign for Preventative Benefits, and
Immunization Programs.
Therefore, increasing funding available to applicants under this
FOA using the PPHF will allow them to sustain their existing to provide
for a national investment in prevention and public health programs.
Further, The Secretary allocated funds to CDC, pursuant to the PPHF,
for the types of activities this FOA is designed to carry out.
Dated: September 16, 2011.
Tanja Popovic,
Deputy Associate Director for Science, Centers for Disease Control and
Prevention.
[FR Doc. 2011-24747 Filed 9-26-11; 8:45 am]
BILLING CODE 4163-18-P