Part I Overview Information


Department of Health and Human Services

Participating Organizations
Centers for Disease Control and Prevention (CDC), (http://www.cdc.gov/)

Components of Participating Organizations
National Center for Infectious Disease (NCID/CDC), (http://www.cdc.gov/ncidod/)

Title: Antimicrobial Resistance

The CDC policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH. 

Authority:
42 U.S.C. 241(a); 42 U.S.C. 247b(k)(2)

Announcement Type
New

Request For Applications (RFA) Number: RFA-CI-06-003

Catalog of Federal Domestic Assistance Number(s)
93.283

CENTERS FOR DISEASE CONTROL AND PREVENTION-INVESTIGATIONS AND TECHNICAL ASSISTANCE.

Key Dates
Release Date: February 3, 2006
Letter of Intent Receipt Date: March 2, 2006
Application Receipt Date: April 3, 2006
Peer Review Date: May-June 2006
Council Review Date: July 2006
Earliest Anticipated Start Date: July 2006
Expiration Date: April 4, 2006

Due Date for E.O. 12372
Due no later than 60 days after the application receipt date.

Additional Overview Content

Executive Summary
Not Applicable

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

Section II. Award Information
  1. Mechanism(s) of Support
  2. Funds Available

Section III. Eligibility Information
  1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
  2.Cost Sharing or Matching
  3.Other - Special Eligibility Criteria

Section IV. Application and Submission Information
  1. Address to Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements

Section V. Application Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
      1. Principal Investigator Rights and Responsibilities
      2. CDC Responsibilities
      3. Collaborative Responsibilities
  3. Reporting

Section VII. Agency Contact(s)
  1. Scientific/Research Contact(s)
  2. Peer Review Contact(s)
  3. Financial/ Grants Management Contact(s)
  4. General Questions Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The CDC and NCID are committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA).  This RFA addresses “Healthy People 2010” priority area(s) of Infectious Disease and is in alignment with NCID performance goal(s) to protect Americans from Infectious Diseases. For more information, see http://www.health.gov/healthypeople and http://www.whitehouse.gov/omb/mgmt-gpra/.

The problem of antimicrobial resistance continues to worsen while few new, and fewer still, novel, antimicrobials are presently in the drug development pipeline. With the need for preventing antimicrobial resistance growing ever greater, the full spectrum of prevention measures must be utilized including not only reducing unnecessary antimicrobial use but also preventing the transmission of resistance. New methods to prevent transmission of antimicrobial resistant pathogens, as well as greater understanding of the efficacy and relative effectiveness of existing transmission prevention methods, are needed. In addition, new understanding of the epidemiology of antimicrobial resistance transmission is needed with identification of “weak links” in the chain of transmission where new or existing control measures could be best employed. 

The purpose of this Request for Applications (RFA) is two fold:  The development of new methods to prevent transmission of Antimicrobial Resistant (AR) pathogens (R01) and reducing Community-Associated Methicillin-Resistant Staphylococcus aureus (CA-MRSA) Infection in households (U01). 

Purpose:

The purpose of the R01 award is to develop novel method(s) for controlling transmission of antimicrobial resistant bacterial pathogens with the intent of interrupting transmission to such a degree that rates of infection due to antimicrobial resistant pathogens are favorably impacted, the overall health of the population is improved, and healthcare cost savings are realized. In addition, to develop innovative applications of existing control measures and assess the relative effectiveness (including cost effectiveness) of novel and existing methods for controlling transmission of antimicrobial resistant bacterial pathogens. Finally, to advance our understanding of how antimicrobial resistant bacterial pathogens are most commonly transmitted between human hosts with the objective of discovering key points in the chain of transmission that would be most amenable to interruption via prevention measures.

