ci10-00302pphf11 foa final 3.18.11.doc

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Agency Name: Federal Centers for Disease Control and Prevention (CDC) Funding Opportunity Title: Patient Protection and Affordable Care Act (ACA), Emerging Infections Programs (EIP), Enhancing Epidemiology and Laboratory Capacity Announcement Type: Type 5 - Continuation

Agency Funding Opportunity Number: CDC- RFA-CI10-00302PPHF11 Catalog of Federal Domestic Assistance Number: 93.521 Key Dates:

Application Deadline Date: May 2, 2011 Additional Overview Content:

This Announcement represents the second year continuation solicitation for existing EIP recipients to continue and expand their Affordable Care Act (ACA) activities initiated in 2010 under Funding Opportunity Announcement # CI10-003.

Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) and the National Center for Immunization and Respiratory Diseases (NCIRD): (1) protect Americans from infectious diseases, (2) reduce the spread of antimicrobial resistance, (3) protect Americans from death and serious harm caused by medical errors and preventable complications of healthcare, (4) increase the population of children and adults who are free from respiratory infectious disease complications, and (5) strengthen local, state, and national capacity for the early detection, investigation, response and control of respiratory infections in order to accelerate early recognition of respiratory threats and to mitigate the impact of their spread.

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address:

http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf

PART 2. FULL TEXT

I. FUNDING OPPORTUNITY DESCRIPTION

Statutory Authority

Public Health Service Act Sections 301(a) [42 U.S.C. 241(a)] and 317(k) (2) [42 U.S.C. 247b (k) (2)], as amended and the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), Title IV, Sections 4002 and 4304 (Prevention and Public Health Fund).

Background On March 23, 2010, the President signed into law the Patient Protection and Affordable Care Act (ACA). ACA is designed to improve and expand the scope of health care coverage for Americans. Cost savings through disease prevention is an important element of this legislation and ACA has established a Prevention and Public Health Fund (PPHF) for this purpose. Specifically, the legislation states in Section 4002 that the PPHF is to “provide for expanded and sustained national investment in prevention and public health programs to improve health and help restrain the rate of growth in private and public sector health care costs.” In FY2010, CDC initiated a new EIP ACA cooperative agreement (CI10-003) to complement the existing EIP program consistent with the PPHF purpose and build upon EIP’s investment in national, state, and local capacity for emerging infectious diseases in the areas of active surveillance, applied public health epidemiologic and laboratory activities, implementation and evaluation of pilot prevention/intervention projects, and flexible response to public health emergencies.

The purpose of the overall EIP program is to assist in local, state, and national efforts to prevent, control, and assess the public health impact of emerging infectious diseases. The EIPs are a network of 10 state health departments working with collaborators in local health departments, public health laboratories, and clinical laboratories; infection control professionals; healthcare providers; and academic institutions. Activities of the EIPs fall into these general categories of research and non-research activities: (1) active surveillance; (2) applied public health epidemiologic and laboratory activities; (3) implementation and evaluation of pilot prevention/intervention projects; and (4) flexible response to public health emergencies. Network activities go beyond routine functions of health departments by addressing the most important issues in infectious diseases and selecting projects that the EIP network is particularly suited to investigate; maintaining sufficient flexibility for emergency response and addressing new problems as they arise; developing and evaluating public health interventions and ultimately transferring what is learned to public health agencies; incorporating training as a key function of EIP activities; and giving high priority to projects that lead directly to the prevention of disease (http://www.cdc.gov/ncpdcid/deiss/eip/index.html).

The EIP network is guided by the EIP Steering Group which consists of representatives from each EIP site and representatives from various CDC programs. The group meets annually and conference calls are held quarterly to discuss important issues. The group’s primary purpose is to set general scientific directions for EIP activities, make decisions that affect the EIPs overall, follow the scientific progress of EIP activities, and ensure that sites adhere to EIP guiding principles. Subcommittees or workgroups are convened as needed around specific programmatic areas.

Purpose

The purpose of the EIP-ACA cooperative agreement is to support state and local health departments’ surveillance infrastructure through enhancement of the epidemiology and laboratory capacity of the existing EIP network. Over the past 16 years, the EIP network has proved to be a national resource for conducting active, population-based surveillance and special studies for invasive bacterial diseases, foodborne pathogens, healthcare associated infections (HAIs), influenza, and many other infectious diseases. The network has been instrumental in measuring the impact of the 7-valent pneumococcal conjugate vaccine, informing and evaluating treatment guidelines for Group B Streptococcus, estimating the burden of foodborne illness, documenting the emergence of community-associated methicillin-resistant Staphylococcus aureus, and monitoring the safety of the 2009 H1N1 vaccine as part of the influenza vaccine safety network (http://www.cdc.gov/ncpdcid/deiss/eip/publications.html ).

