[Federal Register Volume 69, Number 80 (Monday, April 26, 2004)]
[Notices]
[Pages 22523-22527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-9373]


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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: 
[email protected].
    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: [email protected].
    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: [email protected].
    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: [email protected].

    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