[Federal Register: August 23, 2005 (Volume 70, Number 162)]
[Notices]
[Page 49282-49288]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23au05-82]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Epi-Centers for Prevention of Healthcare-Associated Infections
Announcement Type: New.
Funding Opportunity Number: CI06-001.
Catalog of Federal Domestic Assistance Number: 93.283.
Letter of Intent Deadline: September 22, 2005.
Application Deadline: October 24, 2005.
I. Funding Opportunity Description
Authority: 42 U.S.C. 247b(k)(2).
[[Page 49283]]
Background: Healthcare-associated infections (HAIs) and other
adverse events continue to cause significant morbidity and mortality
among patients treated in U.S. healthcare institutions and add billions
of dollars to healthcare costs in the United States. However, estimates
of the burden of these adverse events at the local, state, and national
levels are inexact because surveillance methods are neither
standardized nor uniformly applied in U.S. health care facilities. In
addition, at the facility level, surveillance data vary in quality,
completeness, timeliness, and their usefulness in preventing adverse
events. Innovative strategies for detection and prevention of HAIs,
Antimicrobial Resistance (AR), and other adverse events are needed to
reduce the morbidity, mortality, and costs associated with these
conditions.
Purpose: The purpose of this research program is to improve
detection, reporting, and prevention of HAIs, AR and other adverse
events in all types of healthcare facilities in the United States. This
program addresses the ``Healthy People 2010'' focus areas 14-20, to
``Reduce hospital-acquired infections in intensive care unit
patients'', and 14-21 to ``Reduce antimicrobial use among intensive-
care unit patients''. For a copy of Healthy People 2010, visit the
Internet site: http://www.health.gov/healthypeople.
Measurable outcomes of the program will be in alignment with the
following performance goal for the National Center for Infectious
Diseases (NCID): Protect Americans from infectious diseases.
Research Objectives:
Nature of the research problem: HAIs, AR and other adverse
events, such as medication errors, cause significant morbidity and
mortality among patients in U.S. healthcare facilities, adding billions
of dollars to the cost of healthcare. However, estimates of the burden
of these adverse events are inexact because surveillance methods are
neither standardized nor uniformly applied throughout the United
States. Furthermore, shortcomings in surveillance at the facility level
impede systematic, patient care quality improvement efforts. Thus,
there is a need to develop uniform, active surveillance methods to
identify and analyze HAIs and other adverse events that compromise
patient safety. In addition, the extent of compliance with infection
control processes, such as hand hygiene, that enhance patient safety
should be monitored. To reduce the incidence and adverse outcomes of
HAIs, such infections need to be monitored systematically and reported
in a standardized way throughout the U.S. healthcare system. Effective
interventions need to be designed to reduce the incidence and severity
of HAIs, AR and other adverse events. These interventions, once
thoroughly evaluated and implemented, need to be exported for long-term
use by prevention programs in a variety of healthcare settings (e.g.,
academic medical centers, small community hospitals, and long-term
acute care facilities) to continually improve the delivery of patient
care. Such prevention strategies need not be limited to acute-care
settings but could be applicable to programs that involve the entire
spectrum of the healthcare delivery system, such as for health
maintenance organizations where many Americans now receive their
healthcare. The resource requirements and impact of all interventions
and prevention activities need to be measured in economic terms.
Scientific knowledge to be achieved through research
supported by this program: This research program will provide the
scientific knowledge to: (1) Develop strategies and methods for
accurately measuring HAIs, AR and other adverse events in healthcare
facilities in the United States, and (2) develop effective
interventions that can be applied in different types of healthcare
settings to reduce the incidence of HAIs, AR and other adverse events
related to medical care.
Objectives of this research program: The objectives of
this program are to: (1) identify and validate direct and/or surrogate
markers for HAIs (e.g., bloodstream infections, pneumonia, surgical
site infections, and urinary tract infections) and processes of care
that are closely linked to HAIs (e.g., sub-optimal hand hygiene, poor
insertion and care of indwelling medical devices, and inappropriate
antibiotic prophylaxis), particularly HAI markers and process of care
measures that can be assessed through automated retrieval, processing,
and analysis of data from electronic health records or other electronic
information systems in use in healthcare institutions; (2) identify and
validate interventions or prevention programs in various healthcare
settings that result in sustained reductions in HAIs, AR and other
adverse events; and (3) develop quantitative estimates of the economic
impact (e.g., cost-effectiveness) of interventions and prevention
programs.