The flexibility of the EIP network is critical so that activities and special studies can adapt to changing priorities for infectious disease emergency response and program areas. These investments in the basic infrastructure support multiple activities at each site and are critical for a comprehensive, efficient, and coordinated approach to general program management from which all activities benefit. EIP sites may conduct up to 65 different surveillance and research activities related to infectious diseases during the course of a year. These activities require investments in personnel time to implement or modify, including building collaborative relationships with local hospitals, laboratories, and healthcare providers; submitting applications to multiple institutional review boards for dozens of studies; hiring, supervising and training staff; facilitating information exchange between CDC, local epidemiologists and laboratories; and actively participating in numerous conference calls, conferences, and meetings with CDC investigators. This cooperative agreement provides an opportunity to enhance support for the basic infrastructure of the EIP network as well as to enhance EIP programmatic activities.

Specifically, the objective of FY2011 funding for the ELC-ACA cooperative agreement is to continue to build and support EIP infrastructure through the following activities:

1. Infrastructure Support

· Support of personnel, including but not limited to supervisory scientists and program managers, who have responsibilities across multiple EIP activities.

· Education/ training opportunities related to infectious diseases.

· Information technology and exchange efforts that are consistent with applicable standards (e.g., HHS/CDC) and that can be used for multiple EIP activities at a site.

2. Enhancement of general epidemiology and laboratory capacity related to immunizations and respiratory diseases.

A. Enhanced Pertussis Surveillance and Evaluation of U.S. Pertussis Vaccination Program:

Despite high coverage with pertussis-containing childhood vaccines, Bordetella pertussis is the most poorly controlled bacterial vaccine-preventable disease in the U.S., with peaks in reported disease every 3-5 years. Since the 1980s, reported pertussis cases have trended upwards with notable increases among adolescents and adults. In 2005, pertussis booster vaccines (Tdap) were recommended for adolescents and adults, with an emphasis on directly preventing disease in vaccinated adolescents and adults and indirectly protecting vulnerable infant populations at risk for severe or fatal disease through vaccination of close contacts (‘cocooning’). While the largest post-vaccine peak was observed in 2005 (>25,000 reported cases), several states have reported unprecedented increases in the number of pertussis cases in 2010 suggesting that the overall burden of disease in 2010 could rival rates of disease in 2005. To date, >21,000 cases have been reported for 2010. Furthermore, reports suggest a shift in the burden of disease to younger, fully- vaccinated age groups, possibly suggesting decreased effectiveness of DTaP vaccines. Understanding the clinical effectiveness and duration of protection of currently licensed pertussis vaccines (DTaP and Tdap) is critical for guiding vaccination policy.

Strong surveillance platforms are the foundation for the successful evaluation of vaccination programs. Funds are available to enhance surveillance efforts needed to evaluate effectiveness of pertussis vaccines.

B. Meningococcal Conjugate Vaccine Evaluation

The burden of meningococcal disease in adolescents in the United States is substantial. Of the over 250 cases that occur annually among 11-18 year-olds, 10-15% are fatal and an additional 10-15% have long-term sequelae such as limb loss, hearing loss, or neurologic deficits. Two quadrivalent meningococcal conjugate vaccines are licensed in the United States. These vaccines protect against four serogroups (A, C, Y, and W) that cause approximately 75% of disease occurring in adolescents. The great majority of this disease burden is caused by serogroups C and Y, while A and W135 are exceedingly rare. ACIP recommends vaccination of all adolescents aged 11-18 years and other persons aged 2-55 years at increased risk for meningococcal disease. There are limited data on the effectiveness of meningococcal conjugate vaccine or the duration of protection. Pre-licensure clinical trials were immunogenicity studies.

Over 4 million adolescents are vaccinated annually against meningococcal disease. This vaccine is one of three vaccines recommended for adolescents at 11-18 years-old, preferably at the 11-12 year-old vaccination visit. In 2010, a booster dose was recommended at age 16 years. There are little data in the United States about how adolescents respond to conjugate vaccines. Post-licensure vaccine effectiveness investigations are important to assess vaccine performance under conditions of community use. For example, they may also provide insight into how adolescents respond to vaccines given outside of clinical trials. A case-control investigation of the effectiveness of meningococcal conjugate vaccine has been implemented since 2006 in the 10 EIP Active Bacterial Core surveillance sites and an additional 19 sites participating in CDC’s MeningNet. Preliminary estimates of vaccine effectiveness from this evaluation suggest that protection wanes over time, but these estimates are based on information about only one of the two vaccines now licensed.

