dd12-005 foa final amendment 1 01.04.12.doc

Amendment 1 01/06/2012:

Bullet point six for Objective 1 under Research Objectives and Approach in Section I was amended to clarify development of a protocol for referring women for diagnosis and possible treatment.

Table of Contents

Part 1. Overview Information Part 2. Full Text of the Announcement Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 1. Overview Information

Announcement Type

New

Key Dates Publication Date

12/09/2011 To receive notification of any changes to RFA-DD-12-005, return to the synopsis page of this announcement at www.grants.gov and click on the “Send Me Change Notification Emails” link. An email address is needed for this service.

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note: HHS/CDC grant submission procedures do not provide a period of time beyond the application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#ar7 for details.

Required Application Instructions It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 25 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348 Part 2. Full Text

Section I. Funding Opportunity Description

Statutory Authority

This program is authorized under Section 301a and Section 317C of the Public Health Service Act.

Purpose The purpose of this research is to learn how to more effectively change behaviors related to Cytomegalovirus Virus (CMV) transmission among pregnant women in order to reduce the incidence of congenital CMV infection. The research will be carried out in settings providing prenatal care with the intent of developing an effective intervention that will be both acceptable to clinic staff and feasible to implement as part of routine clinical prenatal care.

The project will enroll pregnant women in a research study where they will be screened to see if they have CMV antibodies and will be counseled on how to prevent infection. The Screening and Brief Intervention (SBI) will explain how to prevent the most common route of CMV transmission—child-to-mother—by presenting strategies for keeping the child’s urine and saliva from getting in the mother’s eyes, nose, or mouth.

This program addresses the “Healthy People 2020” focus area(s) of Maternal, Infant and Child Health (MICH) as follows:

· MICH-1.6 Reduce the rate of fetal and infants deaths related to birth defects.

· MICH-10.2 Early and adequate prenatal care.

For more information see http://healthypeople.gov.

The proposed research aligns with the goal of the National Center on Birth Defects and Developmental Disabilities to prevent major birth defects attributable to maternal risk factors.

Background Congenital CMV is a leading cause of birth defects and developmental disabilities in the U.S. Each year more than 5,000 children are born with or develop hearing loss, vision loss, intellectual disability (i.e., mental retardation) or other serious sequelae caused by congenital CMV.

The fetus can acquire CMV in utero when the mother has a primary (i.e., first) CMV infection, a reinfection with a different CMV strain, or a CMV reactivation. Pregnant women most commonly acquire CMV infection through contact with the bodily fluids of young children. They may also acquire CMV infection from adults through kissing or sex.

There is evidence that maternal infection may be prevented through education and behavioral change. A recent study in France demonstrated that a screening and brief intervention (SBI), focusing on behaviors such as frequent hand washing, not kissing young children on the mouth, and not sharing food or drink with young children, lowered rates of CMV infection among pregnant women (Vauloup-Fellous, J Clin Virol, 2009)1.

Each year in the U.S., approximately 30,000 women become infected with CMV for the first time during pregnancy (Colugnati, BMC Infect Dis, 2007)2. If CMV Screening and Brief Intervention (SBI) were a routine part of clinical prenatal care, and had similar effectiveness to the France intervention, more than 10,000 new CMV infections could be prevented in pregnant women each year. This could result in at least 1,000 fewer cases of CMV-related disabilities each year in the U.S.

Scientific Knowledge to Be Achieved

Research is needed to develop tailored, scientifically validated interventions to reduce CMV infections among pregnant women. It is anticipated that this project will build on CDC’s research on CMV transmission routes and prevention messaging to develop an intervention that can be used as part of routine clinical care to:

1) Increase knowledge among pregnant women of congenital CMV, transmission routes, and prevention measures.

2) Increase protective behaviors and decrease risk behaviors related to CMV transmission during pregnancy.

3) Identify facilitators and barriers health care providers experience in implementing a clinic-based SBI for CMV.

The intent is to use what is learned from this project to implement larger interventions that can be evaluated not only for their impact on knowledge and behaviors, but also on CMV infection rates in pregnant women.