Research Objectives:

R01 Grant

The main control measures emphasized to date focus upon preventing unnecessary exposure of the population to antimicrobial use. Although several initiatives for improving the prudent or rational use of antimicrobials have demonstrated modest benefits in controlling resistance, further efforts need to include preventing the other principal factor responsible for increasing incidence of antimicrobial resistant infections, namely transmission.

Novel methods of implementing and assessing existing infection control measures should be developed. An assessment of control measures should include measures of safety, sustainability, and effectiveness including cost effectiveness relative to the excess costs of treating antimicrobial resistant infections.

In some cases the epidemiology of colonization, transmission, and disease pathogenesis may need to be investigated with the goal of discovering “weak links” in the chain of transmission that could be exploited through application of novel or existing control measures. Such control measures could include personal (e.g. hand or skin) or environmental (e.g. surfaces) hygiene measures, isolation and barrier precautions, or other measures in addition to personal hygiene that could eradicate colonization or reduce dissemination during infection.

The ultimate goal of the research should be the development, implementation, and assessment of more effective methods for interrupting direct and indirect contact transmission. Examples of pathogens within the scope of this program include, but are not limited to: Methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), multi-drug resistant gram negative bacteria, and drug resistant Clostridium difficile. Non-bacterial antimicrobial resistant pathogens (e.g. viruses), pathogens transmitted via the airborne route (e.g. tuberculosis), sexual transmission, and foodborne transmission are outside the scope of this program. Following the development of a vaccine that is now having a significant, favorable impact on transmission and disease caused by drug-resistant Streptococcus pneumoniae, this organism is also currently considered outside the scope of this program. The human population investigated and the setting where they are investigated will depend upon wherever a particular pathogen is commonly transmitted. Examples include children in daycare settings, inmates of correctional facilities, members of contact sports teams, military recruits, or patients in a healthcare system. Examples of settings where patients in a healthcare system may be investigated include acute care hospitals, long term care facilities, ambulatory/outpatient facilities, and home care environments.         

The specific objectives for the RO1 award include the following:

1.  Develop novel method(s) for controlling transmission of antimicrobial resistant bacterial pathogens.

2.  Assess the relative effectiveness (including cost effectiveness) of the novel methods developed and existing methods for controlling transmission of antimicrobial resistant bacterial pathogens.

3.  Advance our understanding of how antimicrobial resistant bacterial pathogens are most commonly transmitted between human hosts.

The recipient of the R01 award will be responsible for all of the following activities:

1. Assemble a network of partners (a consortium) to accomplish the objectives of the program announcement, including identification and access to a defined population of persons within which there is colonization and disease caused by the antimicrobial resistant pathogen(s) of interest and data sufficiently prevalent to allow appropriate analyses.

2. Propose or invent novel infection control methods or the novel application of existing methods and be able to implement and assess their effectiveness in the study population. Aspects of assessment will need to include the means to detect colonization, identify infections and clinical outcomes, perform strain typing of antimicrobial pathogens, and perform cost and safety evaluations.

The purpose of the U01 award is the identification of an intervention that effectively prevents community-associated—MRSA (CA-MRSA) infection within household units that have evidence of multiple CA-MRSA infections clustered in space and time.

U01 Cooperative Agreement:

1. Evaluate the impact of an educational initiative on the prevention of S. aureus transmission and infection within households that have demonstrated evidence of multiple CA-MRSA infections clustered in space and time.

2.  Compare the impact of education alone versus education plus topical antimicrobial therapy for colonization eradication on the subsequent incidence of CA-MRSA infections within household units.

3.  Better define the epidemiology of S. aureus colonization and disease within household units (clustering, frequency, contributing factors, etc.)