Funds are available to continue evaluation of the effectiveness of meningococcal conjugate vaccines. In order to inform policy regarding meningococcal vaccination in the United States, this project will support EIP sites to identify all cases of meningococcal disease and enroll cases of serogroup C and Y disease among persons aged >11 years and born on or after January 1, 1986, currently aged 11-23 years, in a case-control meningococcal conjugate vaccine investigation design. The specific objectives include 1) to evaluate the effectiveness of a single dose of Meningococcal conjugate vaccine against meningococcal disease caused by serogroups C and Y in adolescents aged >11 years and born on or after January 1, 1986, currently aged 11-23 years, using a case-control approach and 2) to evaluate duration of protection of Meningococcal conjugate vaccines during the evaluation period.

C. Pneumococcal Conjugate Vaccine Evaluation

In the U.S., Streptococcus pneumoniae (pneumococcus) is a common cause of otitis media, bacteremia, pneumonia, and meningitis and it is the most common vaccine-preventable bacterial cause of death. The highest rates of severe infection occur among children <5 years of age and among adults >65 years of age. Rates of disease are also elevated in persons of any age with chronic underlying conditions, such as diabetes, lung disease, and immunosuppressive conditions (e.g., HIV infection). In 2000, a 7-valent pneumococcal conjugate vaccine (PCV7, Prevnar®, Wyeth) was introduced into the routine immunization schedule in the U.S. for children 2, 4, 6, and 12-15 months of age. Since then, overall rates of the severest forms of pneumococcal disease (e.g., bacteremia, meningitis) among children <5 years old have declined almost 80% percent, with rates of disease caused by PCV7 serotypes declining >99%. Because PCV7 also prevents transmission of pneumococcus to unvaccinated persons, rates of severe PCV7-type pneumococcal disease have declined among older children and adults by approximately 90%. The remaining burden of disease and modest increases in some non-PCV7 serotypes (e.g., serotype 19A) provide an opportunity for further prevention efforts.

A new 13-valent pneumococcal conjugate vaccine (PCV13) containing the PCV7 serotypes plus six others (including serotypes 19A and 3) was approved for routine use in infants in February 2010. PCV13 was licensed using serologic and safety data only. Therefore, performing post-licensure efforts to demonstrate vaccine effectiveness against disease is critical to making sure we are investing wisely in this vaccine. Since June of 2010, multiple partners around the U.S. have been participating in an evaluation of the effectiveness of PCV13.

Funds are available to continue evaluation of the effectiveness of PCV13 in the EIP sites. The EIP network is optimal for conducting this evaluation because of the scale and complexity and the network’s past experience with successfully performing similar evaluations. It will be several years before such data are available from any other country. If PCV13 is highly effective, we will have a narrow window of approximately two years after vaccine licensure during which this evaluation will be possible.

Note that the influenza and bloodstream infections activities funded in the 2010 1st Budget Period awards under CI10-003 were one-time only and no 2011 continuation funding is available for these activities.

This program addresses the “Healthy People 2020” focus area(s) of Immunization and Infectious Diseases and Public Health Infrastructure.

Program Implementation Recipient Activities

Applicants may address one or more of the following Activities:

1. Infrastructure Support:

A. Personnel who provide scientific leadership, coordination, execution, and/or effective management of EIP activities (i.e., senior scientific and/or management personnel such as EIP Coordinator/Manager, Epidemiologists, Surveillance Officers, etc.).

B. Educational and training opportunities related to infectious diseases. This may include, but is not limited to, offering continuing education credits or certifications, purchasing epidemiology or laboratory guide books/ manuals/ reference material, and conducting training/informational webinars or seminars.

C. Development, management, and collaboration with CDC on standard and interoperable information systems used across EIP activities.