Research Objectives and Approach This project will build on existing research to develop and test a clinic-based intervention to increase knowledge of and change behaviors related to CMV transmission. The intervention will be targeted at pregnant women in a prenatal clinic setting. Enrollment should take place in at least two clinical sites. The intervention should include demographic subgroups that have a higher risk of congenital CMV, such as adolescent African-American women or Mexican American women (Kharrazi, J Peds, 2010)3. The intervention should combine or adapt intervention approaches or methodologies that have proven promising for preventing CMV infection in pregnant women, especially via the child-to-mother transmission route. All pregnant women will be eligible since most have exposures to young children, even if they are not parents of young children. The intervention should use or adapt communication materials that have been audience tested, such as those created by the CDC. The intervention should be able to be integrated into ongoing prenatal services rather than existing as a stand-alone intervention.

Objective 1: Develop a prenatal clinic-based CMV screening and brief intervention (SBI) that promotes CMV prevention behaviors among pregnant women.

· Enroll women at their first prenatal visit so that they will be identified as early as possible in their pregnancies.

· Develop a protocol to determine CMV serostatus, including IgG, IgM, and IgG avidity tests which together can identify seronegative women, seropositive women with recent infections, and seropositive women without recent infections.

· Identify appropriate laboratory testing facilities.

· Draft and produce detailed intervention materials, including but not limited to intervention manuals and test results counseling.

· Adapt existing prevention materials such as brochures and videos from CDC and other sources.

· Develop a protocol for referring women for diagnosis and possible treatment (e.g., CMV hyperimmune globulin) when appropriate.

· Develop a protocol for referring women for diagnosis and management. Keeping in mind that there is an ongoing clinical trial to evaluate the role of CMV hyperimmune globulin (HIG) in the prevention of vertical transmission, patients may be referred to one of the centers involved in the trial if appropriate.

· Recruit and train staff to deliver the intervention.

Proposed intervention components/content should include, but not be limited to:

· The promotion of behaviors that reduce child-to-mother CMV transmission risk, such as not sharing food or drink, not kissing on the mouth, washing hands after exposures to urine or saliva, etc.

· Prevention counseling that is personalized to each woman’s CMV serostatus, keeping in mind that seropositive women are at risk for reinfection and should also receive the intervention.

Objective 2: Evaluate the efficacy of the intervention for the following outcomes: knowledge of CMV transmission and prevention measures, increased protective behaviors, and decreased risk behaviors.

· Determine an appropriate sample size, with a minimum sample size of 100 enrolled in the study.

· Determine an appropriate length for follow up for each woman that provides a minimum follow-up period of 12 weeks during pregnancy.

· Determine how to measure knowledge and behavioral change, such as surveys, interviews, diaries, direct observation, etc.

· Develop the research protocol for the study to evaluate the intervention and submit the protocol for human subjects review. The suggested timeline to prepare and submit the protocol is 9 months.

· Develop and pilot test assessment instruments

· Develop manual of operations for the conduct of the study

· Implement the intervention and collect data to evaluate the intervention. Although the timeline depends on the number of participants to power the study, all outcome data should be collected at least 6 months prior to the end of the project period to allow for analyses.

· Assess possible adverse consequences associated with the SBI, such as anxiety or stress.

· Evaluate intervention processes, including whether the intervention was executed according to plan, the quality of the implementation, etc.

The research proposed to evaluate the intervention should use a rigorous design (e.g., randomized experimental design) and must include a comparison group that receives the standard of care services in the clinics in which the intervention is being implemented, with the exception that a brochure on CMV may be included with materials given to pregnant women if the standard of care services does not include information on CMV. Women in the comparison group will not be screened for CMV.

Objective 3: Assess the feasibility of the SBI and provide recommendations for implementing the intervention on a larger scale to measurably reduce CMV infection rates among pregnant women.

· Compile qualitative and/or quantitative feedback from patients, providers, and administrators to assess facilitators and barriers to making the CMV SBI feasible as part of routine clinical practice.

· Identify strategies to facilitate stakeholder engagement (e.g., state and local involvement and input throughout the project lifecycle).

References

1. Vauloup-Fellous C, Picone O, Cordier A-G, et al. Does hygiene counseling have an impact on the rate of CMV primary infection during pregnancy? Results of a 3-year prospective study in a French hospital. J Clin Virol. 2009;46S:S49-S53.

2. Colugnati FA, Staras SA, Dollard SC, Cannon MJ. Incidence of cytomegalovirus infection among the general population and pregnant women in the United States. BMC Infect Dis. 2007;7:71.

