[Federal Register: April 26, 2004 (Volume 69, Number 80)]
[Notices]
[Page 22523-22527]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ap04-72]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Assessing Transmission and Prevention of Community-Associated
MRSA Infection Among Children, Family Members, and Close Contacts
Announcement Type: New.
Funding Opportunity Number: 04101.
Catalog of Federal Domestic Assistance Number: 93.283.
Key Dates:
Letter of Intent Deadline: May 11, 2004.
Application Deadline: June 25, 2004.
I. Funding Opportunity Description
Authority: Sections 317(k)(2) of the Public Health Service Act,
[42 U.S.C. 247b(k)(2)], as amended.
Purpose: The purpose of this study is to determine interventions
that are effective for controlling and preventing spread of community-
associated-methicillin resistant Staphylococcus aureus (CA-MRSA) in
families and settings where children are at risk for acquiring CA-MRSA
(e.g., day care centers). Many health departments are currently
receiving requests from parents and day care centers for guidance on
controlling and preventing MRSA infections. This program addresses the
``Healthy People 2010'' focus area of Immunization and Infectious
Diseases.
Measurable outcomes of the program will be in alignment with the
following performance goal for the National Center for Infectious
Diseases (NCID): To reduce the spread of antimicrobial resistance.
Research Objectives: The objectives of this study are to:
Determine the role of family members and close
contacts of infected children in the transmission of CA-MRSA.
Determine effectiveness of different
interventions in controlling and preventing CA-MRSA among family
members and close contacts of children infected with CA-MRSA.
Activities: Awardee activities for this program are as follows:
Identify cases of CA-MRSA infection among
children less than six years old using laboratory findings.
Administer a questionnaire to participating
case-patients, family members, and close contacts (including members of
a case-patient's day care center classroom) to identify potential risk
factors for acquisition of CA-MRSA and to identify current or prior
infection possibly due to CA-MRSA.
Assess participant's perceptions about MRSA
disease, infection control, and general hygiene behaviors.
Perform a carriage study of participants to
determine rates of colonization of Staphylococcus aureus.
Evaluate the effectiveness of two possible
interventions: (1) Only education (basic hygiene, appropriate wound
care, bandage handling, basic
[[Page 22524]]
infection control and disease recognition), or (2) education plus use
of antiseptic soaps and washes (e.g., chlorhexidine) for personal
hygiene use by case-patients, their families, and their contacts to
prevent transmission.
Perform a follow-up survey to: (1) Assess
changes on participants perceptions about MRSA disease, infection
control and general hygiene behaviors; (2) assess perceptions of the
effectiveness of the intervention and; (3) identify problems associated
with its implementation.
Perform a follow-up colonization survey among
participants to determine the effect of the intervention on carriage of
Staphylococcus aureus.
Monitor case-patients, family members, and close
contacts to determine any subsequent infections with CA-MRSA.
Collect all Staphylococcus aureus isolates from
carriage studies and all CA-MRSA infections from children, family
members, and contacts. Confirm bacterial identification, antimicrobial
susceptibility testing, pulsed-field gel electrophoresis types, and
toxin characterization of isolates.
Analyze S. aureus pulsed-field types using
PulseNet-BioNumerics program.
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 with recipient on study design and protocol
development:
[cir] co-develop chart abstraction form.
[cir] co-develop consent forms and questionnaire for interviews.
[cir] verify participating institutions meet criteria to fulfill
study objectives.
[cir] participate in pilot-testing of data collection instruments.
Provide scientific and technical assistance:
[cir] serve as subject matter resource on CA-MRSA during
development, implementation, and needed modifications to the study.
[cir] provide administrative assistance for interactions with CDC
funding mechanisms.
Provide laboratory support:
[cir] develop protocol for appropriate collection and
transportation of CA-MRSA isolates.
[cir] provide molecular epidemiologic classification of CA-MRSA
isolates using CDC Staphylococcus Pulsenet.
[cir] provide toxin testing of staphylococcus isolates.
[cir] provide reference antimicrobial susceptibility testing.
[cir] provide technical and scientific laboratory.
Collaborate on development of CA-MRSA prevention and control
methods
[cir] participate with recipient on selection of antiseptics for
use in the intervention step of the study.
[cir] develop educational materials for use with families and study
participants.
[cir] co-develop instruments for measuring effectiveness of
prevention methods.
Collaborate in communicating findings of the study
[cir] compile epidemiologic and laboratory findings for full
analysis.
[cir] perform univariate and multivariate analysis of collected
data.
[cir] present findings at national conferences and in peer-reviewed
journals.
Collaborate in translation of study findings to policy and
recommendations for prevention and control of CA-MRSA
Participate in improving program performance through consultation
and visits with recipient
[cir] periodically evaluate to determine that appropriate study
targets are being met in a timely manner.