2. Enhancement of epidemiology and laboratory capacity for existing EIP activities. One or more of the specific projects (A-C) below may be addressed under this category:

A. Enhanced Pertussis Surveillance and Evaluation of U.S. Pertussis Vaccination Program

1) Perform enhanced surveillance for Bordetella pertussis to improve case finding for pertussis vaccine evaluations.

a. Utilize state-based pertussis reporting systems to conduct routine surveillance for pertussis with systematic case investigation and follow-up.

b. Collect complete information on clinical course of infection, vaccination history (including information on vaccination dates, lot numbers and manufacturers), and other epidemiologic information of interest (e.g., source of infection).

c. Collect isolates of Bordetella pertussis, when available, and ship to CDC for further molecular characterization.

d. Utilize state immunization registries to obtain and/or verify vaccine history.

2) Evaluate the effectiveness of the “cocooning” Tdap vaccination strategy at preventing pertussis among infants <6 months.

a. Implement a protocol for enrolling cases and controls in a case-control investigation of the effectiveness of cocooning.

b. Seek approval from CDC and local institutional review boards (IRBs), as appropriate.

c. Develop and pilot data collection instruments (e.g., questionnaires, vaccine history forms) and enrollment procedures.

d. Begin enrollment of pertussis cases <6 months of age identified through routine surveillance; enroll 3 age- and zipcode-matched controls, identified through birth certificates, for each identified case. Enrollment projected to begin late spring/early summer 2011.

e. Collect data from consenting parents/guardians of enrolled subjects through phone interview, and obtain provider-verified vaccination history for all participating subjects as well as household contacts.

f. Utilize CDC-developed data management systems and routinely transmit data collected on cases and controls to CDC.

g. Participate in routine conference calls with CDC and other participating sites to discuss progress, monitor enrollment, and address methodology-related questions.

3) Build and strengthen infrastructure to conduct timely and urgent evaluations of the U.S. pertussis vaccination program.

a. Identify question(s) of interest (e.g., clinical effectiveness and duration of protection of currently licensed pertussis vaccines.

b. In collaboration with CDC, develop protocols and identify appropriate methodology.

c. Initiate/conduct studies as funding permits.

d. Utilize vaccination registries where feasible.

e. Utilize findings to make modifications to and optimize the national pertussis immunization program.

B. Evaluation of Meningococcal Conjugate Vaccine (MCV)

1) Identify and serogroup all cases of meningococcal disease (defined by isolation from a normally sterile site or detection of meningococcal DNA on polymerase chain reaction) in the entire state or proposed catchment area in which enrollment will occur.

2) Transfer all isolates and specimens to CDC for confirmation of serogroup.

3) Implement a protocol for enrolling cases and controls in a case-control investigation of vaccine effectiveness. This includes participating in conference calls and training sessions, collecting data including consenting participants, and transmitting data to CDC.

4) Complete case investigations to determine demographic information, clinical presentation and outcome, vaccination status, type of vaccine, and date of vaccine for all cases of meningococcal disease, and vaccination status, type of vaccine, and date of vaccination for controls enrolled in the investigation.

5) Enhance meningococcal surveillance, including laboratory detection of Niesseria meningitidis, to improve case finding for meningococcal vaccine evaluations.

C. Evaluation of Pneumococcal Conjugate Vaccine (PCV)

1) Collaborate with CDC and other EIP sites via conference calls to develop protocols which will include enrollment criteria, procedures for identifying appropriate controls and procedures for requesting participation from cases and controls.

2) Develop and pilot test instruments (e.g., questionnaires, chart abstract forms) and enrollment procedures to be used in the evaluation.

3) Work with CDC to develop appropriate data systems that allow for secure collection and electronic transmission of data related to enrolled cases and controls.

4) Identify all cases of IPD (defined by isolation of pneumococcus from normally sterile body sites) in residents of the 2009 catchment areas used for ABCs pneumococcal surveillance. Identification of all cases is necessary to establish the baseline incidence of disease and to minimize any bias (especially toward more severe presentations) in case enrollment. Awardees are encouraged to consider expanding their 2009 surveillance areas for the purpose of increasing the potential number of cases enrolled.

5) Attempt to obtain pneumococcal isolates from all cases for storage and subsequent shipment to existing ABCs reference laboratories (CDC, Minnesota Department of Health, University of Texas Health Sciences Center, San Antonio).

6) Enroll cases (identified from ABCs surveillance) and age-matched controls (identified by searching of birth certificates or another method mutually agreed upon with CDC), beginning after PCV-13 licensure and vaccine use among U.S. infants commences.

7) Collect vaccine histories and information on potential risk factors for disease through interviews with parents of enrolled children and contact with their healthcare providers.

8) Transmit to CDC data collected on cases and controls using data systems and timelines described above.