The ultimate goal of the research will be to measure the impact of topical antimicrobial therapy as an intervention among households with evidence of ongoing CA-MRSA transmission. It is anticipated that the project can best be accomplished in partnership with a large health maintenance organization (HMO) or other managed care entity that provides both healthcare services and insurance coverage to its members, and that has an information technology infrastructure that allows the use of existing electronic databases to monitor details of all healthcare encounters among its members (including diagnosis codes, laboratory data, pharmacy data, demographic data for both inpatient and outpatient healthcare encounters). One proposed approach to the problem could be as follows, although applicants are encouraged to suggest modifications or alternative approaches that will accomplish the objectives:

1. Adapt existing educational materials targeting both clinicians and patients regarding prevention of S. aureus transmission in households and other settings, and implement a program for use of these educational materials by both clinicians and patients in whom community-associated S. aureus infection is identified.

2. Using these educational materials, conduct a randomized controlled trial to test the following hypothesis: In households that have evidence of CA MRSA infections clustered in time, preventive education plus simultaneous treatment of all household members with a topical decolonizing regimen (e.g. 5-day course intranasal mupirocin plus daily chlorhexidine baths) will result in a greater decrease in subsequent adverse events attributable to CA-MRSA compared to education alone.

3. Recipient will recruit household cohorts to participate in the trial. An example of eligibility criteria might include household units with >1 resident, all of whom are enrollees in the partnership managed care organization or HMO.  Eligible household units might also meet at least one of the following criteria: 1) one member with documented CA-MRSA skin/soft tissue infection plus a history of at least one other household member having recent skin/soft tissue infection (not necessarily documented by a healthcare visit), or 2) >1 household member with documented CA-MRSA infection closely clustered in time, or 3) single member with recurrent CA-MRSA infections clustered in time.

4. Outcome Measures could include the following: subsequent CA-MRSA infections per household member, subsequent healthcare visits per household member (overall and for skin/soft tissue infection), subsequent antibiotic courses per household member. A secondary outcome measure might include the impact of education alone by examining the incidence of household clustering in the entire HMO cohort before and after introduction of the educational campaign targeting all patients with community-acquired S. aureus infection.

Each applicant may submit only one application for this RFA.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use both the R01 and UO1 award mechanism(s).

As an applicant for the R01, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The CDC U01 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with CDC staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

The participating CIO NCID intends to commit approximately $1,000,000 for both direct and indirect costs in FY 2006 to fund 3-5 awards for the R01 grant. The average award amount will be $200,000 for both direct and indirect costs and is for each budget period. An applicant may request a project period of up to 3 years. An applicant may request up to $300,000 for both direct and indirect costs.  The approximate total budget period funded amount is $200,000, and the Approximate Total Project Period Funding Amount is $1,000,000. The anticipated start date for new awards is July 2006.

The participating CIO NCID intends to commit approximately $1,300,000 for both direct and indirect costs in FY2006 to fund 1 award for the U01 grant.  The average award amount will be $300,000 for both the direct and indirect costs for the first 12 months.  An applicant may request a project period of up to 3 years.  An applicant may request up to $300,000 for the first 12 months.  The approximate total budget period funded amount for years 2 and 3 is $500,000 for each year, and the approximate total project period funding amount is $1,300,000.  The anticipated state date for the new award is July 2006.

All estimated funding amounts are subject to availability of funds.

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.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

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.

1.B. Eligible Individuals

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.

2. Cost Sharing or Matching

Cost sharing or matching of funds is not required.

The most current Grants Policy Statement can be found at:
http://grants.nih.gov/grants/policy/policy.htm

3. Other-Special Eligibility Criteria

If your application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered into the review process.

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.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

CDC Telecommunications for the hearing impaired: TTY 770-488-2783.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a Dun & Bradstreet (D&B) Data Universal Numbering System number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Put the award mechanism you are applying for at the end of the project title on the face page of the PHS398.

3. Submission Dates and Times

All requested information must be received in the CDC Procurement and Grants Office by 4:00 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 described in Section IV.3.A, it will not be eligible for review, and will be discarded. You will be notified that you did not meet the submission requirements.