3. Kharrazi M, Hyde T, Young S, Amin MM, Cannon MJ, Dollard SC. Use of Screening Dried Blood Spots for Estimation of Prevalence, Risk Factors, and Birth Outcomes of Congenital Cytomegalovirus Infection. J Pediatr. 2010;157(2):191-197.

Section II. Award Information

Application Types Allowed

New

The NIH OER Glossary (http://grants.nih.gov/grants/glossary.htm) and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

Total funds available for the entire program are $500,000. One award will be issued for this FOA. The funding amount may be up to $250,000 (Direct and Indirect) each year of the project.

Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Throughout the project period, CDC's commitment to continuation of awards will be conditional 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.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants Eligible Organizations

Higher Education Institutions:

· Public/State Controlled Institutions of Higher Education

· Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

· Hispanic-serving Institutions

· Historically Black Colleges and Universities (HBCUs)

· Tribally Controlled Colleges and Universities (TCCUs)

· Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

· Nonprofits (Other than Institutions of Higher Education)

For- Profit Organizations

· Small Businesses

· For-Profit Organizations (Other than Small Businesses)

Governments

· State Governments

· County Governments

· City or Township Governments

· Special District Governments

· Indian/Native American Tribal Governments (Federally Recognized)

· Indian/Native American Tribal Governments (Other than Federally Recognized)

· Eligible Agencies of the Federal Government

· U.S. Territory or Possession

Other

· Independent School Districts

· Public Housing Authorities/Indian Housing Authorities

· Native American tribal organizations (other than Federally recognized tribal governments)

· Faith-based or Community-based Organizations

· Regional Organizations

· Bona Fide Agents

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 applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via www.grants.gov.

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not eligible to apply.

Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

· Central Contractor Registration (CCR) – must maintain current registration in CCR to be renewed annually.

· Grants.gov

· eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Central Contractor Registration and Universal Identifier Requirements

All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the Central Contractor Registry (CCR) and maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. CCR is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the CCR internet site at www.ccr.gov (https://www.bpn.gov/ccr/default.aspx).

If an award is granted, the grantee organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the grantee organization.

Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization 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 HHS/CDC support.

2. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html).

3. Other Additional Information on Eligibility Eligible applicants must have evidence of access to two or more clinic sites that meet the criteria listed below (Items 1 and 2). Evidence of access to patients should be in the form of letters or written agreements with the proposed clinic sites that are included in the Appendix of the application. Evidence of clinic assignments and expertise on congenital CMV must be placed in the Senior/Key Person Profile section of the application (Items 3 and 4 below).

Eligible applicants must meet the following criteria:

1. Provide evidence of access to a total of at least 500 patients in a 6-month period receiving prenatal care during pregnancy to ensure enrollment of at least 100 patients in the study.

2. Provide evidence that the clinical sites provide access to patients with a range of ages (including 15-24 years) and race/ethnicities.

3. The study team should include at least one member who is on the staff at each clinic site.

4. The study team should include at least one member with demonstrated expertise on congenital CMV.

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

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

If more than one application is submitted by an institution, they must indicate a complete separate title for each application they are submitting in number 11 of the SF424 (R&R) Application Guide “Descriptive Title of Applicant’s Project”.

As defined in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html), applications received in response to the same funding opportunity announcement generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity from www.Grants.gov.

If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 or Email: pgotim@cdc.gov for further instruction Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Standard Time. CDC Telecommunications for the hearing impaired or disable is available at: TTY 1-888-232-6348.

If the applicant encounters technical difficulties with Grants.gov, the applicant should contact Grants.gov Customer Service. The Grants.gov Contact Center is available 24 hours a day, 7 days a week, with the exception of all Federal Holidays. The Contact Center provides customer service to the applicant community. The extended hours will provide applicants support around the clock, ensuring the best possible customer service is received any time it is needed. You can reach the Grants.gov Support Center at 1-800-518-4726 or by email at support@grants.gov. Submissions sent by email, fax, CD’s or thumb drives of applications will not be accepted.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000), except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components. These forms can be downloaded and uploaded as Attachment A from the following link: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm Letter of Intent 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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this funding opportunity

The letter of intent should be sent to:

Joyner Sims, PhD

Scientific Program Official

Extramural Research Program Office

Centers for Disease Control and Prevention

4770 Buford Hwy, NE

Mailstop F-46 Atlanta, GA 30341

Telephone: (770) 488-3043

E-mail: JSims2@cdc.gov Required and Optional Components

A complete application has many components, both required and optional. The forms package associated with this FOA in Grants.gov includes all applicable components for this FOA, required and optional.