9) Collaborate with CDC to monitor enrollment, analyze data, interpret results, and prepare reports for presentation and publication.

In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring.

CDC Activities

· Provide general coordination for all EIP recipients as a network.

· Develop and facilitate collaborative multi-site relationships as needed to support the successful completion of the project.

· Provide consultation, scientific and technical assistance as necessary in the operation of the EIP. This may include:

· Leading the development of evaluation protocols and procedure manuals,

· Training grantee personnel,

· Designing projects,

· Facilitating the development of information systems,

· Serotyping isolates,

· Performing antimicrobial susceptibility testing,

· Analyzing and interpreting data,

· Disseminating results, and

· Coordinating and facilitating communications among EIPs.

· Consult with sites to assist evolution of EIP-related information systems to conform to applicable (e.g., HHS, CDC) standards.

II. AWARD INFORMATION

Type of Award: Cooperative Agreement. CDC substantial involvement in this program appears in the Activities Section above.

Award Mechanism: U01

Fiscal Year Funds: 2011 Approximate Current Fiscal Year Funding: $7,068,000. This amount is subject to availability of funds. Approximate funding available by Activity:

Activity 1 – Infrastructure: $2,600,000

Activity 2.A. – Pertussis: $2,210,000

Activity 2.B. – MCV: $360,000

Activity 2.C. – PCV: $1,898,000 Approximate Number of Awards: 10 Approximate Average Award: $706,800 (This amount is for a 12-month budget period, and includes both direct and indirect costs.)

Floor of Individual Award Range: None.

Ceiling of Individual Award Range: $1,000,000. This ceiling is for a 12-month budget period, and includes both direct and indirect costs.

Anticipated Award Date: June 15, 2011 Budget Period Length: 12 months (September 30, 2011 – September 29, 2012) Project Period Length: This is the second budget period continuation for the 24-month Project Period that began September 30, 2010.

First Budget Period: September 30, 2010 – September 29, 2011 Second Budget Period: September 30, 2011 – September 29, 2012

III. ELIGIBILITY INFORMATION

Eligible Applicants

This Announcement provides second Budget Period continuation funding for EIP-ACA awards initiated in 2010 under FOA# CI10-003. Therefore, eligibility is limited to current grantees (or their Bona Fide Agents) funded under FOA# CI10-003, which are the health departments of California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Oregon, and Tennessee.

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.

Required Registrations 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.

The recipient is required to have the original DUNS identifier to apply for additional funds.

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 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 their CCR 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.

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

Cost Sharing or Matching

Cost sharing or matching funds are not required for this program.

Other

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 a grant, loan, or an award.

Maintenance of Effort:

Maintenance of Effort is not required for this program.

IV. Application and Submission Information Address to Request Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity from 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 for further instruction. 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.

Content and Form of Application Submission Unless specifically indicated, this announcement requires submission of the following information:

A Project Abstract must be completed in the Grants.gov application forms. The Project Abstract must contain a summary of the proposed activity suitable for dissemination to the public. It should be a self-contained description of the project and should contain a statement of objectives and methods to be employed. It should be informative to other persons working in the same or related fields and insofar as possible understandable to a technically literate lay reader. This abstract must not include any proprietary/confidential information.

A Project Narrative must be submitted with the application forms. The project narrative must be uploaded in a PDF file format when submitting via Grants.gov. The narrative must be submitted in the following format:

· Maximum number of pages: 25 pages

· Font size: 12 point unreduced, Times New Roman

· Single spaced

· Page margin size: One inch

· Number all narrative pages; not to exceed the maximum number of pages.

The narrative should address activities to be conducted over the entire project period and must include the following items in the order listed:

A. Current Budget Period Progress:

Provide a detailed report on progress towards all objectives/activities funded in the current budget period (9/30/2010 – 9/29/2011). For each objective/activity, as relevant, describe the following:

· Evidence of how funding is being used to strengthen EIP infrastructure (e.g., staff hired, education/training completed, improvements in informatics efforts)

· Current status of project objectives (met, ongoing, or unmet). Also specifically address progress against each measure of effectiveness included in your 2010 EIP ACA proposal for each funded Activity.