Collaborate with recipient to modify study components in response
to problems encountered
Facilitate communication of data and results among stakeholders.
Assist in the development of research protocols for 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.
II. Award Information
Type of Award: Cooperative Agreement.
CDC involvement in this program is listed in the Activities Section
above.
Fiscal Year Funds: 2004.
Approximate Total Funding: $104,000.
Approximate Number of Awards: One.
Approximate Average Award: $104,000 (This amount is for the first
12-month budget period, and includes both direct and indirect costs).
Floor of Award Range: None.
Ceiling of Award Range: $104,000.
Anticipated Award Date: July 1, 2004.
Budget Period Length: 12 months.
Project Period Length: Three 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:
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).
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 be entered into the review process. You will be notified that
your application did not meet the submission 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.
This program is designed and intended to support research,
therefore only research will be supported under this cooperative
agreement. Any applications proposing anything other research will be
considered non-responsive.
An LOI is required for this program. Any application received
without the prior submission of an LOI will be considered non-
responsive.
Eligibility is limited to state and local governments participating
or able to participate in the CDC Staphylococcus PulseNet protocol for
PFGE, a capability only available to state and local health departments
at present. PulseNet is a nationwide database of S. aureus strain types
and other strain characteristics, maintained at CDC, to monitor trends
in the types and virulence mechanisms of S. aureus isolated in the
United States.
[[Page 22525]]
Programmatic Priorities (Applicant should possess the following
qualifications):
Successful history of PFGE typing and use of CDC
Staphylococcus Pulsenet protocol in a state or local health department.
A library of available PFGE patterns of Staphylococcus aureus isolates
from the prior years would be preferable.
Close collaboration with a large healthcare
provider to ensure successful collection of case-patient data and
appropriate identification and handling of S. aureus isolates.
History of successful studies in day care
centers.
Documented proportion of pediatric CA-MRSA of
all MRSA of greater than 40 percent.
Working collaboration with microbiology
laboratories, such as a laboratory network for identifying CA-MRSA
cases in different geographic and demographic settings.
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.
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.
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. 5/2001). 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): A letter of intent is required for this
Program Announcement and 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, and telephone
number of the Principal Investigator.
Names of other key personnel.
Participating institutions.
Number and title of this Program Announcement
(PA).
Application: Follow the PHS 398 application instructions for
content and formatting of your application. 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, and should be no more than 20 pages in
length.
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 PA uses just-in-time concepts. It also uses the modular
budgeting as well as non-modular budgeting formats. See: http://grants.nih.gov/grants/funding/modular/modular.htm
for additional
guidance on modular budgets. Specifically, if you are submitting an
application with direct costs in each year of $250,000 or less, use the
modular budget format. Otherwise, follow the instructions for non-
modular budget research grant applications.
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: May 11, 2004. Submission of an LOI is required
if you intend to apply for this program. The LOI will not be evaluated
or scored. It will be used to gauge the level of interest in this
program and to allow CDC to plan the application review. If you do not
submit an LOI, you will not be allowed to submit an application.
Application Deadline Date: June 25, 2004.
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 send your application by the United States Postal Service
or commercial delivery service, you must ensure that the carrier will
be able to guarantee delivery of the application by the closing date
and time. If CDC receives your application 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 carriers guarantee. If the documentation
verifies a carrier problem, CDC will consider the application as having
been received by the deadline.
This announcement is the definitive guide on application 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 your application did not meet the
submission requirements.
CDC will not notify you upon receipt of your application. 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 application deadline. This will allow time for applications 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.
[[Page 22526]]
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: None
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: Machel Forney, Public Health Analyst,
Division of Healthcare Quality Promotion, National Center for
Infectious Diseases, Centers for Disease Control and Prevention, 57
Executive Park Drive South, Room 5015, Mailstop A-07, Atlanta, GA
30329, Telephone: 404-498-1174, E-mail: MForney@cdc.gov.
Application Submission Address: Submit the original and five hard
copies of your application by mail or express delivery service to:
Technical Information Management-PA04101, CDC Procurement and
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
Applications may not be submitted electronically at this time.
V. Application Review Information
V.1. Criteria
You 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, 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.
Your application will be evaluated against the following criteria:
1. Background/Need (40 points)
Does the applicant demonstrate a strong understanding of the need
to determine interventions that are effective for controlling and
preventing spread of community-associated-MRSA in families? Does the
applicant illustrate the need for this project? Does the applicant
present a clear goal for this project? Has the applicant provided
evidence of existing skill and success using molecular epidemiologic
techniques (i.e., Staphylococcus PulseNet protocol) for characterizing
methicillin-resistant Staphylococcus aureus? Has the applicant
demonstrated that the proposed population under study has a high
prevalence of community-associated methicillin-resistant Staphylococcus
aureus among pediatric population?