Examples of experimental approaches include: Developing
innovative approaches for case detection and reporting of surgical site
infections (SSIs) such as using (1) clinical electronic data sources
and computer algorithms to detect SSIs in health care settings, and (2)
standard electronic messages to report clinical and laboratory data for
each infection.
Project Organization: This project requires participation
by multiple healthcare facilities in a healthcare system (such as those
that may be affiliated with an academic medical center). Participation
by multiple facilities will allow for more robust validation of
findings and innovations than is possible in a single facility. Each
healthcare system should be comprised of at least 10 free standing
healthcare facilities and should include at least three of the
following types of institutions: academic medical centers that include
adult and pediatric populations, small (100-200 bed) community
hospitals, a health maintenance organization, long-term care
facilities, long-term acute care centers, dialysis units, and
ambulatory surgery centers. The applicants must demonstrate how
multiple facilities within each healthcare system will actively
participate in development and validation of both interventions and
reporting measures. Promising research and development approaches are
encouraged as long as they address each of the three essential areas of
investigation: (1) To identify and validate direct and/or surrogate
markers for HAIs, AR and other adverse events, and processes of care
that can be assessed through automated re-use of data already entered
in electronic health records or other electronic information systems
(including laboratory, administrative, and financial systems); (2)
identification and validation of interventions or multifaceted
prevention programs that reduce infectious adverse events in healthcare
settings and that can be effectively implemented in at least two
different types of healthcare facilities; and (3) development of
quantitative estimates to assess the economic impact (e.g., cost-
effectiveness) of the preventive interventions. Participating project
sites must document institutional commitment; organizational
capabilities; current electronic health record capacity that will
enable automated detection, data collection, and reporting of HAIs, AR
and other adverse events within their healthcare system and
interdisciplinary coordination and collaboration, ability to involve
multiple facilities and facilities of varying types in validating
interventions and reporting measures. Participating project sites must
also document a willingness to collaborate and assist CDC investigators
in
[[Page 49284]]
determining the scope and magnitude of newly emerging infectious
disease threats by conducting rapid surveys of their patient
populations as needed during the funding period.
Awardee Organization: Awardees will be organized into a
consortium. The consortium will be overseen by the Epicenters Program
Steering Committee composed of principal investigators and CDC
representatives. The steering committee will direct coordinate, and
supervise the entire range of scientific project activities, monitor
progress and ensure that the strategic plan is implemented. A well-
developed Program Steering Committee is integral to the Program's
success
Awardee activities for this program are as follows:
Actively participate, as a member of the Epicenters
Steering Committee, in developing, managing, and coordinating the
project activities and ensuring that the strategic plan of the Steering
Committee is implemented.
Identify and validate direct and surrogate markers for
HAIs, particularly those that can be assessed through automated
retrieval, processing, and analysis of data from electronic health
records or other electronic information systems in use in healthcare
institutions. The purpose of developing such markers is to provide
measures that minimize resources required for data collection, have
maximal utility for supporting and evaluating prevention efforts, and
are broadly generalizable and applicable across a wide variety of
institutions.
Identify and validate processes of care that are closely
linked to HAIs, particularly those that can be assessed through
automated retrieval, processing, and analysis of data from electronic
health records or other electronic information systems in use in
healthcare. The purpose of developing such markers is to provide
measures that directly support and guide prevention efforts by
measuring adherence to critical prevention practices. Ideally these
measures should require minimal resources for collection, and should be
broadly generalizable and applicable across a wide variety of
institutions.
Produce quantitative estimates of the economic impact of
interventions and prevention programs. The purpose of these estimates
is to provide quantifiable estimates of the cost-effectiveness of
prevention activities.
Determine the scope and magnitude of newly emerging
infectious disease threats by conducting rapid surveys of their patient
and provider populations as needed during the funding period. The
purpose of this activity is to collaborate with CDC to provide a
mechanism for rapid assessment across a wide variety of U.S. healthcare
institutions of conditions as they relate to newly emerging infectious
disease threats.
