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 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:

○ co-develop chart abstraction form.

○ co-develop consent forms and questionnaire for interviews.

○ verify participating institutions meet criteria to fulfill study objectives.

○ participate in pilot-testing of data collection instruments.

Provide scientific and technical assistance:

○ serve as subject matter resource on CA-MRSA during development, implementation, and needed modifications to the study.

○ provide administrative assistance for interactions with CDC funding mechanisms.

Provide laboratory support:

○ develop protocol for appropriate collection and transportation of CA-MRSA isolates.

○ provide molecular epidemiologic classification of CA-MRSA isolates using CDC Staphylococcus Pulsenet.

○ provide toxin testing of staphylococcus isolates.

○ provide reference antimicrobial susceptibility testing.

○ provide technical and scientific laboratory.

Collaborate on development of CA-MRSA prevention and control methods

○ participate with recipient on selection of antiseptics for use in the intervention step of the study.

○ develop educational materials for use with families and study participants.

○ co-develop instruments for measuring effectiveness of prevention methods.

Collaborate in communicating findings of the study

○ compile epidemiologic and laboratory findings for full analysis.

○ perform univariate and multivariate analysis of collected data.

○ 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

○ 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.

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. 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-PA#04101, 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.
• 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.