Research Plan Components/Attachments

The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consist of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). See Part I, Section 5.5 of the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000) for additional information. Please attach applicable sections of the following Research Plan components:

1. Introduction to Application

2. Specific Aims

3. Research Strategy

4. Inclusion Enrollment Report

5. Progress Report Publication List

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

8. Targeted/Planned Enrollment Table

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

The Research Plan narrative is comprised of components 2, 3, and 4 above. Component 4 (Inclusion Enrollment Report) applies only to renewal and revision applications for clinical research. Note that the Research Strategy is divided into three parts: 1) Significance, 2) Innovation, and 3) Approach.

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.pdf) must be followed, with the following additional instructions: Add text in the space below (before Appendix) to supply any additional instructions related to the Research Plan, but only include information that is different from application guide.

The applicants’ research plan(s) should address activities they will conduct over the entire project period and must include the following items.

Introduction/Background

· Describe the demographics (e.g., age, race/ethnicity) of the patients served by the clinics where the intervention will be implemented and evaluated.

· Describe the clinic sites. Include description of the prenatal services provided to the target population at the proposed clinical sites. Describe the staffing and number of women who access prenatal services in a six-month period.

· Describe research team’s experience doing clinical research with pregnant women. Include experience with studies designed to evaluate interventions.

· Describe research team’s experience working within the clinic sites where the intervention will be implemented and evaluated, including clinical experience of proposed staff.

· Describe research team’s experience gathering quantitative and qualitative feedback from populations via surveys, interviews, focus groups, etc.

· Demonstrate capacity to enroll a minimum of 100 women who are coming in for their first prenatal visit.

· Describe experience retaining patients in follow-up studies. Include steps taken to locate patients that are lost to follow-up.

· Provide letters of support from proposed clinical sites. In addition to a commitment to collaborate, the letter of support should identify proposed roles for clinical staff.

Specific Aims

· Specify overall aims or objectives for intervention development and evaluation.

Research Strategy

· Define CMV prevention strategies to be promoted in the proposed clinic-based intervention (i.e., behavioral guidelines), indicating whether there will be an order of preference (e.g., hierarchy) for promoting or emphasizing particular guidelines (e.g., hand washing vs. avoiding oral transmission).

· Describe behavioral change theory or theories upon which the intervention will be based.

· Describe intervention content and the approach for adapting audience-tested communication materials from CDC and other sources such as brochures, videos, or podcasts to present that content.

· Describe how evidence-based strategies will be used to support intended outcomes.

· Describe how the proposed intervention approaches or methodologies will be integrated into ongoing services at the proposed clinical sites.

· Describe whether and how the proposed intervention will appeal to the target population.

· Identify tasks and a timeline for key intervention and protocol development activities for the two year project. Include milestones and/or measurable outputs that will be used to indicate progress toward having all intervention materials produced and an Institutional Review Board (IRB)-approved protocol within the first 9 months of the project.

· Describe approach to finalizing intervention parameters, including intervention outcomes, intervention approaches or methodologies to be combined and intervention content. Describe the role of the research team’s previous research, the literature, best practices, stakeholders and the target population in finalizing these parameters.

· Provide information on sample size calculations for the evaluation study. The study should be powered with respect to the behavioral change outcome. The anticipated minimum sample size is approximately 100 women, with potentially higher sample sizes needed depending on study design, expected effect size, and expected frequency of baseline knowledge and behaviors.

· Describe approach for recruitment and retention of the target population

· Describe the evaluation design, level of rigor (e.g., experimental, quasi-experimental), method for assignment to intervention and control, and number of follow-up assessments and length of follow-up.

· Describe method of data collection and management.

· Provide a timeline for conducting follow-up assessments and collecting knowledge and behavioral data at a baseline and at subsequent time points during a minimum follow-up period of 12 weeks.

· Describe how study data will be analyzed to determine the efficacy of the intervention using appropriate statistical methods.

· Describe plans to share de-indentified data with CDC for analyses

· Describe expected changes in knowledge and behavioral outcomes associated with the proposed intervention (i.e., specify baseline and post-intervention rates of knowledge and behaviors related to CMV transmission).