In a cooperative agreement, CDC staff is substantially involved in
the program activities, above and beyond routine grant monitoring. CDC
Activities for this program are as follows:
Collaborate, as appropriate, with the recipient in all
stages of the program, and provide programmatic and technical
assistance. A CDC representative will serve as a member of the
Epicenters Program Steering Committee, and in that capacity actively
participate in the management, coordination, and supervision of the
entire range of project activities, as well as monitoring progress and
ensure that the strategic plan is implemented.
Offer assistance to the recipient in all aspects of the
science, including active participation in protocol development.
Participate in improving program performance through
consultation with the recipient based on information and activities of
other projects.
Assist in the development of research protocols for
Institutional Review Board (IRB) review by all cooperating institutions
participating in the research project. The CDC IRB will review and
approve the protocol initially and on at least an annual basis until
the research project is completed.
Participate in the dissemination of findings and
information stemming from the project.
II. Award Information
Type of Award: Cooperative Agreement. CDC involvement in this
program is listed in the Activities Section above.
Mechanism of Support: U01.
Fiscal Year Funds: $2,000,000.
Approximate Current Fiscal Year Funding: $2,000,000.
Approximate Total Project Period Funding: $10,000,000.
This amount is an estimate, and is subject to availability of
funds. This amount includes Direct and Indirect costs.
Approximate Number of Awards: four--five.
Approximate Average Award: $350,000.
This includes Direct an Indirect costs for the first 12 month
budget period.
Floor of Award Range: $300,000.
Ceiling of Award Range: $400,000 total cost for each of five years
of the funding period, which includes direct and indirect costs.
Proposals that exceed this amount for any years of the project will be
considered ineligible and will not be reviewed.
Anticipated Award Date: February 2006.
Budget Period Length: 12 months.
Project Period Length: five years.
Throughout the project period, CDC's commitment to continuation of
awards will be conditioned on the availability of funds, evidence of
satisfactory progress by the recipient (as documented in required
reports), and the determination that continued funding is in the best
interest of the Federal government.
III. Eligibility Information
III.1. Eligible Applicants
Applications may be submitted by public and private nonprofit
organizations.
Public nonprofit organizations
Private nonprofit organizations
Universities
Colleges
Research institutions
Hospitals
Community-based organizations
Faith-based organizations
Federally recognized Indian tribal governments
Indian tribes
Indian tribal organizations
State and local governments or their Bona Fide Agents
(this includes the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, the Commonwealth of the Northern Marianna
Islands, American Samoa, Guam, the Federated States of Micronesia, the
Republic of the Marshall Islands, and the Republic of Palau)
Political subdivisions of States (in consultation with
States)
A Bona Fide Agent is an agency/organization identified by the state
as eligible to submit an application under the state eligibility in
lieu of a state application. If you are applying as a bona fide agent
of a state or local government, you must provide a letter from the
state or local government as documentation of your status. Place this
documentation behind the first page of your application form.
III.2. Cost Sharing or Matching
Matching funds are not required for this program.
III.3. Other
If you request a funding amount greater than the ceiling of the
award range, your application will be considered non-responsive, and
will not
[[Page 49285]]
be entered into the review process. You will be notified that your
application did not meet the submission requirements.
Special Requirements: If your application is incomplete or non-
responsive to the requirements listed in this section, it will not be
entered into the review process. You will be notified that your
application did not meet submission requirements.
Late applications will be considered non-responsive. See
section ``IV.3. Submission Dates and Times'' for more information on
deadlines.
Note: Title 2 of the United States Code Section 1611 states that
an organization described in Section 501(c)(4) of the Internal
Revenue Code that engages in lobbying activities is not eligible to
receive Federal funds constituting an award, grant, or loan.
Individuals Eligible to Become Principal Investigators: Any
individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented
racial and ethnic groups as well as individuals with disabilities are
always encouraged to apply for CDC programs. Additional Principal
Investigator qualifications are as follows:
Knowledge of healthcare infection control practices.
Knowledge of electronic data reporting systems used in
healthcare.
Experience in administering multi-center programs.
IV. Application and Submission Information
IV.1. Address To Request Application Package
To apply for this funding opportunity, use application form PHS 398
(OMB number 0925-0001 rev. 9/2004). Forms and instructions are
available in an interactive format on the CDC Web site, at the
following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.