Otherwise, 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-TIMS 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.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: March 2, 2006
Application Receipt Date(s):  April 3, 2006
Peer Review Date: May - June 2006
Council Review Date: July2006
Earliest Anticipated Start Date: July 2006

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A

The letter of intent should be sent to:

Dr. M. Chris Langub
Office of Public Health Research
Office of the Chief of Science
Centers for Disease Control and Prevention
1600 Clifton Road
Atlanta, GA 30333
Telephone: (404-639-4640
FAX: (404) 639-4903
Email: MLangub@cdc.gov

3.B. Sending an Application

Applications follow the PHS 398 application instructions for content and formatting of your applications.  If the instructions in this announcement differ in any way from the PHS 398 instructions, follow the instructions in this announcement.

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application and all appendices, including the checklist, and one signed photocopy in one package to:

Technical Information Management Section – RFA CI06-003

CDC, Procurements and Grants Office
2920 Brandywine Road
Atlanta, GA  30341

At the time of submission, four additional copies of the application, including the appendix material, must be sent to:

Dr. M. Chris Langub
Office of Public Health Research
Office of the Chief of Science
Centers for Disease Control and Prevention
1600 Clifton Road
Atlanta, GA  30333
Telephone: (404) 639-4640
FAX: (404) 639-4903
Email: MLangub@cdc.gov

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness and responsiveness by NCID and PGO.  Incomplete and non-responsive applications will not be reviewed.

4. Intergovernmental Review

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

5. Funding Restrictions

 All CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the PHS Grants Policy Statement.

Restrictions, which must be taken into account while writing your budget, are as follows:

6. Other Submission Requirements

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.  "Award Administration Information".

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. 

Your research plan should address activities to be conducted over the entire project period.

Plan for Sharing Research Data  

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://www.cdc.gov/od/pgo/funding/ARs.htm under Additional Requirements 25 Release and Sharing of Data. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

PHS policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (PHS Grants Policy Statement http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs.)  Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://www.cdc.gov/od/pgo/forminfo.htm).  See Section VI.3. Reporting.  

Section V. Application Review Information


1. Criteria 

The following will be considered in making funding decisions:

Information regarding the R01 grant awards: Because a federally-funded initiative is currently underway to evaluate the effectiveness of active surveillance and isolation of MRSA- and VRE-colonized hospital inpatients, a proposal that duplicates this effort for these organisms would not be expected to score favorably.  However, proposals that offer significant new innovation or variation on MRSA and/or VRE control in the healthcare setting are encouraged.

Because there will also be a U01 cooperative agreement award funded under this announcement dealing with limiting transmission of CA-MRSA within households through education and topical antimicrobial decolonization, a proposal that duplicates this effort for this organism would not be expected to score favorably.  However, proposals that would offer additional innovation or variation with regard to the control of MRSA in community settings are encouraged.

R01 projects must address all of the three objectives listed above. The focus of this research program is on antimicrobial resistant bacterial pathogens that are of particular public health importance. This would infer that multi-drug resistant pathogens, difficult to treat pathogens or pathogens for which few therapeutic options exist will be viewed as the priority for funding.

Awards will be prioritized according to a spectrum of resistant pathogens studied:  i.e., there may be only one award for each of the resistant pathogens considered to be of programmatic importance.

Information regarding the U01 cooperative agreement award:  Preference for funding will be given to U01 applicants that are healthcare systems that provide both healthcare services and insurance coverage to its members (examples include, but are not limited to, large heath maintenance organizations [HMOs] or other managed care entities) and meet the following criteria: 1) large, well-defined patient member cohort residing in regions where there is significant CA-MRSA activity 2), integrated information technology infrastructure that allows use of existing electronic databases to monitor details of all healthcare encounters for all cohort members over time (including diagnosis codes, laboratory data, pharmacy data, demographic data for both inpatient and outpatient healthcare encounters), and 3) large proportion of cohort lives in households where all members of the household unit receive their healthcare through the applicant managed care provider. The applicant must provide written documentation of their ability to meet the above criteria.