· Describe expected contributions to the field (e.g., further understanding of CMV prevention among pregnant women, potential for dissemination to and sustainability of the proposed intervention in prenatal clinics).

· Describe what methods will be used to evaluate patient, provider, and administrative needs for making the CMV SBI feasible as part of routine clinical prenatal care, including approaches such as surveys or interviews.

· Describe strategies to facilitate stakeholder engagement (e.g., state and local involvement and input throughout the project lifecycle).

Staffing

· Describe experience and expertise of key proposed staff, including ability to analyze data and publish in peer-reviewed journals.

· Provide evidence of a clear management and staffing plan for intervention and protocol development, intervention implementation, and evaluation including data collection, data management and data analysis.

· Include in the budget planned travel each year to an annual meeting in Atlanta, GA.

Appendix

Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Page Limitations All page limitations described in this individual FOA must be followed. For this FOA, the

Research Strategy component of the Research Plan narrative is limited to 25 pages.

Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 35 pages for all appendices.

Format for Attachments

Designed to maximize system-conducted validations, multiple separate attachments are required for a complete application. When the application is received by the agency, all submitted forms and all separate attachments are combined into a single document that is used by peer reviewers and agency staff.

CDC require all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide (Part I, Section 2) (http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000).

Failure to follow these requirements may lead to rejection of the application during agency validation or delay in the review process.

3. Submission Dates and Times Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov (http://www.grants.gov/), the online portal to find and apply for grants across all Federal agencies. The eRA Commons systems retrieve the application from Grants.gov and check the application against CDC business rules. If no errors are found, the application will be assembled in the eRA Commons for viewing by the applicant before moving on for further CDC processing.

If errors are found, the applicant will be notified in the eRA Commons. They must make required changes to the local copy of their application and submit again through Grants.gov. Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Once you can see your application in the Commons, be sure to review it carefully as this is what the reviewer will see. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123).

Information on the submission process is provided in the SF424 (R&R) Application Guide.

Note: HHS/CDC grant submission procedures do not provide a period of time beyond the grant application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e. error correction window).

The application package is not complete until it has passed the Grants.gov/eRA Commons validation process. This process and email notifications of receipt, validation or rejection may take two (2) business days.

Applicants are strongly encouraged to allocate additional time prior to the submission deadline to submit their applications and to correct errors identified in the validation process. Applicants are encouraged also to check the status of their application submission to determine if the application packages are complete and error-free. Applicants who encounter system errors when submitting their applications must attempt to resolve them by contacting the Grants.gov Contact Center (1-800-518-4726; support@grants.gov). If the system errors cannot be resolved, applicants must contact CDC PGO TIMS for guidance at least 3 calendar days before the deadline date.

4. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11142).

5. Funding Restrictions All HHS/CDC awards are subject to the terms and conditions, cost principles, and other requirements described in the HHS Grants Policy Statement.

Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

6. Other Submission Requirements and Information

Application Submission

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11144).

Important reminders:

All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to CDC.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

Applicants are reminded to enter the approved Federal Wide Assurance (FWA) that the applicant has on file with the Office for Human Research Protections, if available. If the applicant has a FWA number, enter the 8-digit number. Do not enter the FWA before the number. If a Project/Performance Site is engaged in research involving human subjects, the applicant organization is responsible for ensuring that the Project/Performance Site operates under and appropriate Federal Wide Assurance for the protection of human subjects and complies with 45 CFR Part 46 and other CDC human subject related policies described in Part II of this Application Guide and in the HHS Grants Policy Statement.

See more resources to avoid common errors and submitting, tracking, and viewing applications: http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm or http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm Upon receipt, applications will be evaluated for completeness by the CDC Procurement and Grants Office (PGO) and responsiveness by PGO and the Center, Institute or Office of the CDC. Applications that are incomplete and/or nonresponsive will not be reviewed.

Section V. Application Review Information

1. Criteria Only the review criteria described below will be considered in the review process. As part of the CDC mission (http://www.cdc.gov/about/organization/mission.htm), all applications submitted to the CDC in support of public health research are evaluated for scientific and technical merit through the CDC peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

· Does the applicant demonstrate a solid understanding of congenital CMV and CMV transmission during pregnancy?

· Does the applicant provide a theory or model of behavioral change upon which the intervention will be based?

· Does the applicant identify and describe influences on CMV transmission risk, such as protective or risk behaviors, among pregnant women in the US?