Forms and instructions are also available in an interactive format
on the National Institutes of Health (NIH) Web site at the following
Internet address: http://grants.nih.gov/grants/funding/phs398/phs398.html
.
If you do not have access to the Internet, or if you have
difficulty accessing the forms on-line, you may contact the CDC
Procurement and Grants Office Technical Information Management Section
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to
you.
IV.2. Content and Form of Application Submission
Letter of Intent (LOI). Your LOI must be written in the following
format:
Maximum number of pages: two
Font size: 12-point unreduced
Double spaced
Paper size: 8.5 by 11 inches
Page margin size: One inch
Printed only on one side of page
Written in plain language, avoid jargon
Your LOI must contain the following information:
Descriptive title of the proposed research
Name, address, E-mail address, telephone number, and FAX
number of the Principal Investigator
Names of other key personnel
Participating institutions
Number and title of this Announcement
Application: Follow the PHS 398 application instructions for
content and formatting of your application. If the instructions in this
announcement differ in any way from the PHS 398 instructions, follow
the instructions in this announcement. For further assistance with the
PHS 398 application form, contact PGO-TIM staff at 770-488-2700, or
contact GrantsInfo, Telephone (301) 435-0714, E-mail:
GrantsInfo@nih.gov.
Your research plan should address activities to be conducted over
the entire project period. As part of the application preparation
process, the applicants must develop a strategic plan and provide a
timeline of planning and priority-setting processes. The purpose of the
strategic plan is to identify unique approaches for measuring HAIs, AR
and adverse events, developing successful interventions and prevention
programs to reduce them, and assessing their cost implications. The
plan must include both short- and long-term goals, and must include
descriptions of objective milestones that will be used to measure
progress. The following framework is suggested for developing the
strategic plan:
Strengths--Identify and describe the strengths of the
application including a brief summary of the research expertise of
participants, description of the current facilities including the
extent to which there is shared common administrative and information
technology infrastructure that will facilitate aggregation of
electronic information and coordination of interventions and/or
prevention programs across facilities, and other research resources
available.
Opportunities--Identify and evaluate the potential
opportunities to establish a high quality research program using
project funds. As part of the planning process, the applicant needs to
include a description of how they will participate in the steering
committee to: Determine which collaborations will be developed,
identify opportunities that utilize the unique strengths within the
healthcare system, and target opportunities that will address the goals
of the project.
Research Theme--The intent of the Epicenter Program is to
support a substantial range of research activities that involve
vibrant, multi-disciplinary approaches that transcend customary
thinking and organizational structures to address critical questions
related to monitoring and prevention of HAIs, AR and other adverse
events. The theme and the range of activities pursued should be clearly
defined as a result of the strategic planning process.
Action Plan--Outline the major approaches to measuring
HAIs, AR and other adverse events to be investigated using project
funds and describe how these research efforts will yield measurable
benefits when they are disseminated and deployed in a variety of other
healthcare institutions in the United States. Develop a detailed
research plan, with milestones, for the first year of funding and
describe overall aims and milestones for subsequent years of funding.
Elements of the action plan should include: Determining what research
projects will be pursued, identifying possible pilot projects for
support as developmental research projects, and defining milestones for
specific products that the project proposes to pursue.
Outcome Measurements--Determine and describe how progress
on the action plan will be measured. Include qualitative and
quantitative criteria for measuring how each participating healthcare
facility provides ``added value'' and for assessing unique
contributions that cannot be provided by other research awards. Define
metrics (both process and outcome measures) for assessing long-term
goals for the entire funding period, and specific, detailed milestones
with timelines for the first year for each project and activity.
Each application must propose a Research Program that includes at
least three research Projects or activities, which together will enable
the Program to contribute significantly to the identification,
reporting, and ultimate prevention or reduction in HAIs, AR and other
adverse events in healthcare institutions. The range of research topics
that may be proposed is outlined above. Each research project must
[[Page 49286]]
include measurable milestones and process and outcome measures, with
timelines, and criteria for assessing success/productivity at periodic
intervals. Applicants are encouraged to consider the scope and range of
research proposed and develop a Research Program that is coherent and
consistent with available resources and personnel.