· Any major findings, significance of those findings, and how the findings impact or contribute to the public health goal

· Barriers encountered and how the barriers were addressed

· If applicable, include the reasons that goals were not met and a discussion of assistance needed to resolve the situation

· In addition to programmatic progress, specifically describe progress in spending the funds awarded for the first budget period (see also the requirements for submitting the Financial Status Report in paragraph B.5. Budget, below). Describe progress in filling positions (i.e., number funded in the Sept 2010 award, number filled as of x date, number expected to be filled by July 31, 2011). Describe progress in implementing any contracts, major equipment purchases, etc. Describe any challenges you may be experiencing in making expenditures and your plans to address them.

B. New Funding Period Proposed Objectives and Activities:

List proposed objectives and activities for the upcoming funding period (September 30, 2011 – September 29, 2012). Please reference the “Budget Information and Justification” section below for the appropriate time periods to address for specific Activities.

Separate narratives and budgets must be submitted for each Activity for which you are requesting funds:

Activity 1 - Infrastructure Support Activity 2.A. - Enhanced Pertussis Surveillance and Evaluation of U.S. Pertussis Vaccination Program Activity 2.B. - Meningococcal Conjugate Vaccine Evaluation Activity 2.C. - Pneumococcal Conjugate Vaccine Evaluation Applicants may choose to address one or more of the Activities. Each Activity narrative should contain the following sections in the order listed (see also Recipient Activities on p. 8 for details):

1. Background and Understanding

Describe the current capacity of your infrastructure to support the amount of EIP work in your state and/or the current level of activity in your EIP regarding the specific project (e.g., describe current surveillance activities for pertussis, meningococcal disease, and invasive pneumococcal disease, as well as current participation in case-control vaccine evaluations- this may include collection of complete case report form information (including vaccine history) and isolates, when available or applicable)

2. Need

Describe the gaps that necessitate expanding and/or sustaining the basic epidemiology and laboratory infrastructure and capacity in your EIP or the specific project.

3. Operational Plan

· Describe the required staff, their responsibilities, and how they will be trained.

· Describe objectives that are specific, measurable, achievable, and relevant.

· For projects 2.A, 2.B, and 2.C, details should be provided regarding counties to be included as catchment areas, the approximate size of the relevant populations (<2 yrs old only, 3-59mths, etc for PCV; 11-23 yrs old or approximate size of undergraduate college population for MCV), estimate of the number of cases of disease occurring in catchment area for the most recent year available, plans to ensure capacity to enroll cases and controls in vaccine evaluations per protocols, and plans to assess and ensure quality of data transmitted to CDC.

· Include a clear timeline for achieving the stated objectives that demonstrates rapid implementation of activities.

4. Measures of Effectiveness

Describe quantifiable measures of effectiveness or impact of activities (e.g., number of cases of identified, number (%) of cases enrolled, number (%) of controls enrolled, number of complete case/control sets enrolled, proportion of enrolled cases from which isolates are forwarded for serotyping, proportion of enrolled cases and controls with provider verified vaccination status reported, proportion of cases with isolates linked to pertussis cases). Applicants may also develop their own measures of effectiveness or impact.

5. Budget Information and Justification Provide a fully detailed budget with narrative justification for the second budget period. Please note the time periods below to address for each Activity:

Activity 1 – Infrastructure: September 30, 2011 – September 29, 2012 (12 months) Activities2.A-C – Pertussis, MCV, PCV:

December 30, 2011 – September 29, 2012 (9 months only as these activities are currently supported under other EIP FOAs through December 29, 2011) All budgets must be clearly broken out into the line-item categories specified in Form 424 (Salary, Fringe, Travel, Supplies, Equipment, Contractual, Other, and Indirect Costs). The budget must be consistent with stated program objectives and planned activities outlined in the operational plan. The budgets and budget justifications will not be counted in the narrative page limit. Be sure to consider and include requests for travel that may be necessary for proposed activities. Travel that is approved and funded by CDC will be considered a required activity.

Financial Status Report (SF 269):

As this is a continuation of your EIP-ACA award initiated in 2010 under FOA# CI10-003, it is REQUIRED that you provide in the application an estimate of the overall obligations for the current budget period by submitting an interim Financial Status Report (FSR), form SF 269, for the current budget period that began September 30, 2010 (see also narrative reporting requirements in paragraph A- Current Budget Period Progress, above). The form is available on the CDC internet at http://www.cdc.gov/od/pgo/forminfo.htm. The interim FSR must reflect all funds awarded in the current first budget period of this opportunity and estimated expenditures for the full 12-month first budget period that ends September 29, 2011. Therefore, the resulting unobligated balance (if any) will be an estimate of what will remain unobligated as of September 29, 2011.

