[Federal Register Volume 70, Number 162 (Tuesday, August 23, 2005)]
[Notices]
[Pages 49282-49288]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-16694]


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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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> Offer assistance to the recipient in all aspects of the 
science, including active participation in protocol development.
    <bullet> Participate in improving program performance through 
consultation with the recipient based on information and activities of 
other projects.
    <bullet> 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.
    <bullet> 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.
    <bullet> Public nonprofit organizations
    <bullet> Private nonprofit organizations
    <bullet> Universities
    <bullet> Colleges
    <bullet> Research institutions
    <bullet> Hospitals
    <bullet> Community-based organizations
    <bullet> Faith-based organizations
    <bullet> Federally recognized Indian tribal governments
    <bullet> Indian tribes
    <bullet> Indian tribal organizations
    <bullet> 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)
    <bullet> 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.
    <bullet> 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:
    <bullet> Knowledge of healthcare infection control practices.
    <bullet> Knowledge of electronic data reporting systems used in 
healthcare.
    <bullet> 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:
    <bullet> Maximum number of pages: two
    <bullet> Font size: 12-point unreduced
    <bullet> Double spaced
    <bullet> Paper size: 8.5 by 11 inches
    <bullet> Page margin size: One inch
    <bullet> Printed only on one side of page
    <bullet> Written in plain language, avoid jargon
    Your LOI must contain the following information:
    <bullet> Descriptive title of the proposed research
    <bullet> Name, address, E-mail address, telephone number, and FAX 
number of the Principal Investigator
    <bullet> Names of other key personnel
    <bullet> Participating institutions
    <bullet> 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:  
<a href="/cdn-cgi/l/email-protection#86c1f4e7e8f2f5cfe8e0e9c6e8efeea8e1e9f0"><span class="__cf_email__" data-cfemail="783f0a19160c0b31161e1738161110561f170e">[email protected]</span></a>.
    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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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:
    <bullet> Funds relating to the conduct of research will not be 
released until the appropriate assurances and IRB approvals are in 
place.
    <bullet> 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: <a href="/cdn-cgi/l/email-protection#03574e6670706e6671436067602d646c75"><span class="__cf_email__" data-cfemail="287c654d5b5b454d5a684b4c4b064f475e">[email protected]</span></a>.
    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: 
<a href="/cdn-cgi/l/email-protection#eebaa38b9d9d838b9cae8d8a8dc0898198"><span class="__cf_email__" data-cfemail="a2f6efc7d1d1cfc7d0e2c1c6c18cc5cdd4">[email protected]</span></a>.
    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:
    <bullet> All major objectives are addressed.
    <bullet> All three subject areas (HAIs, other adverse events and 
processes of care) are addressed.
    <bullet> 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.
    <bullet> Metrics for assessing long-term goals for the entire 
funding period and approximate timelines for subsequent years.
    <bullet> Demonstration of interdisciplinary coordination and 
collaboration.
    <bullet> 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.
    <bullet> 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.
    <bullet> Knowledge of healthcare infection control practices.
    <bullet> 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:
    <bullet> 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.
    <bullet> Receive a written critique.
    <bullet> 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:
    <bullet> Scientific merit (as determined by peer review)
    <bullet> Availability of funds
    <bullet> 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:
    <bullet> AR-1 Human Subjects Requirements
    <bullet> AR-2 Requirements for Inclusion of Women and Racial and 
Ethnic Minorities in Research
    <bullet> AR-3 Animal Subjects Requirements
    <bullet> AR-6 Patient Care
    <bullet> AR-7 Executive Order 12372
    <bullet> AR-8 Public Health System Reporting Requirements
    <bullet> AR-9 Paperwork Reduction Act Requirements
    <bullet> AR-10 Smoke-Free Workplace Requirements
    <bullet> AR-11 Healthy People 2010
    <bullet> AR-12 Lobbying Restrictions
    <bullet> AR-14 Accounting System Requirements
    <bullet> AR-15 Proof of Non-Profit Status
    <bullet> AR-16 Security Clearance Requirement
    <bullet> AR-22 Research Integrity
    <bullet> AR-23 States and Faith-Based Organizations
    <bullet> AR-24 Health Insurance Portability and Accountability Act 
Requirements
    <bullet> 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: <a href="/cdn-cgi/l/email-protection#67332a0214140a02152704030449000811"><span class="__cf_email__" data-cfemail="a1f5ecc4d2d2ccc4d3e1c2c5c28fc6ced7">[email protected]</span></a>.
    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: <a href="/cdn-cgi/l/email-protection#d39180a7b6a4b2a1a793b0b7b0fdb4bca5"><span class="__cf_email__" data-cfemail="efadbc9b8a988e9d9baf8c8b8cc1888099">[email protected]</span></a>.
    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: <a href="/cdn-cgi/l/email-protection#d1a2a1bee391b2b5b2ffb6bea7"><span class="__cf_email__" data-cfemail="483b38277a082b2c2b662f273e">[email protected]</span></a>.

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


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