You are required to have a Dun and Bradstreet Data Universal
Numbering System (DUNS) number to apply for a grant or cooperative
agreement from the Federal government. Your DUNS number must be entered
on line 11 of the face page of the PHS 398 application form. The DUNS
number is a nine-digit identification number, which uniquely identifies
business entities. Obtaining a DUNS number is easy and there is no
charge. To obtain a DUNS number, access http://www.dunandbradstreet.com
or call 1-866-705-5711. For more information, see the CDC Web site at:
http://www.cdc.gov/od/pgo/funding/pubcommt.htm.
This announcement requires summary budget information provided in
the application package along with budget justification and support
must be written in the form, format, and the level of detail as
specified in the budget guidelines. You may access the latest version
of the budget guidelines by accessing the following Web site: http://www.cdc.gov/od/pgo/funding/budgetguide2004.htm
.
Additional requirements that may require you to submit additional
documentation with your application are listed in section ``VI.2.
Administrative and National Policy Requirements.''
IV.3. Submission Dates and Times
LOI Deadline Date: September 22, 2005. CDC requests that you send a
LOI if you intend to apply for this program. Although the LOI is not
required, not binding, and does not enter into the review of your
subsequent application, the LOI will be used to gauge the level of
interest in this program, and to allow CDC to plan the application
review.
Application Deadline Date: October 24, 2005.
Explanation of Deadlines: Applications must be received in the CDC
Procurement and Grants Office by 4 p.m. Eastern Time on the deadline
date. If you submit your application by the United States Postal
Service or commercial delivery service, you must ensure that the
carrier will be able to guarantee delivery by the closing date and
time. If CDC receives your submission after closing due to: (1) Carrier
error, when the carrier accepted the package with a guarantee for
delivery by the closing date and time, or (2) significant weather
delays or natural disasters, you will be given the opportunity to
submit documentation of the carrier's guarantee. If the documentation
verifies a carrier problem, CDC will consider the submission as having
been received by the deadline.
This announcement is the definitive guide on LOI and application
content, submission address, and deadline. It supersedes information
provided in the application instructions. If your application does not
meet the deadline above, it will not be eligible for review, and will
be discarded. You will be notified that you did not meet the submission
requirements.
CDC will not notify you upon receipt of your submission. If you
have a question about the receipt of your application, first contact
your courier. If you still have a question, contact the PGO-TIM staff
at: 770-488-2700. Before calling, please wait two to three days after
the submission deadline. This will allow time for submissions to be
processed and logged.
IV.4. Intergovernmental Review of Applications
Your application is subject to Intergovernmental Review of Federal
Programs, as governed by Executive Order (EO) 12372. This order sets up
a system for state and local governmental review of proposed federal
assistance applications. You should contact your state single point of
contact (SPOC) as early as possible to alert the SPOC to prospective
applications, and to receive instructions on your state's process.
Click on the following link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html
.
IV.5. Funding Restrictions
Restrictions, which must be taken into account while writing your
budget, are as follows:
Funds relating to the conduct of research will not be
released until the appropriate assurances and IRB approvals are in
place.
Reimbursement of pre-award costs is not allowed.
If you are requesting indirect costs in your budget, you must
include a copy of your indirect cost rate agreement. If your indirect
cost rate is a provisional rate, the agreement should be less than 12
months of age.
IV.6. Other Submission Requirements
LOI Submission Address: Submit your LOI by express mail, delivery
service, fax, or E-mail to: Dr. Trudy Messmer, Scientific Review
Administrator, CDC/NCID, 1600 Clifton Road, MS C-19, Atlanta, GA 30333.
Phone: (404) 639-3770. Fax: (404) 639-2469. E-mail: TMessmer@cdc.gov.
Application Submission Address: Submit the original and one hard
copy of your application and appendices by mail or express delivery
service to: Technical Information Management--CI06-001, CDC Procurement
and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
At the time of submission, four additional copies of the
application with appendices must be sent to: Dr. Trudy Messmer--CI06-
001, Scientific Review Administrator, CDC/NCID, 1600 Clifton Road, MS
C-19, Atlanta, GA 30333. Phone: (404) 639-3770. E-mail:
TMessmer@cdc.gov.