Additional information may be included in the application appendices. The appendices must be uploaded to the “Other Attachments Form” of application package in Grants.gov. Note: Appendices will not be counted toward the narrative page limit. This additional information includes:

· Curricula Vitae (combine all CVs into one attachment)

· Organizational Chart

· Letters of Support (combine all Letters of Support into one attachment)

· Indirect cost rate agreements

Additional information submitted via Grants.gov must be uploaded in a PDF file format, and should be named:

· Curricula Vitae

· Organizational Chart

· Letters of Support

· Indirect cost rate agreements No more than 10 appendices should be uploaded per application.

CDC Assurances and Certifications can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm and is required for competing continuations.

Additional requirements for additional documentation with the application are listed in Section VI. Award Administration Information, subsection entitled “Administrative and National Policy Requirements.”

Submission Dates and Times

This announcement is the definitive guide on application content, submission, and deadline. It supersedes information provided in the application instructions. If the application submission does not meet the deadline published herein, it will not be eligible for review and the recipient will be notified the application did not meet the submission requirements.

Application Deadline Date: May 2, 2011 Explanation of Deadlines: Application must be successfully submitted to Grants.gov by 5:00pm Eastern Standard Time on the deadline date.

Intergovernmental Review

This is a continuation of a current grant program and so is not subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (EO) 12372.

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

· Recipients may not use funds for research.

· Recipients may not use funds for clinical care.

· Recipients may only expend funds for reasonable program purposes, including personnel, travel, supplies, and services, such as contractual.

· Awardees may not generally use HHS/CDC/ATSDR funding for the purchase of furniture or equipment. Any such proposed spending must be identified in the budget.

· The direct and primary recipient in a cooperative agreement program must perform a substantial role in carrying out project objectives and not merely serve as a conduit for an award to another party or provider who is ineligible.

The recipient can obtain guidance for completing a detailed justified budget on the CDC website, at the following Internet address: http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

Other Submission Requirements Application Submission Submit the application electronically by using the forms and instructions posted for this funding opportunity on www.Grants.gov. If access to the Internet is not available or if the recipient encounters difficulty in accessing the forms on-line, contact the HHS/CDC Procurement and Grant Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 for further instruction.

Note: Application submission is not concluded until successful completion of the validation process. After submission of your application package, recipients will receive a “submission receipt” email generated by Grants.gov. Grants.gov will then generate a second e-mail message to recipients which will either validate or reject their submitted application package. This validation process may take as long as two (2) business days. Recipients are strongly encouraged check the status of their application to ensure submission of their application package is complete and no submission errors exists. To guarantee that you comply with the application deadline published in the Funding Opportunity Announcement, recipients are also strongly encouraged to allocate additional days prior to the published deadline to file their application. Non-validated applications will not be accepted after the published application deadline date.

In the event that you do not receive a “validation” email within two (2) business days of application submission, please contact Grants.gov. Refer to the email message generated at the time of application submission for instructions on how to track your application or the Application User Guide, Version 3.0 page 57.

Electronic Submission of Application:

Applications must be submitted electronically at www.Grants.gov. Electronic applications will be considered as having met the deadline if the application has been successfully made available to CDC for processing from Grants.gov on the deadline date.

The application package can be downloaded from www.Grants.gov. Recipients can complete the application package off-line, and then upload and submit the application via the Grants.gov website. The recipient must submit all application attachments using a PDF file format when submitting via Grants.gov. Directions for creating PDF files can be found on the Grants.gov website. Use of file formats other than PDF may result in the file being unreadable by staff.

Applications submitted through Grants.gov (http://www.grants.gov), are electronically time/date stamped and assigned a tracking number. The AOR will receive an e-mail notice of receipt when HHS/CDC receives the application. The tracking number serves to document submission and initiate the electronic validation process before the application is made available to CDC for processing.

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

Organizations that encounter technical difficulties in using www.Grants.gov to submit their application must attempt to overcome those difficulties by contacting the Grants.gov Support Center (1-800-518-4726, support@grants.gov). After consulting with the Grants.gov Support Center, if the technical difficulties remain unresolved and electronic submission is not possible to meet the established deadline, organizations may submit a request prior to the application deadline by email to the Grants Management Specialist/Officer for permission to submit a paper application. An organization's request for permission must: (a) include the Grants.gov case number assigned to the inquiry, (b) describe the difficulties that prevent electronic submission and the efforts taken with the Grants.gov Support Center (c) be submitted to the Grants Management Specialist/Officer at least 3 calendar days prior to the application deadline. Paper applications submitted without prior approval will not be considered.