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCID in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of CDC-supported research are to advance the understanding of health promotion and prevention of disease, injury, and disability, and enhance preparedness.  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. 

 Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators 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? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

 In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

U01 Additional Review Criteria: In addition to the above criteria, the following will be considered in the determination of scientific merit and priority score:  How well does the applicant demonstrate the existence of an integrated information technology infrastructure that allows use of existing electronic databases to monitor the entire healthcare experience for all individuals over time (detailed diagnosis codes, laboratory data, pharmacy data, demographic data for every inpatient and outpatient encounter) and to collect the data necessary for the study? How well does the applicant demonstrate a large, well defined patient cohort residing in regions where there is significant CA-MRSA activity? How well does the applicant demonstrate that a large proportion of its covered members live in households where all members of the household unit are covered members? How well does the applicant demonstrate that the frequency of CA-MRSA clustering within family units is sufficient to provide adequate statistical power to answer the proposed research questions?

Protection of Human Subjects from Research Risk:
The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398, http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.) Additional CDC Requirements under AR-1 Human Subjects Requirements can be found on http://www.cdc.gov/od/pgo/funding/ARs.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 in Research:
If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed. Additional CDC Requirements under AR-3 Animal Subjects Requirements can be found on .

2.B. Additional Review Considerations

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.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

PHS policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs. Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590 http://www.cdc.gov/od/pgo/forminfo.htm). See Section VI.3. Reporting.

2. Anticipated Announcement and Award Dates

Anticipated award date, July 2006.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

Those applicants under consideration for funding will be contacted by CDC 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.  Any cost incurred before receipt of the NoA is at the recipient’s risk.  These costs may be reimbursed only to the extent considered allowable pre-award costs.  See also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

The Code of Federal Regulations 45 CFR Part 74 and Part 92 have details about policy requirements.  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. Additional requirements can be found in Section VIII. Other Information of this document or on the CDC website at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm. These will be incorporated into the NoA by reference.
 
2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and CDC grant administration policies.

One of the administrative and funding instrument used for this program will be the cooperative agreement U01 an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial CDC programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the CDC purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the CDC as defined above.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for:

U01 Development and Implementation of educational campaign

In partnership with CDC, the recipient will adapt existing educational materials for use in the project.  The clinician-targeted materials should focus on recognition, diagnosis, and therapeutic approach to S. aureus infections, and should emphasize the clinician role in patient education regarding prevention of transmission. The patient targeted materials will be intended for use by all patients with community-acquired S. aureus infection, and will provide guidance for preventing S. aureus transmission in households and other settings where close contact might be expected.

Protocol Development

In partnership with CDC, the recipient will develop the study protocol. This will include an analysis plan for the intervention trial and the overall impact of educational intervention in the study population.

Conduct a pilot study

In collaboration with CDC, a pilot study will be conducted in order to optimize study recruitment and implementation procedures, and to confirm estimates of the incidence of disease in the recipient patient population. A sample population of patients will be screened for eligibility, and, with consent, nasal swabs will be obtained from all household members to determine the prevalence of colonization among eligible households.  The pilot can help determine whether individual testing of each family member will be required routinely, or whether prevalence of colonization among members of households with evidence of clustering is high enough to warrant a more practical approach of empirically treating all members of eligible households rather than testing each individual for colonization.

Conduct study

Recruit and enroll sufficient household cohorts to complete the trial based upon sample size estimate derived from data collected during the pilot study.  Collect all necessary baseline and outcome data necessary for analysis.

S. aureus isolates

Save all S. aureus isolates from enrolled households for testing for resistance to topical agents used in the study. (e.g. mupirocin and chlorhexidine)

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and CDC policies.

2.A.2. CDC Responsibilities

A CDC Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

CDC will collaborate with recipient in all phases of study development, implementation, analysis, and reporting. CDC will also conduct laboratory analysis of S. aureus isolates collected during the course of the study, including susceptibility testing.