2. Capacity (20 Points)
Does the applicant demonstrate that it has the expertise,
facilities, and other resources necessary to accomplish the program
requirements? Has the applicant provided evidence of existing
infrastructure for surveillance for antimicrobial-resistant organisms?
Has the applicant provided evidence of successful studies in pediatric
settings such as day care centers or pediatric clinics? Has the
applicant demonstrated a working collaboration with microbiology
laboratories, such as a laboratory network for identifying CA-MRSA
cases in different geographic and demographic settings? Has the
applicant demonstrated existing close collaboration with a large
healthcare provider to ensure successful collection of case-patient
data and appropriate identification and handling of Staphylococcus
aureus isolates.
3. Operational Plan (15 Points)
Does the applicant present clear, time-phased objectives that are
consistent with the stated program goal and a detailed operational plan
outlining specific activities that are likely to achieve the objective?
Does the plan clearly outline the responsibilities of each of the key
personnel?
4. Inclusion of Women and Minorities in Research (5 Points)
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.
5. Evaluation Plan (10 Points)
Does the applicant present a plan for monitoring progress toward
the stated goals and objectives?
6. Measures of Effectiveness (10 Points)
Does the applicant provide Measures of Effectiveness that will
demonstrate the accomplishment of the various identified objectives of
the cooperative agreement? Are the measures objective/quantitative and
do they adequately measure the intended outcome?
7. Budget (Not Scored)
Does the applicant present a detailed budget with a line-item
justification and any other information to demonstrate that the request
for assistance is consistent with the purpose and objectives of this
grant program?
8. Human Subjects (Not Scored)
Does the application adequately address the requirements of Title
45 CFR Part 46 for the protection of human subjects?
V.2. Review and Selection Process
Applications will be reviewed for completeness by the Procurement
and Grants Office (PGO), and for responsiveness by National Center for
Infectious Diseases. 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.
An objective review panel will evaluate complete and responsive
applications according to the criteria listed in the ``V.1. Criteria''
section above.
In addition, the following factors may affect the funding decision:
Though eligible participants are encouraged to submit an application, a
funding preference will be given to potential applicants that:
Provide evidence of existing skill and success
using molecular epidemiologic techniques (i.e., Staphylococcus PulseNet
protocol) for characterizing methicillin-resistant Staphylococcus
aureus.
Provide evidence of existing infrastructure for
surveillance for antimicrobial-resistant organisms.
[[Page 22527]]
Provide evidence of successful studies in
pediatric settings such as day care centers or pediatric clinics.
Demonstrate that the proposed population under
study has a high prevalence of community-associated methicillin-
resistant Staphylococcus aureus among pediatric population.
Demonstrate a working collaboration with
microbiology laboratories, such as a laboratory network for identifying
CA-MRSA cases in different geographic and demographic settings.
Demonstrate existing close collaboration with a
large healthcare provider to ensure successful collection of case-
patient data and appropriate identification and handling of
Staphylococcus aureus isolates.
V.3. Anticipated Announcement and Award Dates
Anticipated award date is July 1, 2004.
VI. Award Administration Information
VI.1. Award Notices
Successful applicants will receive a Notice of Grant Award (NGA)
from the CDC Procurement and Grants Office. The NGA shall be the only
binding, authorizing document between the recipient and CDC. The NGA
will be signed by an authorized Grants Management Officer, and mailed
to the recipient fiscal officer identified in the application.
Unsuccessful applicants will receive notification of the results of
the application review by mail.
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.
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-7 Executive Order 12372.
AR-9 Paperwork Reduction Act Requirements.
AR-10 Smoke-Free Workplace Requirements.
AR-11 Healthy People 2010.
AR-12 Lobbying Restrictions.
AR-22 Research Integrity.
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. 5/2001 as posted on the CDC website) no less than 90 days
before the end of the budget period. The progress report will serve as
your non-competing continuation application, and must contain the
following elements:
a. Current Budget Period Activities Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activity Objectives.
d. Budget.
e. Additional Requested Information.
f. Measures of Effectiveness.
2. Financial status report and annual progress report, no more than
90 days after the end of the budget period.
3. Final financial and performance reports, no more than 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
For general questions about this announcement, contact: Technical
Information Management Section, CDC Procurement and Grants Office, 2920
Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2700.
For program technical assistance, contact: Dan Jernigan, M.D.,
Division of Healthcare Quality Promotion, National Center for
Infectious Diseases, Centers for Disease Control and Prevention, 1600
Clifton Road, NE., Mailstop A-35, Atlanta, GA 30333, Telephone: 404-
639-2621, E-mail: DJernigan@cdc.gov.
For financial, grants management, or budget assistance, contact:
Jeff Napier, Grants Management Officer, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: (770) 488-
2628, E-mail: JNapier@cdc.gov.
Dated: April 19, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-9373 Filed 4-23-04; 8:45 am]
BILLING CODE 4163-18-P