If a paper application is authorized, the recipient will receive instructions from PGO TIMS to submit the original and two hard copies of the application by mail or express delivery service.

V. Application Review Information

Eligible recipients are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of this FOA. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures of effectiveness must be objective, quantitative and measure the intended outcome of the proposed program. The measures of effectiveness must be included in the application and will be an element of the evaluation of the submitted application.

Criteria Eligible recipients will be evaluated against the following criteria:

Background and Understanding (10 points): Does the applicant demonstrate a clear and comprehensive understanding of the underlying public health issue that this opportunity targets?

Need (30 points): Does the applicant justify the need for these resources? Does the applicant adequately describe how the work funded in this program should complement but not duplicate ongoing work in the EIP being funded by other sources (e.g., state/local funds, other cooperative agreements)?

Operational Plan (40 points): Is the plan adequate to carry out the proposed objectives? Is there a clear and appropriate timeline for implementation? Do the staff members have appropriate experience? Are the staff roles clearly defined? As described, will the staff be sufficient to accomplish the program goals?

Measures of Effectiveness (20 Points): Does the applicant provide measures of effectiveness for each request or activity that will demonstrate accomplishment of the cooperative agreement objectives identified in the “Purpose” section of this program announcement? Are the measures objective and quantitative, and do they adequately measure the intended outcome of each request or activity?

Budget (SF 424A) and Budget Narrative (Reviewed, but not scored): Although the budget is not scored recipients should consider the following in development of their budget. Is the itemized budget and justification reasonable, appropriate, and consistent with the stated objectives of the FOA? Is the required interim FSR included in the application?

If the applicant requests indirect costs in the budget, a copy of the indirect cost rate agreement is required. If the indirect cost rate is a provisional rate, the agreement should be less than 12 months of age. The indirect cost rate agreement should be uploaded as a PDF file with “Other Attachment Forms” when submitting via Grants.gov.

Review and Selection Process

Review All eligible applications will be initially reviewed for completeness by the Procurement and Grants Office (PGO) staff. In addition, eligible applications will be jointly reviewed for responsiveness by the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), the National Center for Immunization and Respiratory Diseases (NCIRD), and PGO. Incomplete applications and applications that are non-responsive will not advance through the review process. Applicants will be notified the application did not meet eligibility and/or published submission requirements.

A structured review will be conducted to evaluate complete and responsive applications according to the criteria listed in the “V. Criteria” section above. The review will be conducted by program staff in the National Center for Zoonotic and Emerging Infectious Diseases (NCEZID) and the National Center for Immunization and Respiratory Diseases (NCIRD). As part of the review process, each applicant will receive a written Technical Review that summarizes the review findings regarding strengths, weaknesses, and recommendations.

Selection

All eligible responsive applications will be selected for funding. Specific levels of funding for the different Activities will be based upon the structured review findings.

VI. Award Administration Information Award Notices

Successful recipients will receive a Notice of Award (NoA) from the CDC Procurement and Grants Office. The NoA shall be the only binding, authorizing document between the recipient and CDC. The NoA will be signed by an authorized Grants Management Officer and e-mailed to the program director. A hard copy of the NoA will be mailed to the recipient fiscal officer identified in the application.

Unsuccessful recipients will receive notification of the results of the application review by mail.

Administrative and National Policy Requirements

Successful recipients must comply with the administrative requirements outlined in 45 Code of Federal Regulations (CFR) Part 74 or Part 92, as appropriate. For competing supplements, ARs remain in effect as published in the original announcement. The following additional requirements apply to this project:

· AR-7

Executive Order 12372

· AR-8

Public Health System Reporting Requirements

· AR-9

Paperwork Reduction Act Requirements

· AR-10

Smoke-Free Workplace Requirements

· AR-11

Healthy People 2010

· AR-12

Lobbying Restrictions

Additional information on the requirements can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/Addtl_Reqmnts.htm.

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 Reporting

FFATA Reporting Requirements:

Federal Funding Accountability And Transparency Act Of 2006 (FFATA): Public Law 109-282, the Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), requires full disclosure of all entities and organizations receiving Federal funds including grants, contracts, loans and other assistance and payments through a single publicly accessible Web site, USASpending.gov. The Web site includes information on each Federal financial assistance award and contract over $25,000, including such information as:

1. The name of the entity receiving the award

2. The amount of the award

3. Information on the award including transaction type, funding agency, etc.

4. The…