Additionally, an agency program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

3. Reporting

You must provide CDC with an original, plus two hard copies of the following reports:

  1. Interim/Grant Progress Report, (use form PHS 2590, OMB Number 0925-0001, rev. 9/04 as posted on the CDC website) no less than 120 days prior to the end of the current budget period.  The progress report will serve as your non-competing continuation application.
  2. Annual Progress Report, due 90 days after the end of the budget period.
  3. Financial status report, no more than 90 days after the end of the budget period.
  4. Final financial and performance reports, no more than 90 days after the end of the project period.

These reports must be forward by U.S. Postal Service or Express Delivery to the Grants Management Specialist listed in the “Agency Contacts” section of this announcement.

Although the financial plans of the CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon 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.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Dr. Trudy Messmer
Office of Extramural Research
National Center for Infectious Diseases
Coordinating Center for Infectious Diseases
Centers for Disease Control and Prevention
1600 Clifton Road, MS C-19
Atlanta, GA  30333
Telephone: (404) 639-3770
FAX: (404) 639-2469
Email: TMessmer@cdc.gov

2. Peer Review Contacts:
 
Dr. M. Chris Langub
Office of Public Health Research
Office of the Chief of Science
Centers for Disease Control and Prevention
1600 Clifton Road
Atlanta, GA  30333
Telephone: (404) 639-4640
FAX: (404) 639-4903
Email: MLangub@cdc.gov

3. Financial or Grants Management Contacts:

Ms. Sharron Orum
Grants Management Specialist
Procurement and Grants Office
Centers for Disease Control and Prevention
2920 Brandywine Road
Atlanta, GA  30341
Telephone: (770) 488-2716
Email: SOrum@cdc.gov

4. General Questions Contacts:

Technical Information Management Section
CDC Procurement and Grants Office
2920 Brandywine Road
Atlanta, GA  30341
Telephone:  770-488-2700
Email: PGOTIM@cdc.gov

Section VIII. Other Information


Required Federal Citations

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks 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).   Additional CDC Requirements under AR-1 Human Subjects Requirements can be found on http://www.cdc.gov/od/pgo/funding/ARs.htm.

Use of Animals in Research:
Recipients of PHS support for activated involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.  Additional CDC Requirements under AR-3 Animal Subjects Requirements can be found on http://www.cdc.gov/od/pgo/funding/ARs.htm.

Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research
It is the policy of the Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC/ATSDR-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995.

Executive Order 12372 Review
Applications are subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (E.O.) 12372. The order sets up a system for State and local governmental review of proposed Federal assistance applications. Applicants should contact their State single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications and to receive instructions on the State process. For proposed projects serving more than one State, the applicant is advised to contact the SPOC for each State affected.
Click on the following link to get the current SPOC list http://www.whitehouse.gov/omb/grants/spoc.html.

Indian tribes must request tribal government review of their applications.

SPOCs or tribal governments that have recommendations about an application submitted to CDC should send them, in a document bearing the program announcement number, no more than 60 days after the application deadline date, to:

Sharron Orum, Grants Management Specialist
Procurement and Grants Office
Announcement Number RFA CI06-003
Centers for Disease Control and Prevention (CDC)
2920 Brandywine Road
Atlanta, Georgia 30341-4146

CDC does not guarantee to accept or justify its non-acceptance of recommendations that are received more than 60 days after the application deadline.

Public Health System Reporting Requirements
This program is subject to the Public Health System Reporting Requirements. Under these requirements, all community-based non-governmental organizations submitting health services applications must prepare and submit the items identified below to the head of the appropriate State and/or local health agency(s) in the program area(s) that may be impacted by the proposed project no later than the application deadline date of the Federal application. The appropriate State and/or local health agency is determined by the applicant. The following information must be provided:

A. A copy of the face page of the application (SF 424).

B. A summary of the project that should be titled "Public Health System Impact Statement" (PHSIS), not exceed one page, and include the following:

  1. A description of the population to be served.

  2. A summary of the services to be provided.

  3. A description of the coordination plans with the appropriate state and/or local health agencies.

If the State and/or local health official should desire a copy of the entire application, it may be obtained from the State Single Point of Contact (SPOC) or directly from the applicant.