Applications may not be submitted electronically at this time.
V. Application Review Information
V.1. Review Criteria
Applicants are required to provide measures of effectiveness that
will demonstrate the accomplishment of the various identified
objectives of the cooperative agreement. Measures of effectiveness must
relate to the performance goals stated in the ``Purpose'' section of
this announcement. Measures must be objective and quantitative, and
must measure the intended outcome. These measures of effectiveness must
be submitted with the application and will be an element of evaluation.
The goals of CDC-supported research are to advance the
understanding of biological systems and health risks, improve the
control and prevention of disease and injury, and enhance health. In
the written comments, reviewers will be asked to evaluate the
application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. The
scientific review group will address and consider each of the following
criteria equally in assigning the application's overall score,
weighting them as appropriate for each application.
The review criteria are as follows:
Significance: Does this proposal address important problems? If the
aims of the application are achieved, what new knowledge will be
available about healthcare-associated infections; AR, other adverse
events in healthcare; and processes to prevent HAIs, AR and adverse
events? What will be the effect of these studies on the concepts or
methods that drive this field?
[[Page 49287]]
Approach: Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate to the
aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative, problem-solving tactics?
Innovation: Does the project employ novel and promising concepts,
approaches or methods? Are the aims original and innovative? Does the
project challenge existing paradigms or develop new methodologies or
technologies?
Investigator: Is the investigator appropriately trained and well
suited to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers
(if any)?
Environment: Does the scientific environment in which the work will
be done contribute to the probability of success? Do the proposed
studies take advantage of unique features of the scientific environment
or employ useful collaborative arrangements? Is there evidence of
institutional support? Is there evidence of previous collaboration
among the facilities included in the application?
Additional Review Criteria: In addition to the above criteria, the
following items will be considered in the determination of scientific
merit and priority score:
All major objectives are addressed.
All three subject areas (HAIs, other adverse events and
processes of care) are addressed.
Presence of a detailed research plan, with measurable and
achievable milestones and process and outcome measures, for the first
year of funding that describes overall aims of the project.
Metrics for assessing long-term goals for the entire
funding period and approximate timelines for subsequent years.
Demonstration of interdisciplinary coordination and
collaboration.
Demonstration of ability to involve multiple facilities of
various types in validating interventions and reporting measures.
Healthcare systems demonstrating the capacity and plans for involving a
large number of facilities in the validation of both interventions and
reporting measures will be given priority. Of particular importance
will be demonstrating prior evidence of multi-facility collaboration
within a healthcare system, or strong evidence for the administrative
capacity to coordinate and standardize intervention and data collection
strategies across a large number of facilities.
Demonstration of an existing capacity for electronic
healthcare recordkeeping and electronic clinical and laboratory data
exchanges within the participating facilities in the healthcare system.
Preference will be given to healthcare systems with shared common
administrative and information technology infrastructure that will
facilitate coordination of data collection and performance of
prevention activities in a standardized fashion.
Knowledge of healthcare infection control practices.
Previous experience in multi-facility and/or multi-center
research studies
Protection of Human Subjects from Research Risks: Federal
regulations (45 CFR Part 46) require that applications and proposals
involving human subjects must be evaluated and reference to the risk to
the subjects, the adequacy of protection against these risks, the
potential benefits of the research to the subjects and others, and the
importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
.
Inclusion of Women and Minorities in Research: Does the application
adequately address the CDC Policy requirements regarding the inclusion
of women, ethnic, and racial groups in the proposed research? This
includes: (1) The proposed plan for the inclusion of both sexes and
racial and ethnic minority populations for appropriate representation;
(2) The proposed justification when representation is limited or
absent; (3) A statement as to whether the design of the study is
adequate to measure differences when warranted; and (4) A statement as
to whether the plans for recruitment and outreach for study
participants include the process of establishing partnerships with
community(ies) and recognition of mutual benefits.
Care and Use of Vertebrate Animals: If vertebrate animals are to be
used in the project, the five items described under section f. of the
PHS 398 research grant application instructions will be assessed.
Budget: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research. The priority
score should not be affected by the evaluation of the budget.
V.2. Review and Selection Process
Applications will be reviewed for completeness by the Procurement
and Grants Office (PGO) and for responsiveness by NCID. Incomplete
applications and applications that are non-responsive to the
eligibility criteria will not advance through the review process.