· Does the proposed intervention address key influences on behavior identified by the applicant? To what extent are the intervention approaches and content likely to modify the key influences and behaviors?

· Is the proposed intervention scalable (e.g., could it be integrated into other clinical settings, what resources would be needed by other clinics to implement the intervention)?

· Does the applicant provide a comprehensive approach to studying feasibility of implementing a CMV SBI in a clinical setting?

· Are the proposed project activities likely to have a positive impact on the field of CMV prevention among pregnant women in the US? To what extent are the expected changes in behaviors substantively significant (e.g., if effective and scaled up after the project, what impact might the intervention have on CMV infection rates among pregnant women in the US)?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

· Do the investigators provide evidence of successfully developing and implementing studies of CMV in clinical settings?

· Do the investigators provide evidence of successfully developing and implementing research studies among pregnant women?

· Do the investigators have experience evaluating interventions?

· Do the investigators have adequate experience recruiting the targeted study population and retaining this population in a follow-up study?

· Do staffing plans include, at a minimum, one researcher with experience in gathering quantitative and/or qualitative feedback from populations using tools such as surveys, interviews, or focus groups?

· Do staffing plans include, at a minimum, a clinical researcher or provider experienced in health interventions aimed at the target population?

· Does the research team demonstrate experience working within the clinic sites and collaborating on research studies with clinical staff where the intervention will be implemented and evaluated?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

· Are the intervention strategies defined and described? To what extent are the intervention strategies evidence-based?

· Does the application justify the strategies (e.g., to what extent are the strategies likely to be effective if used properly and to be acceptable to and used by the target population?)

· Does the application describe how the intervention is innovative while building on existing promising approaches to CMV prevention during pregnancy?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

· Does the applicant describe their approach to finalizing intervention parameters, including definitions of prevention strategies, intervention outcomes, intervention approaches or methodologies, and intervention content?

· Does the intervention evaluation propose to use outcome measures that include behavioral outcomes (e.g., uptake of or adherence to prevention strategies) and knowledge outcomes (e.g., knowledge of CMV transmission routes and prevention strategies)?

· Are the participant recruitment strategy, study enrollment procedures, and retention strategies well described and adequate?

· Does the applicant provide power calculations demonstrating that the proposed sample size, taking into account anticipated attrition and the unit of randomization (e.g., individual, group), is sufficient to detect meaningful effects on behavioral change outcomes and includes a minimum of 100 participants (50 per study arm)?

· Does the evaluation design include collection of baseline data and at least one follow-up data collection point during a minimum of 12 weeks of follow-up for individuals who have been randomly assigned to the intervention group and the control group?

· Does the applicant present an adequate plan for data management, including the linkage of questionnaire data with laboratory results, if applicable?

· Does the applicant describe how study data will be analyzed to determine the efficacy of the intervention using appropriate statistical methods?

· Is the proposed timeline sufficiently detailed, complete, and realistic for a 2-year project period (i.e., includes key tasks for intervention development, protocol development, and conduct of the evaluation; and adequate milestones for measuring progress towards completion of these tasks)?

· Does the applicant describe what methods they will use to evaluate patient, provider, and administrative facilitators and barriers to making the CMV SBI feasible as part of routine clinical prenatal care, including approaches such as surveys or interviews Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

· Does the applicant have access to qualified personnel with realistic and sufficient percentage-time commitments relative to each phase of the study timeline? Does applicant describe clear lines of authority, responsibility and supervision for all aspects of the project?

· Does the application provide persuasive evidence that for this project they can enroll and retain at least 100 pregnant women receiving prenatal care?

· Does the application describe the clinical sites and staff, and explain how the physical infrastructure (e.g., lab, exam rooms, conference rooms), typical client flow, and typical staff workload will contribute to and be affected by the implementation of the project, including the intervention itself and the data collection to evaluate the intervention?

· Does the letter of support from the clinical sites spell out the roles and responsibilities of the clinical sites and their staff in the project?

· Does the applicant describe the information technology (equipment, software and expertise) available to the project (e.g., computers, software and programmer for assessments, computers and designer for web and other applications, software and expertise for analyses)?

· Does the application describe physical facilities and procedures for ensuring the confidentiality of the data? For securing the integrity of biological specimens (e.g., labeling, storage, transport)?

· Does the application describe strategies to…