Amendment I (1.13.11):

Page 6 - Updated the Funds Available and Anticipated Number of Awards; and Ceiling and Floor of Individual Award Range.

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)
/ Centers for Disease Control and Prevention (CDC)
Components of Participating Organizations
/ National Center for Immunization and Respiratory Diseases (NCIRD)
Funding Opportunity Title
/ Strategies to Improve Vaccination Coverage of Children in Child Care Centers (CCCs) and Preschools.
Mechanism of Support
/ U01 Research Project Cooperative Agreements
Announcement Type
/ New
Funding Opportunity Announcement (FOA) Number
/ RFA-IP-11-006
Catalog of Federal Domestics Assistance (CFDA) Number(s)
/ 93.185- Immunization Research, Demonstration, Public Information and Education Training and Clinical Skills Improvement Projects.
Category of Funding Activity
/ Health
FOA Purpose
/ This project will generate information on strategies that promote immunization coverage enrolled in child care centers and preschools. Strategies will be developed to improve the ability of child care centers and preschools to ensure that all enrolled children are up-to-date for required immunizations. Other strategies will be examined that improve the ability of local and state government to enforce compliance of CCC’s and preschools with immunization state requirements for enrolled children.

Key Dates

Publication Date
/ January 10, 2011Monday, January 10, 2011
Letter of Intent Due Date
/ Not Applicable
Application Due Date
/ April 12, 2011, by 5:00 PM Eastern Time.
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 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).
Scientific Merit Review
/ June, 2011
Secondary Review
/ July, 2011

Start Date

/ September, 2011

Expiration Date

/ April 13, 2011April 13, 2011

Due Dates for E.O. 12372

/ Due no later than 60 days after the application receipt date.

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

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 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose:

In order to decrease the risk of vaccine-preventable disease for children in group care settings, all states have instituted immunization requirements for children enrolled in licensed child care centers (CCCs) or preschools. In spite of these requirements, studies have demonstrated that immunization coverage among children enrolled in licensed CCCs is no higher than children not enrolled in CCCs.

Children in group settings provide an opportunity to promote vaccination among many preschool-aged children. This research opportunity seeks to identify effective strategies that can improve the ability of CCCs and preschools to ensure that all enrolled children are up-to-date for required immunizations. In addition, this opportunity seeks to identify, develop and study strategies that can improve the ability of local and state government to ensure compliance of licensed CCC’s and preschools with state immunization requirements for enrolled children.

Objectives:

The applicant is required to respond to all objectives.

·  Describe current activities in the study area by local and state government to ensure compliance of licensed child care centers and preschools with state immunization requirements for enrolled children.

·  Identify barriers to local and state governments in ensuring compliance of licensed child care centers and preschools with state immunization requirements for enrolled children.

·  Describe current licensed child care center and preschool knowledge, activities and behaviors and identify barriers to ensuring that all enrolled children are up-to-date for required immunizations.

·  Design, pilot, and evaluate strategies to increase the ability of licensed child care centers and preschools to ensure that all enrolled children are up-to-date for required immunizations.

·  Design, pilot, and evaluate strategies to increase the ability of local and state governments to enforce compliance of licensed child care centers and preschools with state immunization requirements for enrolled children. These may include new strategies to inform CCC’s of new and changing vaccine recommendations.

Research and experimental approaches sought:

In order to describe activities and barriers to ensuring compliance of licensed child care centers and preschools with state immunization requirements for enrolled children, applicants may consider key informant interviews of local and state government staff. Surveys and/or key informant interviews are suggested to assist in describing current knowledge, activities and behaviors and identify barriers to child care centers and preschools in ensuring that all enrolled children are up-to-date for required immunizations.

In developing interventions for pilot testing, applicants should consider barriers to local and state governments in ensuring compliance of licensed child care centers and preschools with immunization state requirements for enrolled children. In addition, other interventions should address barriers to child care centers and preschools in ensuring that all enrolled children are up-to-date for required immunizations, both at initial entry into the facility and periodically during their enrollment.