Applicants will be notified that their application did not meet
submission requirements.
Applications that are complete and responsive to the announcement
will be evaluated for scientific and technical merit by an appropriate
peer review group or charter study section convened by NCID in
accordance with the review criteria listed above. As part of the
initial merit review, all applications may:
Undergo a process in which only those applications deemed
to have the highest scientific merit by the review group, generally the
top half of the applications under review, will be discussed and
assigned a priority score.
Receive a written critique.
Receive a second programmatic level review by CDC senior
staff.
Award Criteria: Criteria that will be used to make award decisions
during the programmatic review include:
Scientific merit (as determined by peer review)
Availability of funds
Programmatic priorities
V.3. Anticipated Award Date
February 2006.
VI. Award Administration Information
VI.1. Award Notices
After the peer review of the application is completed, all
applications will receive a written critique called a summary
statement.
Those applications under consideration for funding will receive a
call or e-mail from the Grants Management Specialist (GMS) of the
Procurements and Grants Office (PGO) for additional information.
A formal notification in the form of a Notice of Award (NoA) will
be provided to the applicant organization. The NoA signed by the Grants
Management Officer (GMO) is the authorizing document. This document
will be mailed and/or emailed to the recipient fiscal officer
identified in the application.
Selection of the application for award is not an authorization to
begin performance. Costs incurred before receipt of the NoA are not
allowed.
VI.2. Administrative and National Policy Requirements
45 CFR Part 74 and Part 92
For more information on the Code of Federal Regulations, see the
National Archives and Records Administration at the following Internet
address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
[[Page 49288]]
The following additional requirements apply to this project:
AR-1 Human Subjects Requirements
AR-2 Requirements for Inclusion of Women and Racial and
Ethnic Minorities in Research
AR-3 Animal Subjects Requirements
AR-6 Patient Care
AR-7 Executive Order 12372
AR-8 Public Health System Reporting Requirements
AR-9 Paperwork Reduction Act Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-14 Accounting System Requirements
AR-15 Proof of Non-Profit Status
AR-16 Security Clearance Requirement
AR-22 Research Integrity
AR-23 States and Faith-Based Organizations
AR-24 Health Insurance Portability and Accountability Act
Requirements
AR-25 Release and Sharing of Data
Additional information on these requirements can be found on the
CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm
.
VI.3. Reporting
You must provide CDC with an original, plus two hard copies of the
following reports:
1. Interim progress report, (use form PHS 2590, OMB Number 0925-
0001, rev. 9/2004 as posted on the CDC Web site) due 90 days before the
end of the budget period.
2. Financial status report, due 90 days after the end of the budget
period.
3. Final financial and performance reports, due 90 days after the
end of the project period.
These reports must be mailed to the Grants Management Specialist
listed in the ``Agency Contacts'' section of this announcement.
VII. Agency Contacts
We encourage inquiries concerning this announcement.
For general questions, contact: Technical Information Management
Section, CDC Procurement and Grants Office, 2920 Brandywine Road,
Atlanta, GA 30341. Telephone: 770-488-2700.
For scientific/research issues, contact: Dr. Trudy Messmer,
Scientific Review Administrator, CDC/NCID, 1600 Clifton Road, MS C-19,
Atlanta, GA 30333. Telephone: (404) 639-3770. E-mail: TMessmer@cdc.gov.
For questions about peer review, contact: Ms. Barbara Stewart,
Public Health Analyst, CDC/NCID, 1600 Clifton Road, MS C-19, Atlanta,
GA 30333. Telephone: (404) 639-3770. E-mail: BStewart@cdc.gov.
For financial, grants management, or budget assistance, contact:
Sharron P. Orum, Grants Management Specialist, CDC Procurement and
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770-
488-2716. E-mail: spo2@cdc.gov.
VIII. Other Information
This and other CDC funding opportunity announcements can be found
on the CDC Web site, Internet address: http://www.cdc.gov. Click on
``Funding'' then ``Grants and Cooperative Agreements.''
Dated: August 17, 2005.
William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention.
[FR Doc. 05-16694 Filed 8-22-05; 8:45 am]
BILLING CODE 4163-18-P