Smoke-Free Workplace Requirements
CDC strongly encourages all recipients to provide a smoke-free workplace and to promote abstinence from all tobacco products. Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, or early childhood development services are provided to children.

Healthy People 2010
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.whitehouse.gov/omb/grants/spoc.html.

Lobbying Restrictions
Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.

In addition no part of CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.

Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.

The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation

It remains permissible to use CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.

Recipients of CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of CDC funds should give close attention to isolating and separating the appropriate use of CDC funds from non-CDC funds. CDC also cautions recipients of CDC funds to be careful not to give the appearance that CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.

Prohibition on Use of CDC Funds for Certain Gun Control Activities
The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act specifies that: "None of the funds made available for injury prevention and control at the Centers for Disease Control and Prevention may be used to advocate or promote gun control."

Anti-Lobbying Act requirements prohibit lobbying Congress with appropriated Federal monies. Specifically, this Act prohibits the use of Federal funds for direct or indirect communications intended or designed to influence a member of Congress with regard to specific Federal legislation. This prohibition includes the funding and assistance of public grassroots campaigns intended or designed to influence members of Congress with regard to specific legislation or appropriation by Congress.

In addition to the restrictions in the Anti-Lobbying Act, CDC interprets the language in the CDC's Appropriations Act to mean that CDC's funds may not be spent on political action or other activities designed to affect the passage of specific Federal, State, or local legislation intended to restrict or control the purchase or use of firearms.

Accounting System Requirements
The services of a certified public accountant licensed by the State Board of Accountancy or the equivalent must be retained throughout the project as a part of the recipient's staff or as a consultant to the recipient's accounting personnel. These services may include the design, implementation, and maintenance of an accounting system that will record receipts and expenditures of Federal funds in accordance with accounting principles, Federal regulations, and terms of the cooperative agreement or grant.

Capability Assessment
It may be necessary to conduct an on-site evaluation of some applicant organization's financial management capabilities prior to or immediately following the award of the grant or cooperative agreement. Independent audit statements from a Certified Public Accountant (CPA) for the preceding two fiscal years may also be required.

Proof of Non-profit Status
Proof of nonprofit status must be submitted by private nonprofit organizations with the application. Any of the following is acceptable evidence of nonprofit status: (a) a reference to the applicant organization's listing in the Internal Revenue Service's (IRS) most recent list of tax-exempt organizations described in section 501(c)(3) of the IRS Code; (b) a copy of a currently valid IRS tax exemption certificate; (c) a statement from a State taxing body, State Attorney General, or other appropriate State Official certifying that the applicant organization has a nonprofit status and that none of the net earnings accrue to any private shareholders or individuals; (d) a certified copy of the organization's certificate of incorporation or similar document that clearly establishes nonprofit status; (e) any of the above proof for a State or national parent organization and a statement signed by the parent organization that the applicant organization is a local nonprofit affiliate.

Security Clearance Requirement
All individuals who will be performing work under a grant or cooperative agreement in a CDC-owned or leased facility (on-site facility) must receive a favorable security clearance, and meet all security requirements. This means that all awardee employees, fellows, visiting researchers, interns, etc., no matter the duration of their stay at CDC must undergo a security clearance process.

Small, Minority, And Women-owned Business
It is a national policy to place a fair share of purchases with small, minority and women-owned business firms. The Department of Health and Human Services is strongly committed to the objective of this policy and encourages all recipients of its grants and cooperative agreements to take affirmative steps to ensure such fairness. In particular, recipients should:

  1. Place small, minority, women-owned business firms on bidders mailing lists.
  2. Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services.
  3. Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms.
  4. Use the assistance of the Minority Business Development Agency of the Department of Commerce, the Office of Small and Disadvantaged Business Utilization, DHHS, and similar state and local offices.