The applicant should consider designing, pilot testing, and evaluating strategies to be used by local and/or state governments to inform CCC’s and preschools of new and changing vaccine recommendations.

The potential sustainability of interventions should be considered in developing interventions for pilot testing. Applicants should describe how potential interventions will be evaluated in regards to the likelihood that they could be sustained by local and state government or child care and preschool facilities. The cost of the intervention should be considered. This project will involve comparisons of pilot-tested strategies and the project should include piloting of at least three strategies.

Applicants are expected to develop and pilot test innovative strategies in a mix of child care centers and preschools serving a range of subpopulations, including but not limited to facilities located in urban, suburban and rural settings and serving children of varying socioeconomic levels. The child care centers and preschools also should cover a range in size, from a minimum enrollment of at least 10 children on up to facilities with enrollments of over 100 children. Each strategy should be piloted in a minimum of 20 facilities. Facilities may choose to implement multiple strategies.

To the extent that strategies can be tested via a randomized controlled design, the applicant should do so. A minimum enrollment of 20 child care centers and preschools per arm with a total enrollment of over 200 children per arm is suggested. Use of a randomized controlled design will strengthen the application. Some strategies, such as structural changes to systems used by the state or local government, would not be possible to study through a randomized control design.

Piloted strategies should include strategies to ensure that all enrolled children are up-to-date for required immunizations both at initial entry into the licensed child care \ preschool facility and periodically during children’s enrollment at that facility.

The applicant should describe methods for evaluating piloted strategies for effectiveness and acceptability. For example, effectiveness of the strategies may be demonstrated by a significant improvement in actual or recorded immunization coverage of enrollees. Effectiveness of strategies may also be demonstrated through impact of piloted strategies on process measures.

In choosing child care centers and preschools for the design, implementation and evaluation of strategies to increase immunization coverage, the researcher should consider current use of an Immunization Information System by the child care centers and preschools in determining vaccination histories and vaccinations due of clientele.

In this 3 year project period it is anticipated that the first year will be an information gathering and planning year, followed by 2 intervention and evaluation years. Lessons learned in the first intervention year should be used to adjust activities for the subsequent year.

Purchase of vaccine with study-related funds is prohibited as part of this project.

Applicants are expected to provide a research plan that addresses the following elements:

·  Description of methods for collecting data on current activities and barriers to child care centers and preschools ensuring that enrolled children have received required immunizations.

·  Description of methods for collecting data on state and local government activities and barriers to enforcing compliance of child care centers and preschools with immunization state requirements for enrolled children.

·  Description of the types of child care centers and preschools that will be recruited for study participation

·  Description of the strategies that will be pilot tested or how the strategies will be designed based on identification of current activities and barriers.

·  Description of methods to evaluate the different components of the strategies to be pilot tested.

·  Methods for conducting an implementation evaluation to understand the extent to which the components of the strategy were implemented.

Assessing and Reporting the Intervention Translatability of the Research

Applicants must include a plan to estimate and report the potential translatability and public health impact of the research.

Section II. Award Information

Funding Instrument

/ Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

/ New

Funds Available and Anticipated Number of Awards

/ Funds available for the entire program:
Year 1: $300,000
Year 2: $300,000
Year 3: $300,000
Anticipated Number of Awards: 1
Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Ceiling and Floor of Individual Award Range

/ The ceiling for the project is $300,000 per year. The total project period ceiling amount is $900,000.
CDC will not accept and review applications with budgets greater than the ceiling amount.

Project Period Length

/ Project Period Length is 3 years.
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 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

·  Asian American and Native American Pacific Islander-Serving Institution (AAPANISI)

Nonprofits Other Than Institutions of Higher Education

·  Nonprofits (Other than Institutions of Higher Education)

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

All Entities must be states (or bona fide agents of States), political subdivision of States, or other public or nonprofit private entities.

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

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 be renewed annually

·  Grants.gov

·  eRA Commons

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.

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.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.