Research Integrity
The signature of the institution official on the face page of the application submitted under this Funding Opportunity Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.

The regulation places requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity (http://ori.hhs.gov./policies/statutes.shtml).

For example:
Section 93.301 Institutional assurances.(a) General policy. An institution with PHS supported biomedical or behavioral research, research training or activities related to that research or research training must provide PHS with an assurance of compliance with this part, satisfactory to the Secretary. PHS funding components may authorize [[Page 28389]] funds for biomedical and behavioral research, research training, or activities related to that research or research training only to institutions that have approved assurances and required renewals on file with ORI. (b) Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution-- (1) Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct; and (2) Complies with its own policies and procedures and the requirements of this part.

Compliance with Executive Order 13279
Faith-based organization are eligible to receive federal financial assistance, and their applications are evaluated in the same manner and using the same criteria as those for non-faith-based organizations in accordance with Executive Order 13279, Equal Protection of the Laws for Faith-Based and Community Organizations.  All applicants should, however, be aware of restrictions on the use of direct financial assistance from the Department of Health and Human Services (DHHS) for inherently religious activities. Under the provisions of Title 45, Parts 74, 87, 92 and 96, organizations that receive direct financial assistance from DHHS under any DHHS program may not engage in inherently religious activities, such as worship, religious instruction, or proselytization as a part of the programs or services funded with direct financial assistance from DHHS.  If an organization engages in such activities, it must offer them separately, in time or location, from the programs or services funded with direct DHHS assistance, and participation must be voluntary for the beneficiaries of the programs or services funded with such assistance.  A religious organization that participates in the DHHS funded programs or services will retain its independence from Federal, State, and local governments, and may continue to carry out its mission, including the definition, practice, and expression of its religious beliefs, provided that it does not use direct financial assistance from DHHS to support inherently religious activities such as those activities described above.  A faith-based organization may, however, use space in its facilities to provide programs or services funded with financial assistance from DHHS without removing religious art, icons, scriptures, or other religious symbols.  In addition, a religious organization that receives financial assistance from DHHS retains its authority over its internal governance, and it may retain religious terms in its organizations name, select its board members on a religious basis, and include religious references in its organizations mission statements and other governing documents in accordance with all program requirements, statutes, and other applicable requirements governing the conduct of DHHS funded activities.  For further guidance on the use of DHHS direct financial assistance see Title 45, Code of Federal Regulations, Part 87, Equal Treatment for Faith-Based Organizations, and visit the internet site:

Health Insurance Portability and Accountability Act Requirements
Recipients of this grant award should note that pursuant to the Standards for Privacy of Individually Identifiable Health Information promulgated under the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may disclose protected health information to public health authorities authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions.  The definition of a public health authority includes a person or entity acting under a grant of authority from or contract with such public agency.  CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and CDC will provide successful recipients a specific grant of public health authority for the purposes of this project.

Release and Sharing of Data
The Data Release Plan is the Grantee's assurance that the dissemination of any and all data collected under the CDC data sharing agreement will be released as follows:

a. In a timely manner.

b. Completely, and as accurately as possible.

c. To facilitate the broader community.

d. Developed in accordance with CDC policy on Releasing and Sharing Data.

April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003, http://www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) http://www.4.law.cornell.edu/uscode/5/5/552/html.

Applications must include a copy of the applicant's Data Release Plan.  Applicants should provide CDC with appropriate documentation on the reliability of the data.  Applications submitted without the required Plan may be ineligible for award.  Award will be made when reviewing officials have approved an acceptable Plan.  The successful applicant and the Program Manager will determine the documentation format.  CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality. 


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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